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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01262872
First received: December 2, 2010
Last updated: April 24, 2014
Last verified: March 2014
Results First Received: March 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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™

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Description of any significant events and approaches for the overall study following participant enrollment, but prior to group assignment.

Reporting Groups
  Description
10PP-HD 1d 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.
Prevnar13 1d 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 Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
10PP-LD 3+0d Group 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.
10PP-HD 3+0d Group 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.
Synflorix 3+0d Group 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.
Prevnar13 3+0d Group 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.
10PP-HD 2+1d Group 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.
Synflorix 2+1d Group 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.

Participant Flow for 2 periods

Period 1:   Step 1
    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  
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 2:   Step 2
    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  
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  
Other reason undisclosed                 0                 0                 9                 10                 5                 9                 9                 6  
[1] The 2 first groups included subjects for Step 1 alone. The 6 other groups were part of Step 2 alone.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
10PP-HD 1d 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.
Prevnar13 1d 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 Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
10PP-LD 3+0d Group 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.
10PP-HD 3+0d Group 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.
Synflorix 3+0d Group 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.
Prevnar13 3+0d Group 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.
10PP-HD 2+1d Group 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.
Synflorix 2+1d Group 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 Total of all reporting groups

Baseline Measures
    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  
Number of Participants  
[units: participants]
  60     60     200     200     200     200     200     200     1320  
Age  
[units: Years]
Mean ± Standard Deviation
  2.8  ± 0.40     2.9  ± 0.36     NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   2.9  ± 0.38  
Age  
[units: Weeks]
Mean ± Standard Deviation
  NA  ± NA [1]   NA  ± NA [1]   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  
Gender  
[units: Subjects]
                 
Female     41     26     NA [1]   NA [1]   NA [1]   NA [1]   NA [1]   NA [1]   NA [2]
Male     19     34     NA [1]   NA [1]   NA [1]   NA [1]   NA [1]   NA [1]   NA [2]
Gender  
[units: Subjects]
                 
Female     NA [1]   NA [1]   105     98     103     103     103     97     NA [2]
Male     NA [1]   NA [1]   95     102     97     97     97     103     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.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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   [ Time Frame: Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ]

2.  Primary:   Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination – For Step 1/Cohort 1 Subjects   [ Time Frame: Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ]

3.  Primary:   Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects   [ Time Frame: Within the 31-day (Days 0-30) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ]

4.  Primary:   Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects   [ Time Frame: From Day 0 to Month 1 ]

5.  Secondary:   Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges – For Cohort 1/Step 1 Subjects   [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ]

6.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs) – For Step 1/Cohort 1 Subjects   [ Time Frame: From Day 0 to Month 6 ]

7.  Secondary:   Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – For Cohort 1/Step 1 Subjects   [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ]

8.  Secondary:   Antibody Concentrations Against Protein D (PD) – For Cohort 1/Step 1 Subjects   [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ]

9.  Secondary:   Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 1/Step 1 Subjects   [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ]

10.  Secondary:   Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A – For Cohort 1/Step 1 Subjects   [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ]

11.  Secondary:   Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 1/Step 1 Subjects   [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ]

12.  Secondary:   Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A – For Cohort 1/Step 1 Subjects   [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ]

13.  Secondary:   Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-dPly Antibodies – For Cohort 1/Step 1 Subjects   [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ]

14.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms – For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule.   [ Time Frame: Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses ]

15.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms – For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.   [ Time Frame: Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses ]

16.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms – For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.   [ Time Frame: Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™) ]

17.  Secondary:   Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination – For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule   [ Time Frame: Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses ]

18.  Secondary:   Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses ]

19.  Secondary:   Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™) ]

20.  Secondary:   Number of Subjects With Any Unsolicited Adverse Events (AEs) – For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule   [ Time Frame: Within the 31-day (Days 0-30) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses ]

21.  Secondary:   Number of Subjects With Any Unsolicited Adverse Events (AEs) – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: Within the 31-day (Days 0-30) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses ]

22.  Primary:   Number of Subjects With Non-vaccine Types of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx – For Cohort 2/Step 2, Subjects 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™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

23.  Primary:   Number of Subjects With Non-vaccine Types of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx – For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule   [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

24.  Secondary:   Antibody Concentrations Against Vaccine Serotypes 6C – For Cohort 1/Step 1 Subjects   [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ]
Results not yet posted.   Anticipated Posting Date:   12/2050   Safety Issue:   No

