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Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine.

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ClinicalTrials.gov Identifier: NCT00370396
Recruitment Status : Completed
First Posted : August 31, 2006
Results First Posted : November 26, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Primary Purpose: Prevention
Condition Infections, Streptococcal
Interventions Biological: Synflorix
Biological: Prevenar
Biological: Infanrix hexa
Enrollment 1200

Recruitment Details This study consisted of approximately 1200 subjects who were previously enrolled and had been vaccinated with either the 10Pn or 7Pn vaccine as part of the 10PN-PD-DIT-001 (105553) study (EudraCTnumber: 2005-003300-11).
Pre-assignment Details During the screening the following was performed: informed consent was obtained and signed from parents or guardians of subjects, check for inclusion/exclusion criteria and contraindications/precautions was performed, and medical history of subjects was collected. Prior to vaccination, subjects’ pre-vaccination body temperature was evaluated.
Arm/Group Title Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Hide Arm/Group Description This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid. This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid. This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
Period Title: Overall Study
Started [1] 737 92 283
Completed 726 91 282
Not Completed 11 1 1
Reason Not Completed
Withdrawal by Subject             0             0             1
Lost to Follow-up             11             1             0
[1]
1112 subjects were vaccinated in current study out of 1200 who received at least 1 dose of Prevenar
Arm/Group Title Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group Total
Hide Arm/Group Description This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid. This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid. This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid. Total of all reporting groups
Overall Number of Baseline Participants 737 92 283 1112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 737 participants 92 participants 283 participants 1112 participants
15.3  (2.08) 14.2  (2.26) 14.2  (2.23) 14.93  (2.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 737 participants 92 participants 283 participants 1112 participants
Female
360
  48.8%
50
  54.3%
134
  47.3%
544
  48.9%
Male
377
  51.2%
42
  45.7%
149
  52.7%
568
  51.1%
1.Primary Outcome
Title Number of Subjects With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) Post Booster Between the Synflorix-Synflorix and Prevenar-Prevenar Groups
Hide Description Fever was measured as rectal temperature. Assessment of occurrences of rectal temperature > 39.0 °C was performed post administration of the booster dose of pneumococcal vaccine (Synflorix™ or Prevenar™ vaccine) in this study. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available.
Time Frame Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects, who completed their symptom sheets.
Arm/Group Title Synflorix-Synflorix Group Prevenar-Prevenar Group
Hide Arm/Group Description:
This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
Overall Number of Participants Analyzed 735 91
Measure Type: Count of Participants
Unit of Measure: Participants
24
   3.3%
7
   7.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Synflorix-Synflorix Group, Prevenar-Prevenar Group
Comments Analysis aimed at demonstrating the non-inferiority of Synflorix™ vs Prevenar™ vaccine, both co-administered with Infanrix hexa™ vaccine, in terms of post-immunization febrile reactions with rectal fever > 39.0°C.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Standardized asymptotic 95% confidence interval (CI) for the difference [Synflorix-Synflorix minus Prevenar-Prevenar] in terms of percentages of subjects reporting rectal fever >39.0°C was computed.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -4.43
Confidence Interval (2-Sided) 95%
-11.85 to -0.21
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available.
Time Frame Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects, who completed their symptom sheets..
Arm/Group Title Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Hide Arm/Group Description:
This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
Overall Number of Participants Analyzed 735 91 282
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
452
  61.5%
48
  52.7%
150
  53.2%
Grade 3 Pain
47
   6.4%
3
   3.3%
18
   6.4%
Any Swelling
338
  46.0%
42
  46.2%
112
  39.7%
Grade 3 Swelling
67
   9.1%
7
   7.7%
20
   7.1%
Any Redness
451
  61.4%
59
  64.8%
153
  54.3%
Grade 3 Redness
96
  13.1%
7
   7.7%
19
   6.7%
3.Secondary Outcome
Title Number of Subjects With Any and Any Grade 3 Solicited General Symptoms
Hide Description Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal everyday activities. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available.
Time Frame Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects, who completed their symptom sheets..
