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Trial record 14 of 47 for:    test | ( Map: Gambia )

Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety & Immunogenicity in Children & Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01262872
Recruitment Status : Completed
First Posted : December 17, 2010
Results First Posted : April 21, 2014
Last Update Posted : June 19, 2019
Sponsor:
Collaborators:
PATH
Department of State for Health and Social Welfare, The Gambia
Medical Research Council Unit, The Gambia
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Infections, Streptococcal
Interventions Biological: Pneumococcal vaccine GSK 2189242A (LD formulation 1)
Biological: Pneumococcal vaccine GSK 2189242A (HD formulation 2)
Biological: Synflorix™
Biological: Prevnar13™
Biological: Tritanrix™-HepB/Hib
Biological: Polio Sabin™
Biological: M-Vac™
Biological: Stamaril™
Enrollment 1320
Recruitment Details Cohort 1 subjects participated in Step 1 (duration of about 6 months). Cohort 2 subjects participated in Step 2 (duration of about 10 months). Enrolment for Step 2 was conditional upon successful results of a post-vaccination safety evaluation of all children enrolled in Cohort 1 by an Independent Data Monitoring Committee.
Pre-assignment Details Description of any significant events and approaches for the overall study following participant enrollment, but prior to group assignment.
Arm/Group Title 10PP-HD 1d Group Prevnar13 1d Group 10PP-LD 3+0d Group 10PP-HD 3+0d Group Synflorix 3+0d Group Prevnar13 3+0d Group 10PP-HD 2+1d Group Synflorix 2+1d Group
Hide Arm/Group Description This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid. This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid. This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally. This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally. This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally. This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally. This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally. This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Period Title: Step 1
Started 60 60 0 [1] 0 [1] 0 [1] 0 [1] 0 [1] 0 [1]
Completed 60 60 0 [1] 0 [2] 0 [1] 0 [1] 0 [1] 0 [1]
Not Completed 0 0 0 0 0 0 0 0
[1]
The 2 first groups included subjects for Step 1 alone. The 6 other groups were part of Step 2 alone.
[2]
The 2 first groups included subjects for Step 1 alone. The 6 other groups were part of Step 2 alone
Period Title: Step 2
Started 0 [1] 0 [1] 200 200 200 200 200 200
Completed 0 [1] 0 [1] 191 190 195 191 191 194
Not Completed 0 0 9 10 5 9 9 6
Reason Not Completed
Death             0             0             0             1             0             2             2             1
Protocol Violation             0             0             1             0             0             0             3             1
Withdrawal by Subject             0             0             4             6             3             1             2             1
Migrated/moved from study area             0             0             4             3             2             6             2             3
[1]
The 2 first groups included subjects for Step 1 alone. The 6 other groups were part of Step 2 alone.
Arm/Group Title 10PP-HD 1d Group Prevnar13 1d Group 10PP-LD 3+0d Group 10PP-HD 3+0d Group Synflorix 3+0d Group Prevnar13 3+0d Group 10PP-HD 2+1d Group Synflorix 2+1d Group Total
Hide Arm/Group Description This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid. This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid. This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally. This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally. This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally. This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally. This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally. This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally. Total of all reporting groups
Overall Number of Baseline Participants 60 60 200 200 200 200 200 200 1320
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 200 participants 200 participants 200 participants 200 participants 200 participants 200 participants 1320 participants
2.8  (0.40) 2.9  (0.36) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 2.9  (0.38)
[1]
The 2 first groups included subjects for Step 1 alone. The 6 other groups were part of Step 2 alone.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 60 participants 60 participants 200 participants 200 participants 200 participants 200 participants 200 participants 200 participants 1320 participants
NA [1]   (NA) NA [1]   (NA) 8.5  (0.64) 8.4  (0.61) 8.4  (0.63) 8.5  (0.69) 8.5  (0.70) 8.5  (0.70) 8.5  (0.66)
[1]
The 2 first groups included subjects for Step 1 alone. The 6 other groups were part of Step 2 alone.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 200 participants 200 participants 200 participants 200 participants 200 participants 200 participants 1320 participants
Female
41
  68.3%
26
  43.3%
NA [1]  NA [1]  NA [1]  NA [1]  NA [1]  NA [1]  NA [2] 
Male
19
  31.7%
34
  56.7%
NA [1]  NA [1]  NA [1]  NA [1]  NA [1]  NA [1]  NA [2] 
[1]
The 2 first groups included subjects for Step 1 alone. The 6 other groups were part of Step 2 alone.
[2]
Total not calculated because data are not available (NA) in one or more arms.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 200 participants 200 participants 200 participants 200 participants 200 participants 200 participants 1320 participants
Female NA [1]  NA [1] 
105
  52.5%
98
  49.0%
103
  51.5%
103
  51.5%
103
  51.5%
97
  48.5%
NA [2] 
Male NA [1]  NA [1] 
95
  47.5%
102
  51.0%
97
  48.5%
97
  48.5%
97
  48.5%
103
  51.5%
NA [2] 
[1]
The 2 first groups included subjects for Step 1 alone. The 6 other groups were part of Step 2 alone.
[2]
Total not calculated because data are not available (NA) in one or more arms.
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
African heritage Number Analyzed 60 participants 60 participants 200 participants 200 participants 200 participants 200 participants 200 participants 200 participants 1320 participants
60
 100.0%
60
 100.0%
NA [1]  NA [1]  NA [1]  NA [1]  NA [1]  NA [1]  NA [2] 
[1]
The 2 first groups included subjects for Step 1 alone. The 6 other groups were part of Step 2 alone.
[2]
Total not calculated because data are not available (NA) in one or more arms.
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
African heritage Number Analyzed 60 participants 60 participants 200 participants 200 participants 200 participants 200 participants 200 participants 200 participants 1320 participants
NA [1]  NA [1] 
200
 100.0%
200
 100.0%
200
 100.0%
200
 100.0%
200
 100.0%
200
 100.0%
NA [2] 
[1]
The 2 first groups included subjects for Step 1 alone. The 6 other groups were part of Step 2 alone.
[2]
Total not calculated because data are not available (NA) in one or more arms.
1.Primary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms and Grade 3 Solicited Local Symptoms With Relationship to Vaccination – For Step 1/Cohort 1 Subjects
Hide Description Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). All solicited local symptoms were systematically considered by the investigators as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 symptoms. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time Frame Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title 10PP-HD 1d Group Prevnar13 1d Group
Hide Arm/Group Description:
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
Overall Number of Participants Analyzed 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
0
   0.0%
0
   0.0%
Grade 3 Pain
0
   0.0%
0
   0.0%
Any Redness
0
   0.0%
0
   0.0%
Grade 3 Redness
0
   0.0%
0
   0.0%
Any Swelling
1
   1.7%
0
   0.0%
Grade 3 Swelling
1
   1.7%
0
   0.0%
2.Primary Outcome
Title Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination – For Step 1/Cohort 1 Subjects
Hide Description Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Primary results correspond to results for occurrences of Grade 3 symptoms assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time Frame Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title 10PP-HD 1d Group Prevnar13 1d Group
Hide Arm/Group Description:
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
Overall Number of Participants Analyzed 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
Any Drowsiness
0
   0.0%
0
   0.0%
Grade 3 Drowsiness
0
   0.0%
0
   0.0%
Related Drowsiness
0
   0.0%
0
   0.0%
Grade 3 & Related Drowsiness
0
   0.0%
0
   0.0%
Any Fever
4
   6.7%
2
   3.3%
Grade 3 Fever
0
   0.0%
0
   0.0%
Related Fever
1
   1.7%
1
   1.7%
Grade 3 & Related Fever
0
   0.0%
0
   0.0%
Any Irritability/Fussiness
0
   0.0%
0
   0.0%
Grade 3 Irritability/Fussiness
0
   0.0%
0
   0.0%
Related Irritability/Fussiness
0
   0.0%
0
   0.0%
Grade 3 & Related Irritability/Fussiness
0
   0.0%
0
   0.0%
Any Loss of appetite
1
   1.7%
0
   0.0%
Grade 3 Loss of appetite
0
   0.0%
0
   0.0%
Related Loss of appetite
0
   0.0%
0
   0.0%
Grade 3 & Related Loss of appetite
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects
Hide Description An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of AE, regardless of intensity or relationship to vaccination. Grade 3 = Occurrence of AE which prevented normal activities. Related = Occurrence of AE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 unsolicited AE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time Frame Within the 31-day (Days 0-30) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title 10PP-HD 1d Group Prevnar13 1d Group
Hide Arm/Group Description:
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
Overall Number of Participants Analyzed 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
Any unsolicited AE(s)
13
  21.7%
7
  11.7%
Grade 3 unsolicited AE(s)
0
   0.0%
0
   0.0%
Related unsolicited AE(s)
0
   0.0%
0
   0.0%
Grade 3 and related unsolicited AE(s)
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. Related = Occurrence of an SAE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of SAE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time Frame From Day 0 to Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title 10PP-HD 1d Group Prevnar 13 1d Group
Hide Arm/Group Description:
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
Overall Number of Participants Analyzed 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE(s)
0
   0.0%
0
   0.0%
SAE(s) related to vaccination
0
   0.0%
0
   0.0%
5.Primary Outcome
Title Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx – For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule
Hide Description Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of the isolates.