Arm/Group Title Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Hide Arm/Group Description:
This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
Overall Number of Participants Analyzed 735 91 282
Measure Type: Count of Participants
Unit of Measure: Participants
Any drowsiness
303
  41.2%
48
  52.7%
130
  46.1%
Grade 3 drowsiness
5
   0.7%
0
   0.0%
5
   1.8%
Any fever
245
  33.3%
33
  36.3%
112
  39.7%
Grade 3 fever
1
   0.1%
2
   2.2%
3
   1.1%
Any irritability
438
  59.6%
55
  60.4%
176
  62.4%
Grade 3 irritability
15
   2.0%
2
   2.2%
12
   4.3%
Any loss of appetite
230
  31.3%
31
  34.1%
92
  32.6%
Grade 3 loss of appetite
4
   0.5%
0
   0.0%
3
   1.1%
4.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs)
Hide Description An 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. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007.
Time Frame Within 31 days (Day 0-30) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects.
Arm/Group Title Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Hide Arm/Group Description:
This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
Overall Number of Participants Analyzed 737 92 283
Measure Type: Count of Participants
Unit of Measure: Participants
188
  25.5%
32
  34.8%
99
  35.0%
5.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs) During the Active Phase of the Study
Hide Description An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. “Any” is defined an incidence of a SAE regardless of intensity/severity . The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007.
Time Frame Throughout the Active Phase of the study, that is, within 31 days (Day 0-30) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects.
Arm/Group Title Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Hide Arm/Group Description:
This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
Overall Number of Participants Analyzed 737 92 283
Measure Type: Count of Participants
Unit of Measure: Participants
12
   1.6%
1
   1.1%
4
   1.4%
6.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs) During the Entire Study
Hide Description An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. “Any” is defined an incidence of a SAE regardless of intensity/severity. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects enrolled in the ESFU Phase of the study.
Time Frame Throughout the study period, from Month 0 prior to booster vaccination up to Month 6, end of the ESFU in this study 10PN-PD-DIT-007
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects.
Arm/Group Title Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Hide Arm/Group Description:
This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
Overall Number of Participants Analyzed 726 92 282
Measure Type: Count of Participants
Unit of Measure: Participants
33
   4.5%
6
   6.5%
8
   2.8%
7.Secondary Outcome
Title Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens – by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA)
Hide Description A seroprotected subject as regards anti-pneumococcal serotype antibody was defined as a subject with anti-pneumococcal serotype antibody concentration above than or equal to (≥) 0.20 microgram per millilitre (μg/mL). Anti-pneumococcal serotypes antibodies assessed were antibodies against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F). Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using ≥ 0.05 μg/mL as seropositivity cut off. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Time Frame Prior to (PRE) and one month after (Month 1) booster vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Arm/Group Title Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Hide Arm/Group Description:
This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
Overall Number of Participants Analyzed 347 89 134
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-1 PRE Number Analyzed 338 participants 82 participants 133 participants
123
  36.4%
3
   3.7%
3
   2.3%
Anti-1 Month 1 Number Analyzed 342 participants 81 participants 133 participants
340
  99.4%
4
   4.9%
113
  85.0%
Anti-4 PRE Number Analyzed 342 participants 78 participants 131 participants
196
  57.3%
53
  67.9%
99
  75.6%
Anti-4 Month 1 Number Analyzed 343 participants 88 participants 133 participants
342
  99.7%
88
 100.0%
133
 100.0%
Anti-5 PRE Number Analyzed 344 participants 84 participants 134 participants
231
  67.2%
5
   6.0%
14
  10.4%
Anti-5 Month 1 Number Analyzed 342 participants 82 participants 133 participants
340
  99.4%
5
   6.1%
114
  85.7%
Anti-6B PRE Number Analyzed 333 participants 75 participants 131 participants
223
  67.0%
23
  30.7%
69
  52.7%
Anti-6B Month 1 Number Analyzed 341 participants 87 participants 133 participants
329
  96.5%
85
  97.7%
131
  98.5%
Anti-7F PRE Number Analyzed 340 participants 85 participants 133 participants
308
  90.6%
4
   4.7%
3
   2.3%
Anti-7F Month 1 Number Analyzed 342 participants 85 participants 133 participants
342
 100.0%
6
   7.1%
127
  95.5%
Anti-9V PRE Number Analyzed 344 participants 77 participants 130 participants
291
  84.6%
70
  90.9%
123
  94.6%
Anti-9V Month 1 Number Analyzed 340 participants 89 participants 133 participants
340
 100.0%
89
 100.0%
133
 100.0%
Anti-14 PRE Number Analyzed 336 participants 75 participants 130 participants
268
  79.8%
70
  93.3%
125
  96.2%
Anti-14 Month 1 Number Analyzed 339 participants 86 participants 133 participants
336
  99.1%
86
 100.0%
133
 100.0%
Anti-18C PRE Number Analyzed 341 participants 83 participants 131 participants
240
  70.4%
60
  72.3%
107
  81.7%
Anti-18C Month 1 Number Analyzed 343 participants 87 participants 134 participants
343
 100.0%
87
 100.0%
133
  99.3%
Anti-19F PRE Number Analyzed 347 participants 85 participants 134 participants
272
  78.4%
38
  44.7%
76
  56.7%
Anti-19F Month 1 Number Analyzed 343 participants 87 participants 134 participants
341
  99.4%
87
 100.0%
131
  97.8%
Anti-23F PRE Number Analyzed 338 participants 77 participants 130 participants
206
  60.9%
43
  55.8%
98
  75.4%
Anti-23F Month 1 Number Analyzed 341 participants 88 participants 132 participants
332
  97.4%
87
  98.9%
128
  97.0%
8.Secondary Outcome
Title Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) – by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA)
Hide Description Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean concentrations (GMCs), in microgram per millilitre (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 µg/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Time Frame Prior to (PRE) and one month (Month 1) post booster vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Arm/Group Title Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Hide Arm/Group Description:
This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
Overall Number of Participants Analyzed 347 89 134
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Anti-1 PRE Number Analyzed 338 participants 82 participants 133 participants
0.14
(0.13 to 0.16)
0.03
(0.03 to 0.04)
0.03
(0.03 to 0.04)
Anti-1 Month 1 Number Analyzed 342 participants 81 participants 133 participants
1.53
(1.4 to 1.68)
0.04
(0.03 to 0.05)
0.67
(0.56 to 0.8)
Anti-4 PRE Number Analyzed 342 participants 78 participants 131 participants
0.23
(0.21 to 0.26)
0.3
(0.25 to 0.37)
0.35
(0.3 to 0.41)
Anti-4 Month 1 Number Analyzed 343 participants 88 participants 133 participants
3.35
(3.06 to 3.67)
4.4
(3.75 to 5.15)
4.47
(3.85 to 5.19)
Anti-5 PRE Number Analyzed 344 participants 84 participants 134 participants
0.27
(0.25 to 0.3)
0.04
(0.04 to 0.05)
0.05
(0.04 to 0.05)