Time Frame At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title 10PP-LD 3+0d Group 10PP-HD 3+0d Group Synflorix 3+0d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 193 194 196
Measure Type: Count of Participants
Unit of Measure: Participants
1 Mth post dose 3 Number Analyzed 193 participants 194 participants 196 participants
154
  79.8%
137
  70.6%
145
  74.0%
5 Mth post dose 3 Number Analyzed 193 participants 192 participants 194 participants
148
  76.7%
149
  77.6%
159
  82.0%
8 Mth post dose 3 Number Analyzed 189 participants 189 participants 194 participants
151
  79.9%
154
  81.5%
159
  82.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 10PP-LD 3+0d Group, Synflorix 3+0d Group
Comments VE-10PP-LD 3+0d vs Synflorix 3+0d - 1M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Vaccine efficacy (VE) estimated as [(1-Relative Risk (i.e. investigational vaccine over control vaccine))*100] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.
Method of Estimation Estimation Parameter VE
Estimated Value -7.9
Confidence Interval (2-Sided) 95%
-36.3 to 14.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 10PP-LD 3+0d Group, Synflorix 3+0d Group
Comments VE-10PP-LD 3+0d vs Synflorix 3+0d - 5M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Vaccine efficacy (VE) estimated as [(1-Relative Risk (i.e. investigational vaccine over control vaccine))*100] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.
Method of Estimation Estimation Parameter VE
Estimated Value 6.4
Confidence Interval (2-Sided) 95%
-17.8 to 25.7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 10PP-LD 3+0d Group, Synflorix 3+0d Group
Comments VE-10PP-LD 3+0d vs Synflorix 3+0d - 8M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, eight months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Vaccine efficacy (VE) estimated as [(1-Relative Risk (i.e. investigational vaccine over control vaccine))*100] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.
Method of Estimation Estimation Parameter VE
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
-22.6 to 22.5
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 10PP-HD 3+0d Group, Synflorix 3+0d Group
Comments VE-10PP-HD 3+0d vs Synflorix 3+0d - 1M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Vaccine efficacy (VE) estimated as [(1-Relative Risk (i.e. investigational vaccine over control vaccine))*100] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.
Method of Estimation Estimation Parameter VE
Estimated Value 4.5
Confidence Interval (2-Sided) 95%
-21.4 to 25.0
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 10PP-HD 3+0d Group, Synflorix 3+0d Group
Comments VE-10PP-HD 3+0d vs Synflorix 3+0d - 5M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Vaccine efficacy (VE) estimated as [(1-Relative Risk (i.e. investigational vaccine over control vaccine))*100] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.
Method of Estimation Estimation Parameter VE
Estimated Value 5.3
Confidence Interval (2-Sided) 95%
-19.2 to 24.8
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 10PP-HD 3+0d Group, Synflorix 3+0d Group
Comments VE-10PP-HD 3+0d vs Synflorix 3+0d - 8M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, eight months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Vaccine efficacy (VE) estimated as [(1-Relative Risk (i.e. investigational vaccine over control vaccine))*100] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.
Method of Estimation Estimation Parameter VE
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-24.9 to 20.9
Estimation Comments [Not Specified]
6.Primary Outcome
Title Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx – For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule
Hide Description Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of isolates.
Time Frame At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title 10PP-HD 2+1d Group Synflorix 2+1d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 197 197
Measure Type: Count of Participants
Unit of Measure: Participants
1 Mth post dose 2 Number Analyzed 197 participants 197 participants
142
  72.1%
152
  77.2%
5 Mth post dose 2 Number Analyzed 189 participants 194 participants
146
  77.2%
160
  82.5%
3 Mth post dose 3 Number Analyzed 190 participants 193 participants
165
  86.8%
162
  83.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 10PP-HD 2+1d Group, Synflorix 2+1d Group
Comments VE-10PP-HD 2+1d vs Synflorix 2+1d - 1M post-Dose 2. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 2 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Vaccine efficacy (VE) estimated as [(1-Relative Risk (i.e. investigational vaccine over control vaccine))*100] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.
Method of Estimation Estimation Parameter VE (see above)
Estimated Value 6.6
Confidence Interval (2-Sided) 95%
-18.2 to 26.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 10PP-HD 2+1d Group, Synflorix 2+1d Group
Comments VE-10PP-HD 2+1d vs Synflorix 2+1d - 5M post-Dose 2. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 2 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Vaccine efficacy (VE) estimated as [(1-Relative Risk (i.e. investigational vaccine over control vaccine))*100] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.
Method of Estimation Estimation Parameter VE (see above)
Estimated Value 6.3
Confidence Interval (2-Sided) 95%
-18.0 to 25.7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 10PP-HD 2+1d Group, Synflorix 2+1d Group
Comments VE-10PP-HD 2+1d vs Synflorix 2+1d - 3M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, three months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Vaccine efficacy (VE) estimated as [(1-Relative Risk (i.e. investigational vaccine over control vaccine))*100] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.
Method of Estimation Estimation Parameter VE (see above)
Estimated Value -3.5
Confidence Interval (2-Sided) 95%
-29.3 to 17.2
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges – For Cohort 1/Step 1 Subjects
Hide Description Assessed biochemical and haematological parameters were: Haemoglobin (Hgb), White cell count (WBC), Platelet counts, Alanine aminotransferase (ALT) and Creatinine (CREA). Per parameter, it was assessed whether subjects had laboratory values below normal, normal, or above normal range. Below = value below the laboratory reference range defined for the specified time point and laboratory parameter. Within = value within the laboratory reference range defined for the specified time point and laboratory parameter. Above = value above the laboratory reference range defined for the specified time point and laboratory parameter. Unknown = value unknown for the specified time point and laboratory parameter. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time Frame At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title 10PP-HD 1d Group Prevnar 13 1d Group
Hide Arm/Group Description:
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
Overall Number of Participants Analyzed 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
ALT – Status: Unknown
0
   0.0%
0
   0.0%
ALT – Status: Below
0
   0.0%
0
   0.0%
ALT – Status: Within
60
 100.0%
57
  95.0%
ALT – Status: Above
0
   0.0%
3
   5.0%
CREA – Status: Unknown
0
   0.0%
0
   0.0%
CREA – Status: Below
0
   0.0%
0
   0.0%
CREA – Status: Within
60
 100.0%
60
 100.0%
CREA – Status: Above
0
   0.0%
0
   0.0%
Hgb – Status: Unknown
0
   0.0%
0
   0.0%
Hgb – Status: Below
2
   3.3%
2
   3.3%
Hgb – Status: Within
57
  95.0%
56
  93.3%
Hgb – Status: Above
1
   1.7%
2
   3.3%
Platelets – Status: Unknown
0
   0.0%
0
   0.0%
Platelets – Status: Below
0
   0.0%
0
   0.0%
Platelets – Status: Within
59
  98.3%
60
 100.0%
Platelets – Status: Above
1
   1.7%
0
   0.0%
WBC – Status: Unknown
0
   0.0%
0
   0.0%
WBC – Status: Below
0
   0.0%
0
   0.0%
WBC – Status: Within
60
 100.0%
60
 100.0%
WBC – Status: Above
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs) – For Step 1/Cohort 1 Subjects
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time Frame From Day 0 to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title 10PP-HD 1d Group Prevnar 13 1d Group
Hide Arm/Group Description:
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
Overall Number of Participants Analyzed 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – For Cohort 1/Step 1 Subjects
Hide Description Anti-Ply and anti-PhtD antibody concentrations were measured by Multiplex immunoassay and expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 599 LU/mL for anti-Ply antibodies and ≥ 391 LU/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time Frame At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 1d Group Prevnar 13 1d Group
Hide Arm/Group Description:
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
Overall Number of Participants Analyzed 52 51
Geometric Mean (95% Confidence Interval)
Unit of Measure: LU/mL
Anti-Ply
22794.9
(17570.1 to 29573.3)
8510.3
(6668.5 to 10860.8)
Anti-PhtD
31326.3
(26293.9 to 37321.8)
16810.0
(13516.3 to 20906.4)
10.Secondary Outcome
Title Antibody Concentrations Against Protein D (PD) – For Cohort 1/Step 1 Subjects
Hide Description Anti-PD antibody concentrations were measured by Multiplex immunoassay, expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 112 LU/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time Frame At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 1d Group Prevnar 13 1d Group
Hide Arm/Group Description:
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
Overall Number of Participants Analyzed 52 51
Geometric Mean (95% Confidence Interval)
Unit of Measure: LU/mL
137.5
(108.4 to 174.4)
65.1
(58.2 to 72.8)
11.Secondary Outcome
Title Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 1/Step 1 Subjects
Hide Description Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time Frame At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 1d Group Prevnar 13 1d Group
Hide Arm/Group Description:
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
Overall Number of Participants Analyzed 52 51
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Anti-1 antibodies
1.71
(1.33 to 2.22)
3.12
(2.44 to 4.01)
Anti-4 antibodies
4.80
(3.75 to 6.14)
4.17
(3.33 to 5.21)
Anti-5 antibodies
1.17
(0.88 to 1.55)
1.47
(1.08 to 1.99)
Anti-6B antibodies
0.50
(0.34 to 0.73)
1.57
(0.98 to 2.51)
Anti-7F antibodies
2.44
(1.99 to 2.98)
6.11
(4.44 to 8.41)
Anti-9V antibodies
0.89
(0.71 to 1.12)
2.41
(1.87 to 3.26)
Anti-14 antibodies
1.88
(1.39 to 2.53)
3.77
(2.61 to 5.43)
Anti-18C antibodies
7.58
(5.43 to 10.57)
4.82
(3.46 to 6.71)
Anti-19F antibodies
7.82
(5.84 to 10.46)
5.95
(4.48 to 7.90)
Anti-23F antibodies
0.31
(0.21 to 0.46)
1.11
(0.74 to 1.67)
12.Secondary Outcome
Title Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A – For Cohort 1/Step 1 Subjects
Hide Description Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time Frame At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 1d Group Prevnar 13 1d Group
Hide Arm/Group Description:
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
Overall Number of Participants Analyzed 52 51
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Anti-3 antibodies
0.25
(0.14 to 0.46)
2.35
(1.77 to 3.12)
Anti-6A antibodies
0.18
(0.12 to 0.27)
1.36
(0.96 to 1.93)
Anti-19A antibodies
1.38
(0.91 to 2.10)
5.51
(4.02 to 7.55)
13.Secondary Outcome
Title Antibody Concentrations Against Vaccine Serotype 6C – For Cohort 1/Step 1 Subjects
Hide Description No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time Frame At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 1D Group Prevnar13 1D Group
Hide Arm/Group Description:
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 1/Step 1 Subjects
Hide Description The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time Frame At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 1d Prevnar 13 1d Group
Hide Arm/Group Description:
Group This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
Overall Number of Participants Analyzed 52 51
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
OPSONO-1 Number Analyzed 52 participants 50 participants
17.2
(11.2 to 26.4)
112.8
(71.9 to 177.0)
OPSONO-4 Number Analyzed 52 participants 51 participants
2818.9
(2009.7 to 3953.8)
4162.3
(3123.9 to 5545.9)
OPSONO-5 Number Analyzed 52 participants 49 participants
9.0
(6.4 to 12.7)
89.8
(55.8 to 144.5)
OPSONO-6B Number Analyzed 50 participants 51 participants
345.3
(171.4 to 695.5)
5082.5
(3700.2 to 6981.2)
OPSONO-7F Number Analyzed 52 participants 51 participants
6214.0
(5217.1 to 7401.4)
17781.0
(14034.2 to 22528.0)
OPSONO-9V Number Analyzed 52 participants 51 participants
2880.8
(2264.8 to 3664.5)
12687.8
(9188.2 to 17520.2)
OPSONO-14 Number Analyzed 51 participants 51 participants
1116.1
(715.5 to 1741.0)
5985.9
(4313.1 to 8307.4)
OPSONO-18C Number Analyzed 52 participants 49 participants
3955.4
(3027.7 to 5167.2)
2799.8
(1931.1 to 4059.2)
OPSONO-19F Number Analyzed 52 participants 51 participants
862.9
(529.2 to 1407.0)
452.8
(276.2 to 742.2)
OPSONO-23F Number Analyzed 51 participants 51 participants
2756.7
(1638.0 to 4639.5)
12652.4
(8076.0 to 19822.2)
15.Secondary Outcome
Title Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A – For Cohort 1/Step 1 Subjects
Hide Description The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time Frame At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 1d Prevnar 13 1d Group
Hide Arm/Group Description:
Group This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
Overall Number of Participants Analyzed 51 51
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
OPSONO-3 Number Analyzed 51 participants 51 participants
10.1
(6.5 to 15.8)
152.5
(120.4 to 193.2)
OPSONO-6A Number Analyzed 47 participants 51 participants
212.7
(110.4 to 410.0)
8488.8
(5984.2 to 12041.8)
OPSONO-19A Number Analyzed 49 participants 50 participants
461.7
(277.2 to 769.0)
970.3
(701.0 to 1342.9)
16.Secondary Outcome
Title Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C – For Cohort 1/Step 1 Subjects
Hide Description No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time Frame At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 1D Group Prevnar13 1D Group
Hide Arm/Group Description:
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies – For Cohort 1/Step 1 Subjects
Hide Description Concentrations of Hem-Ply antibodies were expressed as geometric mean titers . The cut-off of the assay was an Hem-Ply antibody titer ≥ 140. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time Frame At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 1d Prevnar 13 1d Group
Hide Arm/Group Description:
Group This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
Overall Number of Participants Analyzed 52 51
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
682.3
(562.8 to 827.3)
534.0
(439.4 to 648.9)
18.Secondary Outcome
Title Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Hide Description Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
Time Frame At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-LD 3+0d Group 10PP-HD 3+0d Group Synflorix 3+0d Group Prevnar13 3+0d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 192 195 196 195
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-Ply 1 Mth post dose 3 Number Analyzed 192 participants 195 participants 196 participants 195 participants
13968.86
(12612.27 to 15471.36)
16771.16
(15267.84 to 18422.51)
451.32
(398.68 to 510.91)
419.47
(377.26 to 466.40)
Anti-Ply 5 Mth post dose 3 Number Analyzed 191 participants 192 participants 195 participants 190 participants
11268.35
(9870.36 to 12864.36)
10817.78
(9528.87 to 12281.04)
744.86
(631.27 to 878.89)
637.49
(539.55 to 753.22)
Anti-Ply 8 Mth post dose 3 Number Analyzed 189 participants 190 participants 195 participants 188 participants
10512.39
(9249.03 to 11948.33)