Anti-5 Month 1 Number Analyzed 342 participants 82 participants 133 participants
2.2
(2 to 2.42)
0.05
(0.04 to 0.07)
0.74
(0.6 to 0.9)
Anti-6B PRE Number Analyzed 333 participants 75 participants 131 participants
0.31
(0.27 to 0.35)
0.14
(0.11 to 0.19)
0.26
(0.2 to 0.33)
Anti-6B Month 1 Number Analyzed 341 participants 87 participants 133 participants
1.94
(1.74 to 2.17)
3.53
(2.83 to 4.41)
1.74
(1.48 to 2.05)
Anti-7F PRE Number Analyzed 340 participants 85 participants 133 participants
0.57
(0.52 to 0.62)
0.03
(0.03 to 0.04)
0.03
(0.03 to 0.03)
Anti-7F Month 1 Number Analyzed 342 participants 85 participants 133 participants
3.5
(3.25 to 3.76)
0.04
(0.03 to 0.05)
1.83
(1.49 to 2.24)
Anti-9V PRE Number Analyzed 344 participants 77 participants 130 participants
0.54
(0.48 to 0.6)
0.62
(0.51 to 0.76)
0.78
(0.68 to 0.89)
Anti-9V Month 1 Number Analyzed 340 participants 89 participants 133 participants
3.25
(2.99 to 3.53)
6.09
(5.19 to 7.15)
1.94
(1.73 to 2.19)
Anti-14 PRE Number Analyzed 336 participants 75 participants 130 participants
0.66
(0.56 to 0.76)
1.06
(0.82 to 1.38)
1.69
(1.4 to 2.03)
Anti-14 Month 1 Number Analyzed 339 participants 86 participants 133 participants
5.56
(5.01 to 6.18)
9.29
(7.85 to 10.99)
4.76
(4.12 to 5.49)
Anti-18C PRE Number Analyzed 341 participants 83 participants 131 participants
0.3
(0.28 to 0.34)
0.32
(0.26 to 0.39)
0.37
(0.32 to 0.43)
Anti-18C Month 1 Number Analyzed 343 participants 87 participants 134 participants
5.01
(4.6 to 5.46)
5.21
(4.44 to 6.11)
4.98
(4.17 to 5.93)
Anti-19F PRE Number Analyzed 347 participants 85 participants 134 participants
0.53
(0.46 to 0.61)
0.23
(0.17 to 0.31)
0.31
(0.24 to 0.41)
Anti-19F Month 1 Number Analyzed 343 participants 87 participants 134 participants
6.05
(5.46 to 6.71)
3.35
(2.83 to 3.97)
5.06
(4.24 to 6.04)
Anti-23F PRE Number Analyzed 338 participants 77 participants 130 participants
0.27
(0.23 to 0.31)
0.24
(0.19 to 0.31)
0.4
(0.3 to 0.5)
Anti-23F Month 1 Number Analyzed 341 participants 88 participants 132 participants
2.38
(2.13 to 2.66)
6.67
(5.38 to 8.26)
2.42
(1.99 to 2.95)
9.Secondary Outcome
Title Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Hide Description OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMT calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Time Frame Prior to (PRE) and one month (Month 1) post booster vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Arm/Group Title Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Hide Arm/Group Description:
This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
Overall Number of Participants Analyzed 326 83 126
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Opsono-1 PRE Number Analyzed 326 participants 83 participants 126 participants
6.1
(5.4 to 6.9)
5
(4.1 to 6)
4.9
(4.2 to 5.8)
Opsono-1 Month 1 Number Analyzed 301 participants 83 participants 121 participants
192.2
(157.5 to 234.6)
4.3
(3.9 to 4.7)
8.3
(6.7 to 10.4)
Opsono-4 PRE Number Analyzed 295 participants 79 participants 112 participants
20.3
(16.2 to 25.5)
24.5
(15.4 to 38.8)
37.8
(24.8 to 57.7)
Opsono-4 Month 1 Number Analyzed 297 participants 81 participants 123 participants
1856.3
(1666.1 to 2068)
2812.6
(2282.5 to 3465.9)
1528.9
(1286.9 to 1817)
Opsono-5 PRE Number Analyzed 305 participants 79 participants 124 participants
8.2
(7.2 to 9.4)
4.4
(3.9 to 4.9)
4.1
(3.9 to 4.3)
Opsono-5 Month 1 Number Analyzed 299 participants 83 participants 122 participants
144.1
(122.1 to 170)
4.1
(3.9 to 4.4)
9.5
(7.5 to 11.9)
Opsono-6B PRE Number Analyzed 284 participants 75 participants 120 participants
60.3
(44.6 to 81.7)
51.4
(27.1 to 97.5)
36.7
(23.3 to 57.7)
Opsono-6B Month 1 Number Analyzed 295 participants 79 participants 118 participants
981.2
(830.7 to 1159.1)
3459.6
(2535.7 to 4720.3)
640.2
(480.7 to 852.7)