10299.57
(9137.48 to 11609.44)
999.39
(861.41 to 1159.49)
884.83
(748.83 to 1045.54)
Anti-PhtD 1 Mth post dose 3 Number Analyzed 192 participants 195 participants 196 participants 195 participants
2584.28
(2292.67 to 2912.98)
2188.28
(1934.94 to 2474.80)
334.18
(292.90 to 381.28)
486.01
(419.64 to 562.87)
Anti-PhtD 5 Mth post dose 3 Number Analyzed 191 participants 192 participants 195 participants 190 participants
2242.06
(1971.08 to 2550.29)
1498.86
(1311.05 to 1713.57)
936.83
(780.23 to 1124.86)
1419.77
(1196.01 to 1685.40)
Anti-PhtD 8 Mth post dose 3 Number Analyzed 189 participants 190 participants 195 participants 188 participants
2608.78
(2318.09 to 2935.92)
2078.35
(1861.91 to 2319.95)
1667.91
(1432.09 to 1942.55)
2380.09
(2118.18 to 2674.39)
19.Secondary Outcome
Title Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Hide Description Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
Time Frame At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 2+1d Group Synflorix 2+1d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 193 193
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-Ply 1 Mth post dose 2 Number Analyzed 193 participants 193 participants
11491.54
(10168.10 to 12987.23)
488.79
(427.38 to 559.01)
Anti-Ply 5 Mth post dose 2 Number Analyzed 189 participants 191 participants
7453.65
(6460.70 to 8599.21)
807.67
(676.20 to 964.70)
Anti-Ply 3 Mth post dose 3 Number Analyzed 190 participants 190 participants
17933.07
(15867.00 to 20268.17)
1114.25
(945.08 to 1313.71)
Anti-PhtD 1 Mth post dose 2 Number Analyzed 193 participants 193 participants
1264.57
(1103.87 to 1448.66)
368.62
(319.88 to 424.79)
Anti-PhtD 5 Mth post dose 2 Number Analyzed 189 participants 191 participants
1448.08
(1253.08 to 1673.41)
1036.53
(853.80 to 1258.36)
Anti-PhtD 3 Mth post dose 3 Number Analyzed 190 participants 190 participants
3250.91
(2956.18 to 3575.02)
1654.79
(1415.54 to 1934.47)
20.Secondary Outcome
Title Antibody Concentrations Against Protein D (PD) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Hide Description Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
Time Frame At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-LD 3+0d Group 10PP-HD 3+0d Group Synflorix 3+0d Group Prevnar13 3+0d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 191 193 194 189
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PD 1 Mth post dose 3 Number Analyzed 186 participants 193 participants 187 participants 189 participants
1922.8
(1739.3 to 2125.6)
1833.8
(1628.5 to 2065.0)
1990.2
(1765.7 to 2243.3)
84.8
(76.4 to 94.1)
Anti-PD 5 Mth post dose 3 Number Analyzed 191 participants 191 participants 193 participants 185 participants
559.2
(496.8 to 629.6)
499.2
(439.9 to 566.5)
609.9
(537.0 to 692.8)
83.1
(74.9 to 92.2)
Anti-PD 8 Mth post dose 3 Number Analyzed 187 participants 190 participants 194 participants 187 participants
324.3
(282.2 to 372.7)
288.2
(248.5 to 334.2)
344.2
(300.6 to 394.2)
69.2
(63.6 to 75.3)
21.Secondary Outcome
Title Antibody Concentrations Against Protein D (PD) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Hide Description Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
Time Frame At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 2+1d Group Synflorix 2+1d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 190 190
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PD 1 Mth post dose 2 Number Analyzed 187 participants 187 participants
990.9
(869.3 to 1129.5)
1126.7
(999.4 to 1270.2)
Anti-PD 5 Mth post dose 2 Number Analyzed 188 participants 187 participants
281.3
(247.5 to 319.7)
313.0
(276.2 to 354.7)
Anti-PD 3 Mth post dose 3 Number Analyzed 190 participants 190 participants
534.8
(468.9 to 610.0)
664.9
(580.1 to 762.2)
22.Secondary Outcome
Title Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
Hide Description Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
Time Frame At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-LD 3+0d Group 10PP-HD 3+0d Group Synflorix 3+0d Group Prevnar13 3+0d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 191 195 196 195
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Anti-1 1 Mth post dose 3 Number Analyzed 191 participants 194 participants 193 participants 193 participants
3.58
(3.17 to 4.03)
3.20
(2.82 to 3.63)
3.38
(2.98 to 3.83)
5.51
(4.92 to 6.17)
Anti-1 5 Mth post dose 3 Number Analyzed 190 participants 192 participants 195 participants 189 participants
0.67
(0.59 to 0.76)
0.55
(0.49 to 0.63)
0.62
(0.55 to 0.71)
1.16
(1.05 to 1.29)
Anti-1 8 Mth post dose 3 Number Analyzed 189 participants 189 participants 194 participants 187 participants
0.40
(0.35 to 0.45)
0.35
(0.31 to 0.40)
0.40
(0.35 to 0.46)
0.83
(0.73 to 0.93)
Anti-4 1 Mth post dose 3 Number Analyzed 191 participants 195 participants 195 participants 192 participants
3.89
(3.43 to 4.41)
3.15
(2.75 to 3.60)
3.75
(3.29 to 4.28)
6.25
(5.63 to 6.93)
Anti-4 5 Mth post dose 3 Number Analyzed 191 participants 192 participants 194 participants 190 participants
1.19
(1.06 to 1.34)
1.04
(0.93 to 1.16)
1.14
(1.00 to 1.29)
1.06
(0.94 to 1.19)
Anti-4 8 Mth post dose 3 Number Analyzed 189 participants 190 participants 195 participants 188 participants
0.70
(0.62 to 0.79)
0.59
(0.52 to 0.68)
0.66
(0.58 to 0.76)
0.54
(0.48 to 0.61)
Anti-5 1 Mth post dose 3 Number Analyzed 186 participants 193 participants 187 participants 190 participants
5.17
(4.54 to 5.88)
4.83
(4.21 to 5.54)
5.30
(4.66 to 6.02)
7.02
(6.14 to 8.02)
Anti-5 5 Mth post dose 3 Number Analyzed 190 participants 192 participants 194 participants 190 participants
1.37
(1.21 to 1.55)
1.25
(1.10 to 1.43)
1.33
(1.17 to 1.51)
1.79
(1.59 to 2.02)
Anti-5 8 Mth post dose 3 Number Analyzed 189 participants 187 participants 194 participants 187 participants
0.73
(0.65 to 0.83)
0.68
(0.59 to 0.79)
0.69
(0.60 to 0.79)
1.12
(0.99 to 1.27)
Anti-6B 1 Mth post dose 3 Number Analyzed 190 participants 194 participants 192 participants 191 participants
0.91
(0.74 to 1.12)
0.69
(0.56 to 0.86)
1.00
(0.80 to 1.25)
1.35
(1.11 to 1.65)
Anti-6B 5 Mth post dose 3 Number Analyzed 190 participants 190 participants 194 participants 189 participants
1.10
(0.94 to 1.29)
0.86
(0.73 to 1.01)
1.24
(1.06 to 1.44)
0.38
(0.33 to 0.44)
Anti-6B 8 Mth post dose 3 Number Analyzed 189 participants 189 participants 195 participants 188 participants
0.87
(0.75 to 1.00)
0.73
(0.62 to 0.86)
0.96
(0.83 to 1.11)
0.29
(0.26 to 0.34)
Anti-7F 1 Mth post dose 3 Number Analyzed 190 participants 194 participants 195 participants 195 participants
4.63
(4.10 to 5.22)
4.10
(3.62 to 4.63)
4.29
(3.77 to 4.88)
5.53
(4.96 to 6.17)
Anti-7F 5 Mth post dose 3 Number Analyzed 191 participants 192 participants 195 participants 190 participants
2.24
(2.01 to 2.50)
1.84
(1.63 to 2.08)
2.19
(1.95 to 2.47)
2.21
(1.99 to 2.45)
Anti-7F 8 Mth post dose 3 Number Analyzed 189 participants 190 participants 195 participants 188 participants
1.54
(1.38 to 1.72)
1.31
(1.15 to 1.50)
1.57
(1.39 to 1.78)
1.65
(1.49 to 1.82)
Anti-9V 1 Mth post dose 3 Number Analyzed 188 participants 194 participants 196 participants 194 participants
3.23
(2.83 to 3.68)
3.25
(2.83 to 3.72)
3.26
(2.82 to 3.78)
4.02
(3.45 to 4.69)
Anti-9V 5 Mth post dose 3 Number Analyzed 191 participants 192 participants 193 participants 189 participants
1.35
(1.20 to 1.53)
1.15
(1.02 to 1.30)
1.33
(1.17 to 1.52)
0.83
(0.72 to 0.95)
Anti-9V 8 Mth post dose 3 Number Analyzed 189 participants 189 participants 195 participants 188 participants
1.09
(0.95 to 1.25)
0.87
(0.77 to 1.00)
1.08
(0.95 to 1.23)
0.63
(0.55 to 0.73)
Anti-14 1 Mth post dose 3 Number Analyzed 191 participants 193 participants 192 participants 194 participants
4.36
(3.70 to 5.13)
4.11
(3.49 to 4.85)
4.15
(3.52 to 4.89)
4.66
(3.93 to 5.52)
Anti-14 5 Mth post dose 3 Number Analyzed 190 participants 192 participants 194 participants 189 participants
2.15
(1.84 to 2.50)
1.86
(1.56 to 2.22)
2.13
(1.77 to 2.56)
3.43
(2.89 to 4.06)
Anti-14 8 Mth post dose 3 Number Analyzed 189 participants 190 participants 195 participants 188 participants
1.38
(1.18 to 1.61)
1.37
(1.15 to 1.63)
1.42
(1.18 to 1.71)
2.47
(2.10 to 2.92)
Anti-18C 1 Mth post dose 3 Number Analyzed 186 participants 194 participants 189 participants 193 participants
15.88
(13.80 to 18.26)
14.84
(12.88 to 17.09)
15.66
(13.52 to 18.14)
5.78
(5.03 to 6.64)
Anti-18C 5 Mth post dose 3 Number Analyzed 191 participants 192 participants 195 participants 190 participants
4.09
(3.54 to 4.71)
3.52
(3.06 to 4.05)
4.17
(3.60 to 4.83)
0.95
(0.84 to 1.06)
Anti-18C 8 Mth post dose 3 Number Analyzed 189 participants 190 participants 195 participants 188 participants
2.18
(1.90 to 2.51)
1.82
(1.58 to 2.10)
2.24
(1.95 to 2.58)
0.66
(0.58 to 0.75)
Anti-19F 1 Mth post dose 3 Number Analyzed 189 participants 193 participants 193 participants 193 participants
9.47
(8.08 to 11.09)
9.36
(8.04 to 10.91)
10.04
(8.54 to 11.80)
5.99
(5.40 to 6.64)
Anti-19F 5 Mth post dose 3 Number Analyzed 190 participants 191 participants 195 participants 188 participants
2.65
(2.29 to 3.07)
2.34
(2.03 to 2.71)
3.11
(2.67 to 3.62)
0.96
(0.83 to 1.11)
Anti-19F 8 Mth post dose 3 Number Analyzed 189 participants 188 participants 194 participants 187 participants
1.65
(1.40 to 1.93)
1.45
(1.22 to 1.72)
1.99
(1.68 to 2.35)
0.55
(0.46 to 0.66)
Anti-23F 1 Mth post dose 3 Number Analyzed 185 participants 194 participants 189 participants 192 participants
1.18
(0.98 to 1.42)
1.14
(0.95 to 1.38)
1.22
(0.99 to 1.51)
2.92
(2.47 to 3.44)
Anti-23F 5 Mth post dose 3 Number Analyzed 191 participants 192 participants 195 participants 190 participants
0.78
(0.66 to 0.93)
0.77
(0.66 to 0.89)
0.90
(0.77 to 1.06)
0.47
(0.40 to 0.57)
Anti-23F 8 Mth post dose 3 Number Analyzed 189 participants 190 participants 195 participants 188 participants
0.62
(0.53 to 0.73)
0.59
(0.49 to 0.70)
0.68
(0.58 to 0.79)
0.39
(0.31 to 0.48)
23.Secondary Outcome
Title Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
Hide Description Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
Time Frame At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 2+1d Group Synflorix 2+1d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 193 193
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Anti-1 1 Mth post dose 2 Number Analyzed 192 participants 191 participants
2.52
(2.22 to 2.86)
2.41
(2.13 to 2.72)
Anti-1 5 Mth post dose 2 Number Analyzed 189 participants 191 participants
0.44
(0.39 to 0.49)
0.42
(0.37 to 0.48)
Anti-1 3 Mth post dose 3 Number Analyzed 190 participants 190 participants
1.65
(1.43 to 1.90)
1.61
(1.41 to 1.83)
Anti-4 1 Mth post dose 2 Number Analyzed 192 participants 193 participants
2.79
(2.42 to 3.22)
2.67
(2.30 to 3.09)
Anti-4 5 Mth post dose 2 Number Analyzed 189 participants 190 participants
0.79
(0.70 to 0.89)
0.76
(0.67 to 0.86)
Anti-4 3 Mth post dose 3 Number Analyzed 190 participants 190 participants
2.15
(1.91 to 2.42)
1.92
(1.71 to 2.16)
Anti-5 1 Mth post dose 2 Number Analyzed 188 participants 186 participants
3.74
(3.29 to 4.26)
3.40
(2.96 to 3.91)
Anti-5 5 Mth post dose 2 Number Analyzed 188 participants 190 participants
1.07
(0.95 to 1.21)
0.92
(0.81 to 1.04)
Anti-5 3 Mth post dose 3 Number Analyzed 190 participants 190 participants
2.86
(2.53 to 3.23)
2.34
(2.04 to 2.69)
Anti-6B 1 Mth post dose 2 Number Analyzed 189 participants 189 participants
0.51
(0.40 to 0.64)
0.51
(0.41 to 0.64)
Anti-6B 5 Mth post dose 2 Number Analyzed 186 participants 189 participants
0.63
(0.53 to 0.75)
0.67
(0.58 to 0.79)
Anti-6B 3 Mth post dose 3 Number Analyzed 190 participants 190 participants
1.35
(1.17 to 1.56)
1.39
(1.21 to 1.61)
Anti-7F 1 Mth post dose 2 Number Analyzed 192 participants 191 participants
3.29
(2.95 to 3.67)
3.06
(2.68 to 3.49)
Anti-7F 5 Mth post dose 2 Number Analyzed 189 participants 191 participants
1.47
(1.30 to 1.66)
1.48
(1.30 to 1.68)
Anti-7F 3 Mth post dose 3 Number Analyzed 190 participants 190 participants
3.36
(3.00 to 3.77)
3.40
(3.04 to 3.81)
Anti-9V 1 Mth post dose 2 Number Analyzed 191 participants 191 participants
1.85
(1.60 to 2.14)
1.97
(1.72 to 2.26)
Anti-9V 5 Mth post dose 2 Number Analyzed 189 participants 191 participants
0.85
(0.75 to 0.95)
0.81
(0.72 to 0.91)
Anti-9V 3 Mth post dose 3 Number Analyzed 190 participants 190 participants
2.86
(2.54 to 3.23)
2.67
(2.32 to 3.06)
Anti-14 1 Mth post dose 2 Number Analyzed 192 participants 190 participants
2.39
(2.01 to 2.85)
2.29
(1.92 to 2.72)
Anti-14 5 Mth post dose 2 Number Analyzed 189 participants 191 participants
0.85
(0.70 to 1.03)
0.89
(0.75 to 1.06)
Anti-14 3 Mth post dose 3 Number Analyzed 190 participants 189 participants
2.40
(2.07 to 2.79)
2.42
(2.09 to 2.80)
Anti-18C 1 Mth post dose 2 Number Analyzed 191 participants 188 participants
11.33
(9.39 to 13.68)
10.88
(8.98 to 13.18)
Anti-18C 5 Mth post dose 2 Number Analyzed 189 participants 190 participants
3.00
(2.54 to 3.53)
3.18
(2.71 to 3.74)
Anti-18C 3 Mth post dose 3 Number Analyzed 190 participants 190 participants
18.38
(15.94 to 21.19)
16.24
(14.11 to 18.69)
Anti-19F 1 Mth post dose 2 Number Analyzed 193 participants 192 participants
7.33
(6.17 to 8.71)
7.85
(6.61 to 9.32)
Anti-19F 5 Mth post dose 2 Number Analyzed 187 participants 191 participants
2.38
(2.07 to 2.74)
2.48
(2.12 to 2.90)
Anti-19F 3 Mth post dose 3 Number Analyzed 189 participants 189 participants
5.99
(5.13 to 7.01)
6.27
(5.36 to 7.32)
Anti-23F 1 Mth post dose 2 Number Analyzed 189 participants 189 participants
0.63
(0.51 to 0.78)
0.67
(0.53 to 0.84)
Anti-23F 5 Mth post dose 2 Number Analyzed 189 participants 191 participants
0.44
(0.37 to 0.52)
0.46
(0.39 to 0.55)
Anti-23F 3 Mth post dose 3 Number Analyzed 190 participants 190 participants
1.46
(1.24 to 1.72)
1.50
(1.27 to 1.76)
24.Secondary Outcome
Title Antibody Concentrations Against Vaccine Serotypes 3 and 19A – For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
Hide Description Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
Time Frame At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-LD 3+0d Group 10PP-HD 3+0d Group Synflorix 3+0d Group Prevnar13 3+0d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 189 192 195 192
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Anti-3 1 Mth post dose 3 Number Analyzed 184 participants 192 participants 186 participants 192 participants
0.05
(0.04 to 0.06)
0.05
(0.04 to 0.05)
0.05
(0.04 to 0.06)
4.52
(4.15 to 4.92)
Anti-3 5 Mth post dose 3 Number Analyzed 189 participants 192 participants 191 participants 188 participants
0.06
(0.05 to 0.07)
0.06
(0.05 to 0.08)
0.07
(0.06 to 0.09)
0.60
(0.52 to 0.68)
Anti-3 8 Mth post dose 3 Number Analyzed 188 participants 190 participants 195 participants 187 participants
0.08
(0.07 to 0.11)
0.09
(0.07 to 0.12)
0.09
(0.07 to 0.11)
0.32
(0.27 to 0.38)
Anti-19A 1 Mth post dose 3 Number Analyzed 185 participants 190 participants 182 participants 191 participants
0.24
(0.20 to 0.29)
0.20
(0.17 to 0.24)
0.23
(0.19 to 0.27)
5.27
(4.41 to 6.30)
Anti-19A 5 Mth post dose 3 Number Analyzed 187 participants 186 participants 194 participants 187 participants
0.21
(0.17 to 0.25)
0.17
(0.14 to 0.21)
0.24
(0.20 to 0.30)
0.91
(0.76 to 1.08)
Anti-19A 8 Mth post dose 3 Number Analyzed 184 participants 185 participants 192 participants 185 participants
0.24
(0.19 to 0.29)
0.21
(0.17 to 0.27)
0.27
(0.22 to 0.34)
0.64
(0.52 to 0.79)
25.Secondary Outcome
Title Antibody Concentrations Against Vaccine Serotypes 3 and 19A – For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
Hide Description Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
Time Frame At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 2+1d Group Synflorix 2+1d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 190 191
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Anti-3 1 Mth post dose 2 Number Analyzed 186 participants 187 participants
0.04
(0.04 to 0.05)
0.05
(0.04 to 0.06)
Anti-3 5 Mth post dose 2 Number Analyzed 187 participants 191 participants
0.06
(0.05 to 0.07)
0.07