Opsono-7F PRE Number Analyzed 294 participants 76 participants 117 participants
377.7
(279.8 to 509.9)
34.8
(17.5 to 69.3)
25.3
(15.4 to 41.6)
Opsono-7F Month 1 Number Analyzed 296 participants 74 participants 118 participants
4330.3
(3836 to 4888.3)
25.2
(13.1 to 48.7)
2397.2
(1929.2 to 2978.7)
Opsono-9V PRE Number Analyzed 309 participants 81 participants 122 participants
296.9
(259.3 to 339.9)
305.5
(227.1 to 411)
305.1
(248.7 to 374.4)
Opsono-9V Month 1 Number Analyzed 297 participants 79 participants 120 participants
2343.5
(2097.1 to 2618.7)
5357.4
(4212.5 to 6813.6)
886.8
(747.7 to 1051.8)
Opsono-14 PRE Number Analyzed 299 participants 79 participants 118 participants
188.1
(149.9 to 235.9)
201.6
(129.4 to 314.2)
391.1
(303.1 to 504.6)
Opsono-14 Month 1 Number Analyzed 304 participants 82 participants 123 participants
2085.9
(1868 to 2329.1)
2134.2
(1689.1 to 2696.6)
977.8
(828.9 to 1153.5)
Opsono-18C PRE Number Analyzed 309 participants 82 participants 121 participants
8.7
(7.4 to 10.3)
10.4
(7.4 to 14.7)
8.5
(6.6 to 10.9)
Opsono-18C Month 1 Number Analyzed 299 participants 76 participants 121 participants
810.3
(712.4 to 921.7)
968.7
(724.1 to 1295.8)
610.7
(480.3 to 776.4)
Opsono-19F PRE Number Analyzed 317 participants 81 participants 123 participants
10.5
(8.9 to 12.3)
5.9
(4.5 to 7.8)
7.3
(5.5 to 9.6)
Opsono-19F Month 1 Number Analyzed 293 participants 80 participants 120 participants
624.3
(509.7 to 764.7)
287.8
(190.8 to 434.3)
530.1
(393 to 715.2)
Opsono-23F PRE Number Analyzed 305 participants 77 participants 120 participants
171.5
(126.3 to 232.8)
205.8
(110.1 to 384.6)
532.9
(344.4 to 824.7)
Opsono-23F Month 1 Number Analyzed 301 participants 80 participants 121 participants
2830.1
(2487.2 to 3220.3)
13900.7
(10177.4 to 18986.1)
2828.8
(2234.3 to 3581.6)
10.Secondary Outcome
Title Antibody Concentrations to Protein D (Anti-PD) - by Enzyme-Linked Immunosorbent Assay (ELISA)
Hide Description Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Time Frame Prior to (PRE) and one month (Month 1) post booster vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Arm/Group Title Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Hide Arm/Group Description:
This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
Overall Number of Participants Analyzed 340 86 134
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PD, PRE Number Analyzed 338 participants 73 participants 127 participants
556.4
(494.7 to 625.7)
72.3
(59.3 to 88)
78.1
(67.8 to 89.9)
Anti-PD, Month 1 Number Analyzed 340 participants 86 participants 134 participants
2887.6
(2573.7 to 3239.8)
75.3
(60 to 94.4)
125.5
(103.4 to 152.4)
11.Secondary Outcome
Title Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations
Hide Description Anti-PRP antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in microgram per milliliter (µg/mL), and tabulated. The seroprotection cut-off for the assay for the purpose of this endpoint was ≥ 0.15 µg/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Time Frame Prior to (PRE) and one month (Month 1) post booster vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Arm/Group Title Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Hide Arm/Group Description:
This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
Overall Number of Participants Analyzed 344 46 136
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Anti-PRP, PRE Number Analyzed 344 participants 39 participants 136 participants
0.308
(0.272 to 0.348)
0.231
(0.151 to 0.353)
0.246
(0.2 to 0.304)
Anti-PRP, Month 1 Number Analyzed 343 participants 46 participants 136 participants
36.634
(31.897 to 42.074)
25.731
(15.87 to 41.719)
29.851
(23.563 to 37.816)
12.Secondary Outcome