(0.05 to 0.09)
Anti-3 3 Mth post dose 3 Number Analyzed 190 participants 190 participants
0.07
(0.06 to 0.09)
0.08
(0.06 to 0.10)
Anti-19A 1 Mth post dose 2 Number Analyzed 187 participants 186 participants
0.24
(0.20 to 0.29)
0.25
(0.20 to 0.30)
Anti-19A 5 Mth post dose 2 Number Analyzed 183 participants 190 participants
0.18
(0.15 to 0.22)
0.19
(0.15 to 0.24)
Anti-19A 3 Mth post dose 3 Number Analyzed 190 participants 187 participants
0.56
(0.43 to 0.71)
0.64
(0.50 to 0.81)
26.Secondary Outcome
Title Antibody Concentrations Against Vaccine Serotype 6A – For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
Hide Description Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
Time Frame At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-LD 3+0d Group 10PP-HD 3+0d Group Synflorix 3+0d Group Prevnar13 3+0d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 190 192 192 190
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Anti-6A 1Mth post dose 3 Number Analyzed 185 participants 192 participants 187 participants 190 participants
0.13
(0.11 to 0.16)
0.13
(0.11 to 0.15)
0.13
(0.11 to 0.15)
3.01
(2.60 to 3.48)
Anti-6A 5 Mth post dose 3 Number Analyzed 190 participants 190 participants 192 participants 189 participants
0.17
(0.14 to 0.20)
0.15
(0.13 to 0.18)
0.22
(0.18 to 0.27)
1.0
(0.89 to 1.13)
Anti-6A 8 Mth post dose 3 Number Analyzed 177 participants 179 participants 178 participants 148 participants
0.16
(0.14 to 0.19)
0.15
(0.13 to 0.18)
0.18
(0.15 to 0.22)
0.59
(0.51 to 0.68)
27.Secondary Outcome
Title Antibody Concentrations Against Vaccine Serotype 6A – For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
Hide Description Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
Time Frame At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 2+1d Group Synflorix 2+1d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 187 189
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Anti-6A 1 Mth post dose 2 Number Analyzed 187 participants 187 participants
0.11
(0.09 to 0.12)
0.11
(0.09 to 0.13)
Anti-6A 5 Mth post-dose 2 Number Analyzed 185 participants 189 participants
0.10
(0.09 to 0.12)
0.12
(0.10 to 0.14)
Anti-6A 3 Mth post dose 3 Number Analyzed 174 participants 175 participants
0.14
(0.12 to 0.16)
0.15
(0.12 to 0.17)
28.Secondary Outcome
Title Antibody Concentrations Against Vaccine Serotype 6C – For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
Hide Description No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
Time Frame At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-LD 3+0d Group 10PP-HD 3+0d Group Synflorix 3+0d Group Prevnar13 3+0d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
29.Secondary Outcome
Title Antibody Concentrations Against Vaccine Serotype 6C – For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
Hide Description No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
Time Frame At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 2+1D Group Synflorix 2+1D Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
30.Secondary Outcome
Title Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Hide Description The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time Frame At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-LD 3+0d Group 10PP-HD 3+0d Group Synflorix 3+0d Group Prevnar13 3+0d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 93 96 98 96
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
OPSONO-1 1 Mth post dose 3 Number Analyzed 93 participants 96 participants 98 participants 96 participants
136.3
(98.8 to 188.0)
62.7
(42.8 to 91.9)
109.9
(79.2 to 152.6)
161.4
(116.5 to 223.8)
OPSONO-1 5 Mth post dose 3 Number Analyzed 93 participants 95 participants 94 participants 90 participants
14.1
(9.9 to 20.0)
10.1
(7.4 to 13.8)
11.0
(7.9 to 15.3)
14.3
(9.9 to 20.4)
OPSONO-1 8 Mth post dose 3 Number Analyzed 91 participants 95 participants 96 participants 88 participants
10.0
(7.3 to 13.6)
8.4
(6.4 to 11.0)
9.3
(6.9 to 12.5)
12.5
(8.8 to 17.6)
OPSONO-4 1 Mth post dose 3 Number Analyzed 91 participants 95 participants 98 participants 94 participants
835.0
(657.1 to 1061.0)
784.0
(633.1 to 970.8)
715.6
(586.5 to 873.2)
1022.7
(839.6 to 1245.7)
OPSONO-4 5 Mth post dose 3 Number Analyzed 86 participants 91 participants 93 participants 84 participants
86.0
(58.5 to 126.4)
48.2
(31.5 to 73.7)
54.7
(37.2 to 80.4)
62.8
(40.0 to 98.4)
OPSONO-4 8 Mth post dose 3 Number Analyzed 86 participants 90 participants 91 participants 85 participants
48.2
(31.0 to 74.9)
34.3
(21.8 to 53.9)
41.7
(27.4 to 63.7)
41.8
(25.9 to 67.5)
OPSONO-5 1 Mth post dose 3 Number Analyzed 93 participants 95 participants 97 participants 96 participants
97.9
(75.5 to 127.0)
51.4
(37.8 to 70.1)
76.7
(58.5 to 100.6)
91.5
(69.7 to 120.2)
OPSONO-5 5 Mth post dose 3 Number Analyzed 93 participants 96 participants 97 participants 90 participants
19.7
(14.9 to 26.1)
13.1
(10.0 to 17.3)
16.2
(12.1 to 21.5)
17.4
(13.2 to 23.0)
OPSONO-5 8 Mth post dose 3 Number Analyzed 92 participants 95 participants 98 participants 89 participants
9.4
(7.4 to 11.9)
8.3
(6.5 to 10.5)
11.2
(8.7 to 14.2)
10.8
(8.5 to 13.6)
OPSONO-6B 1 Mth post dose 3 Number Analyzed 93 participants 95 participants 96 participants 96 participants
827.6
(601.4 to 1138.9)
432.8
(293.1 to 638.8)
814.6
(594.1 to 1116.9)
1317.6
(937.1 to 1852.6)
OPSONO-6B 5 Mth post dose 3 Number Analyzed 93 participants 91 participants 97 participants 88 participants
242.4
(158.9 to 369.9)
251.3
(169.1 to 373.4)
324.0
(227.2 to 461.9)
90.9
(53.3 to 155.0)
OPSONO-6B 8 Mth post dose 3 Number Analyzed 90 participants 88 participants 97 participants 83 participants
146.9
(95.9 to 225.1)
126.0
(80.4 to 197.4)
233.1
(160.7 to 338.1)
73.7
(43.3 to 125.4)
OPSONO-7F 1 Mth post dose 3 Number Analyzed 93 participants 95 participants 98 participants 96 participants
3755.3
(3060.5 to 4607.9)
2993.3
(2440.1 to 3672.0)
3767.9
(2981.2 to 4762.1)
7241.0
(5923.2 to 8852.1)
OPSONO-7F 5 Mth post dose 3 Number Analyzed 93 participants 96 participants 97 participants 90 participants
2072.1
(1634.8 to 2626.3)
1850.6
(1454.8 to 2354.1)
1710.3
(1329.7 to 2199.9)
3652.1
(2878.1 to 4634.2)
OPSONO-7F 8 Mth post dose 3 Number Analyzed 92 participants 95 participants 98 participants 89 participants
2001.5
(1629.3 to 2458.7)
2313.0
(1851.4 to 2889.8)
2291.2
(1903.9 to 2757.3)
3054.1
(2502.7 to 3727.0)
OPSONO-9V 1 Mth post dose 3 Number Analyzed 93 participants 96 participants 98 participants 94 participants
909.2
(722.3 to 1144.5)
1113.1
(888.0 to 1395.3)
1044.6
(788.6 to 1383.6)
878.3
(647.7 to 1191.0)
OPSONO-9V 5 Mth post dose 3 Number Analyzed 92 participants 95 participants 97 participants 90 participants
360.3
(253.2 to 512.7)
449.2
(347.2 to 581.3)
320.1
(236.2 to 433.6)
342.8
(240.3 to 489.0)
OPSONO-9V 8 Mth post dose 3 Number Analyzed 89 participants 92 participants 97 participants 88 participants
330.6
(230.2 to 474.9)
436.7
(322.5 to 591.4)
277.0
(196.1 to 391.4)
308.6
(216.6 to 439.7)
OPSONO-14 1 Mth post dose 3 Number Analyzed 93 participants 95 participants 97 participants 93 participants
1176.2
(823.1 to 1680.9)
1169.8
(845.3 to 1618.9)
1139.9
(773.2 to 1680.4)
2504.7
(1665.7 to 3766.3)
OPSONO-14 5 Mth post dose 3 Number Analyzed 89 participants 95 participants 95 participants 89 participants
188.9
(129.7 to 275.0)
181.3
(125.6 to 261.5)
233.4
(160.2 to 340.1)
499.3
(350.5 to 711.1)
OPSONO-14 8 Mth post dose 3 Number Analyzed 88 participants 89 participants 95 participants 89 participants
152.9
(103.0 to 227.1)
186.9
(130.5 to 267.6)
223.1
(159.0 to 313.2)
371.0
(257.6 to 534.2)
OPSONO-18C 1 Mth post dose 3 Number Analyzed 93 participants 96 participants 98 participants 94 participants
666.2
(542.9 to 817.6)
532.0
(413.8 to 683.9)
623.6
(493.1 to 788.6)
277.7
(209.9 to 367.5)
OPSONO-18C 5 Mth post dose 3 Number Analyzed 92 participants 95 participants 96 participants 90 participants
39.8
(29.4 to 54.0)
32.0
(22.9 to 44.6)
44.1
(32.7 to 59.5)
9.1
(7.0 to 11.8)
OPSONO-18C 8 Mth post dose 3 Number Analyzed 88 participants 92 participants 97 participants 88 participants
13.6
(10.2 to 18.1)
11.7
(9.0 to 15.1)
16.9
(12.8 to 22.4)
6.5
(5.0 to 8.3)
OPSONO-19F 1 Mth post dose 3 Number Analyzed 90 participants 95 participants 98 participants 94 participants
420.3
(307.6 to 574.2)
340.6
(242.7 to 478.0)
518.3
(389.1 to 690.4)
84.8
(66.1 to 108.9)
OPSONO-19F 5 Mth post dose 3 Number Analyzed 92 participants 96 participants 98 participants 91 participants
47.2
(35.3 to 62.9)
30.7
(22.8 to 41.4)
66.9
(49.3 to 90.9)
7.2
(5.4 to 9.5)
OPSONO-19F 8 Mth post dose 3 Number Analyzed 92 participants 94 participants 97 participants 89 participants
22.0
(16.3 to 29.6)
20.3
(14.6 to 28.5)
32.5
(23.6 to 44.7)
7.0
(5.4 to 9.2)
OPSONO-23F 1 Mth post dose 3 Number Analyzed 93 participants 94 participants 98 participants 96 participants
1421.3
(976.4 to 2068.9)
965.1
(622.7 to 1495.8)
1030.2
(693.0 to 1531.4)
2821.9
(1913.1 to 4162.3)
OPSONO-23F 5 Mth post dose 3 Number Analyzed 85 participants 87 participants 90 participants 86 participants
307.4
(183.0 to 516.3)
387.1
(234.4 to 639.1)
239.5
(140.2 to 409.1)
638.6
(369.2 to 1104.6)
OPSONO-23F 8 Mth post dose 3 Number Analyzed 87 participants 81 participants 89 participants 83 participants
306.2
(172.3 to 543.9)
385.9
(221.1 to 673.5)
410.8
(246.7 to 684.2)
650.4
(367.1 to 1152.3)
31.Secondary Outcome
Title Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Hide Description The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time Frame At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 2+1d Group Synflorix 2+1d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 98 97
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
OPSONO-1 1 Mth post dose 2 Number Analyzed 98 participants 97 participants
67.3
(46.5 to 97.4)
58.0
(40.4 to 83.4)
OPSONO-1 5 Mth post dose 2 Number Analyzed 95 participants 95 participants
7.7
(6.0 to 9.8)
8.1
(6.1 to 10.7)
OPSONO-1 3 Mth post dose 3 Number Analyzed 95 participants 95 participants
58.8
(38.2 to 90.7)
57.5
(37.8 to 87.5)
OPSONO-4 1 Mth post dose 2 Number Analyzed 97 participants 96 participants
461.9
(377.9 to 564.5)
427.2
(327.0 to 558.0)
OPSONO-4 5 Mth post dose 2 Number Analyzed 92 participants 90 participants
27.0
(18.6 to 39.2)
27.4
(18.6 to 40.4)
OPSONO-4 3 Mth post dose 3 Number Analyzed 93 participants 91 participants
260.0
(190.0 to 355.8)
241.1
(170.4 to 341.0)
OPSONO-5 1 Mth post dose 2 Number Analyzed 98 participants 97 participants
49.1
(37.0 to 65.0)
49.1
(36.2 to 66.6)
OPSONO-5 5 Mth post dose 2 Number Analyzed 95 participants 95 participants
11.8
(9.3 to 15.1)
12.6
(9.7 to 16.4)
OPSONO-5 3 Mth post dose 3 Number Analyzed 96 participants 95 participants
58.2
(44.0 to 77.0)
47.0
(34.4 to 64.2)
OPSONO-6B 1 Mth post dose 2 Number Analyzed 95 participants 96 participants
359.8
(240.2 to 539.0)
331.7
(223.1 to 493.2)
OPSONO-6B 5 Mth post dose 2 Number Analyzed 91 participants 91 participants
159.1
(102.0 to 248.0)
111.1
(68.3 to 180.7)
OPSONO-6B 3 Mth post dose 3 Number Analyzed 94 participants 89 participants
214.7
(146.2 to 315.1)
192.0
(130.0 to 283.6)
OPSONO-7F 1 Mth post dose 2 Number Analyzed 98 participants 96 participants
2643.3
(2122.6 to 3291.6)
2336.3
(1923.9 to 2837.3)
OPSONO-7F 5 Mth post dose 2 Number Analyzed 95 participants 94 participants
1258.2
(972.6 to 1627.6)
1466.4
(1150.1 to 1869.7)
OPSONO-7F 3 Mth post dose 3 Number Analyzed 96 participants 95 participants
2767.6
(2261.7 to 3386.7)
2963.6
(2379.0 to 3691.9)
OPSONO-9V 1 Mth post dose 2 Number Analyzed 98 participants 96 participants
783.7
(609.0 to 1008.5)
763.2
(625.4 to 931.4)
OPSONO-9V 5 Mth post dose 2 Number Analyzed 91 participants 94 participants
241.3
(159.0 to 366.2)
163.3
(113.8 to 234.3)
OPSONO-9V 3 Mth post dose 3 Number Analyzed 95 participants 95 participants
1044.3
(818.8 to 1332.0)
712.4
(534.2 to 950.0)
OPSONO-14 1 Mth post dose 2 Number Analyzed 98 participants 96 participants
349.7
(231.7 to 527.8)
310.5
(200.1 to 481.9)
OPSONO-14 5 Mth post dose 2 Number Analyzed 89 participants 91 participants
54.3
(35.5 to 83.0)
40.2
(26.6 to 60.8)
OPSONO-14 3 Mth post dose 3 Number Analyzed 93 participants 93 participants
335.9
(257.2 to 438.7)
254.6
(180.4 to 359.4)
OPSONO-18C 1 Mth post dose 2 Number Analyzed 98 participants 97 participants
464.7
(317.0 to 681.2)
459.7
(330.7 to 639.1)
OPSONO-18C 5 Mth post dose 2 Number Analyzed 93 participants 95 participants
28.4
(20.3 to 39.7)
33.6
(23.5 to 47.8)
OPSONO-18C 3 Mth post dose 3 Number Analyzed 96 participants 94 participants
562.8
(405.0 to 782.0)
522.0
(390.0 to 698.7)
OPSONO-19F 1 Mth post dose 2 Number Analyzed 96 participants 96 participants
299.3
(213.5 to 419.6)
284.7
(201.1 to 403.1)
OPSONO-19F 5 Mth post dose 2 Number Analyzed 93 participants 94 participants
35.5
(26.0 to 48.3)
38.7
(27.6 to 54.3)
OPSONO-19F 3 Mth post dose 3 Number Analyzed 96 participants 95 participants
203.6
(140.5 to 295.1)
168.1
(110.0 to 256.8)
OPSONO-23F 1 Mth post dose 2 Number Analyzed 94 participants 95 participants
539.6
(343.1 to 848.6)
493.9
(308.8 to 789.8)
OPSONO-23F 5 Mth post dose 2 Number Analyzed 90 participants 91 participants
156.5
(88.7 to 276.3)
158.6
(91.1 to 276.1)
OPSONO-23F 3 Mth post dose 3 Number Analyzed 95 participants 91 participants
612.2
(395.6 to 947.4)
835.7
(548.1 to 1274.1)
32.Secondary Outcome
Title Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Hide Description The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time Frame At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-LD 3+0d Group 10PP-HD 3+0d Group Synflorix 3+0d Group Prevnar13 3+0d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 92 94 97 96
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
OPSONO-3 1 Mth post dose 3 Number Analyzed 92 participants 92 participants 97 participants 96 participants
5.3
(4.3 to 6.4)
4.5
(4.0 to 5.1)
4.8
(4.2 to 5.5)
98.3
(82.8 to 116.7)
OPSONO-3 5 Mth post dose 3 Number Analyzed 91 participants 94 participants 94 participants 89 participants
7.1
(5.6 to 9.0)
5.5
(4.5 to 6.6)
6.7
(5.3 to 8.5)
15.1
(11.0 to 20.6)
OPSONO-3 8 Mth post dose 3 Number Analyzed 86 participants 91 participants 95 participants 87 participants
8.1
(6.3 to 10.5)
8.3
(6.3 to 11.0)
7.8
(6.1 to 10.1)
12.3
(9.0 to 16.7)
OPSONO-6A 1 Mth post dose 3 Number Analyzed 88 participants 91 participants 96 participants 96 participants
13.7
(9.0 to 20.9)
11.8
(8.0 to 17.4)
11.3
(7.7 to 16.5)
2770.0
(2216.1 to 3462.4)
OPSONO-6A 5 Mth post dose 3 Number Analyzed 92 participants 92 participants 94 participants 88 participants
14.8
(9.5 to 23.2)
12.0
(8.0 to 17.9)
20.2
(12.7 to 32.0)
602.0
(433.4 to 836.2)
OPSONO-6A 8 Mth post dose 3 Number Analyzed 86 participants 86 participants 88 participants 87 participants
14.8
(9.4 to 23.3)
12.4
(8.1 to 19.1)
18.5
(11.7 to 29.3)
260.1
(167.4 to 404.2)
33.Secondary Outcome
Title Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Hide Description The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time Frame At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 2+1d Group Synflorix 2+1d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 96 97
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
OPSONO-3 1 Mth post dose 2 Number Analyzed 96 participants 97 participants
4.7
(4.2 to 5.4)
5.1
(4.2 to 6.1)
OPSONO-3 5 Mth post dose 2 Number Analyzed 87 participants 86 participants
5.9
(4.8 to 7.3)
5.9
(4.6 to 7.6)
OPSONO-3 3 Mth post dose 3 Number Analyzed 92 participants 93 participants
7.4
(5.7 to 9.6)
6.8
(5.4 to 8.4)
OPSONO-6A 1 Mth post dose 2 Number Analyzed 96 participants 97 participants
6.7
(5.1 to 8.8)
6.7
(5.1 to 8.7)
OPSONO-6A 5 Mth post dose 2 Number Analyzed 93 participants 95 participants
12.4
(8.4 to 18.3)
12.2
(8.2 to 18.3)
OPSONO-6A 3 Mth post dose 3 Number Analyzed 88 participants 91 participants
12.6
(8.3 to 19.2)
10.0
(6.7 to 15.0)
34.Secondary Outcome