Title Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Hide Description Anti-PT, Anti-FHA and Anti-PRN concentrations measured by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 5 EL.U/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Time Frame Prior to (PRE) and one month (Month 1) post booster vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Arm/Group Title Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Hide Arm/Group Description:
This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
Overall Number of Participants Analyzed 344 46 136
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PT, PRE Number Analyzed 332 participants 34 participants 133 participants
5.5
(5.1 to 6.1)
7.3
(5.2 to 10.3)
7
(6.1 to 8.1)
Anti-PT, Month 1 Number Analyzed 338 participants 46 participants 135 participants
79.6
(73.8 to 85.9)
76
(60.4 to 95.7)
85.8
(76.9 to 95.7)
Anti-FHA, PRE Number Analyzed 343 participants 36 participants 135 participants
27.1
(24.4 to 30.1)
29
(20.5 to 40.8)
35.5
(29.7 to 42.3)
Anti-FHA, Month 1 Number Analyzed 343 participants 46 participants 136 participants
357.7
(332.6 to 384.7)
334.5
(278.1 to 402.2)
400.2
(356.4 to 449.5)
Anti-PRN, PRE Number Analyzed 344 participants 34 participants 136 participants
9.1
(8.2 to 10.1)
11.1
(7.6 to 16.2)
12.1
(10.1 to 14.6)
Anti-PRN, Month 1 Number Analyzed 342 participants 45 participants 135 participants
248.9
(226.5 to 273.4)
204.6
(155.8 to 268.7)
276.5
(239.1 to 319.7)
13.Secondary Outcome
Title Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Hide Description Anti-D and Anti-TT antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in International units per milliliter (IU/mL), and tabulated. The seropositivity cut-off for the assay was ≥ 0.1 IU/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Time Frame Prior to (PRE) and one month (Month 1) post booster vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Arm/Group Title Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Hide Arm/Group Description:
This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
Overall Number of Participants Analyzed 344 46 136
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-D, PRE Number Analyzed 344 participants 34 participants 136 participants
0.179
(0.161 to 0.199)
0.291
(0.2 to 0.424)
0.29
(0.25 to 0.336)
Anti-D, Month 1 Number Analyzed 343 participants 45 participants 136 participants
5.809
(5.352 to 6.305)
6.272
(4.883 to 8.055)
9.337
(8.419 to 10.356)
Anti-TT, PRE Number Analyzed 344 participants 35 participants 136 participants
0.417
(0.382 to 0.456)
0.261
(0.187 to 0.364)
0.265
(0.225 to 0.313)
Anti-TT, Month 1 Number Analyzed 343 participants 46 participants 136 participants
9.983
(9.293 to 10.724)
4.28
(3.294 to 5.562)
5.677
(5.038 to 6.397)
14.Secondary Outcome
Title Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
Hide Description Anti-HBs antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in milli-International unit per milliliter (IU/mL), and tabulated. The seropositivity cut-off for the assay was ≥ 10 mIU/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Time Frame Prior to (PRE) and one month (Month 1) post booster vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Arm/Group Title Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Hide Arm/Group Description:
This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
Overall Number of Participants Analyzed 329 48 134
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Anti-HBs, PRE Number Analyzed 329 participants 48 participants 134 participants
147.2
(124.7 to 173.7)
148.9
(100.4 to 220.8)
156.6
(125.5 to 195.5)
Anti-HBs, Month 1 Number Analyzed 325 participants 47 participants 132 participants
3869.1
(3218.1 to 4651.8)
3132.2
(1906.3 to 5146.5)
4358.6
(3495.5 to 5434.8)
15.Secondary Outcome
Title Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers
Hide Description Anti-Polio 1, 2 and 3 antibody titers were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seroprotection cut-off for the assay was ≥ 8. Antibody titers below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMT calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Time Frame Prior to (PRE) and one month (Month 1) post booster vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Arm/Group Title Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Hide Arm/Group Description:
This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
Overall Number of Participants Analyzed 318 48 131
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Polio 1, PRE Number Analyzed 318 participants 48 participants 131 participants
25.3
(21.9 to 29.3)
21.2
(15 to 30)
27.1
(20.7 to 35.4)
Anti-Polio 1, Month 1 Number Analyzed 279 participants 42 participants 121 participants
904.4
(779.7 to 1049.1)
819.3
(552.9 to 1214.2)
1003.7
(817.5 to 1232.3)
Anti-Polio 2, PRE Number Analyzed 317 participants 46 participants 130 participants
20.8
(18.1 to 24)
12.9
(8.8 to 18.9)
17.9
(14.1 to 22.8)
Anti-Polio 2 , Month 1 Number Analyzed 318 participants 48 participants 131 participants
793.5
(679.7 to 926.3)
495.7
(300.2 to 818.5)
661.2
(496.7 to 880.3)
Anti-Polio 3, PRE Number Analyzed 262 participants 39 participants 113 participants
33.7
(28.5 to 39.8)
25.8
(16.7 to 39.8)
28.2
(21.6 to 36.8)
Anti-Polio 3, Month 1 Number Analyzed 270 participants 41 participants 116 participants
1465
(1257.1 to 1707.3)
1191.7
(743.1 to 1911.3)
1646.5
(1294.4 to 2094.5)
16.Secondary Outcome
Title Number of Subjects Booster (BST) Responder to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin Antigens
Hide Description A BST responder to PT, FHA and PRN antigens was defined as a subject with the appearance of antibodies in subjects who were seronegative prior to the booster vaccination or at least 2-fold increase of pre-booster vaccination antibody concentrations in subjects who were seropositive prior to the booster vaccination. A seropositive/seronegative subject as regards Anti-PT/-FHA/ -PRN antibodies was defined as a subject with anti-PT/-FHA/ -PRN antibody concentrations ≥ 5 Enzyme-linked Immunosorbent assay (ELISA) unit per milli-liter (EL.U/mL)
Time Frame One month (Month 1) post booster vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Arm/Group Title Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Hide Arm/Group Description:
This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
Overall Number of Participants Analyzed 340 33 135
Measure Type: Count of Participants
Unit of Measure: Participants
BST responder to PT antigens Number Analyzed 324 participants 31 participants 132 participants
323
  99.7%
31
 100.0%
132
 100.0%
BST responder to FHA antigens Number Analyzed 340 participants 33 participants 135 participants
332
  97.6%
31
  93.9%
129
  95.6%
BST responder to PRN antigens Number Analyzed 340 participants 31 participants 135 participants
339
  99.7%
30
  96.8%
131
  97.0%
Time Frame From Month 1 (Active Phase) and up to Month 6 (Extended Safety Follow-Up)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Hide Arm/Group Description This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid. This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid. This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
All-Cause Mortality
Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/737 (0.00%)      0/92 (0.00%)      0/283 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/737 (4.48%)      6/92 (6.52%)      8/93 (8.60%)    
Blood and lymphatic system disorders       
Microcytic anaemia   1/737 (0.14%)  1 0/92 (0.00%)  0 0/93 (0.00%)  0
Gastrointestinal disorders       
Diarrhoea   1/737 (0.14%)  1 1/92 (1.09%)  1 0/93 (0.00%)  0