Title Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Hide Description The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) to the serotype-specific Lower Limit of Quantification ( = 143). This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time Frame At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-LD 3+0d Group 10PP-HD 3+0d Group Synflorix 3+0d Group Prevnar13 3+0d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 71 79 71 89
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
OPSONO-19A 1 Mth post dose 3 Number Analyzed 70 participants 72 participants 71 participants 89 participants
347.0
(238.0 to 505.9)
281.1
(192.8 to 409.8)
369.8
(257.5 to 531.0)
2652.8
(2277.5 to 3089.9)
OPSONO-19A 5 Mth post dose 3 Number Analyzed 71 participants 75 participants 61 participants 69 participants
120.4
(91.9 to 157.8)
121.6
(94.3 to 156.8)
140.2
(102.1 to 192.4)
704.2
(498.5 to 994.8)
OPSONO-19A 8 Mth post dose 3 Number Analyzed 67 participants 79 participants 69 participants 60 participants
155.2
(109.1 to 220.9)
151.5
(110.0 to 208.7)
138.7
(101.3 to 190.0)
394.4
(261.8 to 594.2)
35.Secondary Outcome
Title Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Hide Description The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) to the serotype-specific Lower Limit of Quantification ( = 143). This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time Frame At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 2+1d Group Synflorix 2+1d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 72 81
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
OPSONO-19A 1 Mth post dose 2 Number Analyzed 69 participants 71 participants
231.3
(164.5 to 325.4)
177.4
(129.4 to 243.2)
OPSONO-19A 5 Mth post dose 2 Number Analyzed 67 participants 81 participants
99.1
(80.0 to 122.7)
107.4
(84.5 to 136.5)
OPSONO-19A 3 Mth post dose 3 Number Analyzed 72 participants 79 participants
274.2
(187.6 to 400.8)
361.2
(247.5 to 527.2)
36.Secondary Outcome
Title Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Hide Description No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
Time Frame At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-LD 3+0d Group 10PP-HD 3+0d Group Synflorix 3+0d Group Prevnar13 3+0d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
37.Secondary Outcome
Title Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Hide Description No analysis was performed on opsonophagocytic activity for Antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
Time Frame At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 2+1D Group Synflorix 2+1D Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
38.Secondary Outcome
Title Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Hide Description The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time Frame At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-LD 3+0d Group 10PP-HD 3+0d Group Synflorix 3+0d Group Prevnar13 3+0d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
39.Secondary Outcome
Title Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Hide Description The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time Frame At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 2+1D Group Synflorix 2+1D Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
40.Secondary Outcome
Title Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Hide Description This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.
Time Frame At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-LD 3+0d Group 10PP-HD 3+0d Group Synflorix 3+0d Group Prevnar13 3+0d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 99 99 98 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-D 1 Mth post dose 3
2.499
(2.111 to 2.959)
2.696
(2.381 to 3.053)
2.874
(2.524 to 3.272)
1.531
(1.330 to 1.762)
Anti-T 1 Mth post dose 3
4.977
(4.127 to 6.002)
5.113
(4.294 to 6.089)
4.709
(3.994 to 5.551)
4.047
(3.462 to 4.731)
41.Secondary Outcome
Title Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Hide Description This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.
Time Frame At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 2+1d Group Synflorix 2+1d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 95 96
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-D 1 Mth post dose 2
2.591
(2.213 to 3.033)
2.560
(2.207 to 2.969)
Anti-T 1 Mth post dose 2
5.714
(4.816 to 6.781)
4.738
(3.905 to 5.749)
42.Secondary Outcome
Title Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Hide Description This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.
Time Frame At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-LD 3+0d Group 10PP-HD 3+0d Group Synflorix 3+0d Group Prevnar13 3+0d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 99 99 98 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
111.9
(99.4 to 125.8)
110.3
(99.3 to 122.5)
105.8
(94.4 to 118.6)
117.0
(105.0 to 130.3)
43.Secondary Outcome
Title Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Hide Description This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.
Time Frame At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 2+1d Group Synflorix 2+1d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 94 96
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
123.2
(112.0 to 135.5)
114.7
(101.3 to 129.9)
44.Secondary Outcome
Title Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Hide Description This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.
Time Frame At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-LD 3+0d Group 10PP-HD 3+0d Group Synflorix 3+0d Group Prevnar13 3+0d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 99 99 98 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
23.381
(19.326 to 28.287)
19.397
(15.319 to 24.561)
19.239
(15.085 to 24.537)
18.981
(15.244 to 23.635)
45.Secondary Outcome
Title Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Hide Description This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.
Time Frame At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 2+1d Group Synflorix 2+1d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 95 96
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
21.274
(17.909 to 25.272)
21.150
(17.427 to 25.669)
46.Secondary Outcome
Title Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Hide Description This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.
Time Frame At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-LD 3+0d Group 10PP-HD 3+0d Group Synflorix 3+0d Group Prevnar13 3+0d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 94 93 91 89
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
1235.8
(946.9 to 1612.9)
1165.8
(910.7 to 1492.3)
990.1
(757.6 to 1294.0)
1206.6
(946.2 to 1538.7)
47.Secondary Outcome
Title Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Hide Description This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.
Time Frame At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-HD 2+1d Group Synflorix 2+1d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 89 88
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
1318.5
(1062.5 to 1636.3)
976.5
(724.2 to 1316.8)
48.Secondary Outcome
Title Antibody Titers Against Poliovirus 1, 2 and 3 (Anti-Polio, Anti-Polio 2 and Anti-Polio 3) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Hide Description This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8.
Time Frame At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title 10PP-LD 3+0d Group 10PP-HD 3+0d Group Synflorix 3+0d Group Prevnar13 3+0d Group
Hide Arm/Group Description:
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Overall Number of Participants Analyzed 97 92 91 94
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Polio 1 - 1 Mth post dose 3 Number Analyzed 97 participants 92 participants 91 participants 94 participants
413.2
(287.0 to 594.9)
314.8
(202.7 to 488.7)
447.9
(278.5 to 720.1)
398.3
(256.6 to 618.3)
Anti-Polio 2 - 1 Mth post dose 3 Number Analyzed 76 participants 78 participants 76 participants 73 participants