Gastritis   1/737 (0.14%)  1 0/92 (0.00%)  0 0/93 (0.00%)  0
Stomatitis   1/737 (0.14%)  1 0/92 (0.00%)  0 0/93 (0.00%)  0
General disorders       
Peripheral swelling   0/737 (0.00%)  0 0/92 (0.00%)  0 1/93 (1.08%)  1
Infections and infestations       
Adenovirus infection   1/737 (0.14%)  1 0/92 (0.00%)  0 0/93 (0.00%)  0
Bronchiolitis   0/737 (0.00%)  0 1/92 (1.09%)  1 0/93 (0.00%)  0
Bronchitis   2/737 (0.27%)  3 1/92 (1.09%)  1 4/93 (4.30%)  4
Ear infection   0/737 (0.00%)  0 1/92 (1.09%)  1 0/93 (0.00%)  0
Gastroenteritis   9/737 (1.22%)  9 0/92 (0.00%)  0 1/93 (1.08%)  1
Gastroenteritis rotavirus   1/737 (0.14%)  1 1/92 (1.09%)  1 1/93 (1.08%)  1
Laryngitis   1/737 (0.14%)  1 2/92 (2.17%)  2 0/93 (0.00%)  0
Nasopharyngitis   1/737 (0.14%)  1 0/92 (0.00%)  0 1/93 (1.08%)  1
Otitis media   0/737 (0.00%)  0 0/92 (0.00%)  0 1/93 (1.08%)  1
Pharyngitis   2/737 (0.27%)  2 0/92 (0.00%)  0 0/93 (0.00%)  0
Pneumonia   1/737 (0.14%)  1 0/92 (0.00%)  0 0/93 (0.00%)  0
Pyelonephritis   1/737 (0.14%)  1 0/92 (0.00%)  0 0/93 (0.00%)  0
Respiratory tract infection   1/737 (0.14%)  1 0/92 (0.00%)  0 0/93 (0.00%)  0
Upper respiratory tract infection   1/737 (0.14%)  1 0/92 (0.00%)  0 0/93 (0.00%)  0
Injury, poisoning and procedural complications       
Concussion   1/737 (0.14%)  1 0/92 (0.00%)  0 0/93 (0.00%)  0
Limb injury   1/737 (0.14%)  1 0/92 (0.00%)  0 0/93 (0.00%)  0
Thermal burn   0/737 (0.00%)  0 1/92 (1.09%)  1 0/93 (0.00%)  0
Toxicity to various agents   1/737 (0.14%)  1 0/92 (0.00%)  0 0/93 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration   1/737 (0.14%)  1 0/92 (0.00%)  0 0/93 (0.00%)  0
Weight gain poor   1/737 (0.14%)  1 0/92 (0.00%)  0 0/93 (0.00%)  0
Nervous system disorders       
Febrile convulsion   2/737 (0.27%)  2 0/92 (0.00%)  0 0/93 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma   1/737 (0.14%)  1 0/92 (0.00%)  0 0/93 (0.00%)  0
Bronchitis chronic   6/737 (0.81%)  6 0/92 (0.00%)  0 2/93 (2.15%)  2
Skin and subcutaneous tissue disorders       
Dermatitis atopic   1/737 (0.14%)  1 0/92 (0.00%)  0 0/93 (0.00%)  0
Purpura   1/737 (0.14%)  1 0/92 (0.00%)  0 0/93 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Synflorix-Synflorix Group Prevenar-Prevenar Group Prevenar-Synflorix Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   684/737 (92.81%)      85/92 (92.39%)      253/283 (89.40%)    
General disorders       
Injection site induration   1/737 (0.14%)  1 7/92 (7.61%)  7 7/283 (2.47%)  7
Pain   452/737 (61.33%)  452 48/92 (52.17%)  48 150/283 (53.00%)  150
Pyrexia   254/737 (34.46%)  254 35/92 (38.04%)  36 118/283 (41.70%)  124
Swelling   338/737 (45.86%)  339 42/92 (45.65%)  42 139/283 (49.12%)  139
Infections and infestations       
Otitis media   16/737 (2.17%)  17 4/92 (4.35%)  6 11/283 (3.89%)  12
Rhinitis   28/737 (3.80%)  28 4/92 (4.35%)  5 19/283 (6.71%)  20
Upper respiratory tract infection   24/737 (3.26%)  24 5/92 (5.43%)  6 13/283 (4.59%)  13
Metabolism and nutrition disorders       
Decreased appetite   230/737 (31.21%)  230 31/92 (33.70%)  31 92/283 (32.51%)  92
Nervous system disorders       
Somnolence   303/737 (41.11%)  303 48/92 (52.17%)  48 130/283 (45.94%)  130
Psychiatric disorders       
Irritability   438/737 (59.43%)  438 55/92 (59.78%)  56 176/283 (62.19%)  179
Respiratory, thoracic and mediastinal disorders       
Cough   7/737 (0.95%)  7 3/92 (3.26%)  3 14/283 (4.95%)  14
Skin and subcutaneous tissue disorders       
Erythema   454/737 (61.60%)  454 59/92 (64.13%)  59 153/283 (54.06%)  154
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00370396     History of Changes
Other Study ID Numbers: 107046
First Submitted: August 30, 2006
First Posted: August 31, 2006
Results First Submitted: August 31, 2017
Results First Posted: November 26, 2018
Last Update Posted: November 26, 2018