25.  Secondary:   Titers for Opsonophagocytic Activity Against Vaccine Serotypes 6C – For Cohort 1/Step 1 Subjects   [ Time Frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™) ]
Results not yet posted.   Anticipated Posting Date:   12/2050   Safety Issue:   No

26.  Secondary:   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   [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

27.  Secondary:   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   [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

28.  Secondary:   Antibody Concentrations Against Protein D (PD) – For Cohort 2/Step 2 Subjects 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™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

29.  Secondary:   Antibody Concentrations Against Protein D (PD) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

30.  Secondary:   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   [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

31.  Secondary:   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   [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

32.  Secondary:   Antibody Concentrations Against Vaccine Serotypes 3, 6A, 6C and 19A – For Cohort 2/Step 2 Subjects Who Received 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™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

33.  Secondary:   Antibody Concentrations Against Vaccine Serotypes 3, 6A, 6C and 19A – For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule   [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

34.  Secondary:   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   [ Time Frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

35.  Secondary:   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   [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

36.  Secondary:   Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A, 6C and 19A – For Cohort 2/Step 2 Subjects 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™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

37.  Secondary:   Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A, 6C and 19A – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

38.  Secondary:   Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-dPly Antibodies – For Cohort 2/Step 2 Subjects 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™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

39.  Secondary:   Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-dPly Antibodies – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

40.  Secondary:   Concentrations of Antibodies Against Tetanus (Anti-T), Diphtheria (Anti-T), Bordetella Pertussis (Anti-BPT) and Polyribosyl Ribitol Phosphate (Anti-PRP) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule   [ Time Frame: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix or Prevnar 13™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

41.  Secondary:   Concentrations of Antibodies Against Tetanus (Anti-T), Diphtheria (Anti-T), Bordetella Pertussis (Anti-BPT) and Polyribosyl Ribitol Phosphate (Anti-PRP) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

42.  Secondary:   Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule   [ Time Frame: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix or Prevnar 13™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

43.  Secondary:   Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

44.  Secondary:   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   [ Time Frame: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix or Prevnar 13™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

45.  Secondary:   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 2+1 Schedule   [ Time Frame: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

46.  Secondary:   Titers of Antibodies Against Measles (Anti-Measles) and Against Yellow Fever (Anti-YF) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule   [ Time Frame: At 3 months post-vaccination with Stamaril™/M-Vac™ ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

47.  Secondary:   Titers of Antibodies Against Measles (Anti-Measles) and Against Yellow Fever (Anti-YF) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: At 3 months post-vaccination with Stamaril™/M-Vac™ ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

48.  Secondary:   Number of Subjects With Any Unsolicited Adverse Events (AEs) – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: Within the 31-day (Days 0-30) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   11/2014   Safety Issue:   No

49.  Secondary:   Number of Subjects With Any Serious Adverse Events (SAEs) – For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule   [ Time Frame: From Day 0 to Month 10 ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

50.  Secondary:   Number of Subjects With Any Serious Adverse Events (SAEs) – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: From Day 0 to Month 10 ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

51.  Secondary:   Number of Subjects With Vaccine Pneumoccocal Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx – For Cohort 2/Step 2 Subjects 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™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

52.  Secondary:   Number of Subjects With Vaccine Pneumoccocal Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

53.  Secondary:   Number of Subjects With Vaccine Cross-reactive Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx – For Cohort 2/Step 2 Subjects 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™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

54.  Secondary:   Number of Subjects With Vaccine Cross-reactive Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

55.  Secondary:   Number of Subjects With Acquisition of New Streptococcus Pneumoniae (S. pn.) Strains Identified in the Nasopharynx – For Cohort 2/Step 2 Subjects 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™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

56.  Secondary:   Number of Subjects With Acquisition of New Streptococcus Pneumoniae (S. pn.) Strains Identified in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

57.  Secondary:   Number of Subjects With Vaccine Haemophilus Influenzae (H. Influenzae) Strains Identified in the Nasopharynx – For Cohort 2/Step 2 Subjects 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™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

58.  Secondary:   Number of Subjects With Vaccine Haemophilus Influenzae (H. Influenzae) Strains Identified in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

59.  Secondary:   Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified in the Nasopharynx – For Cohort 2/Step 2 Subjects 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™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

60.  Secondary:   Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

61.  Secondary:   Number of Subjects With Vaccine Bacterial Pathogenic Strains Identified in the Nasopharynx Other Than Streptococcus Pneumoniae or Haemophilus Influenzae Strains – For Cohort 2/Step 2 Subjects 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™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

62.  Secondary:   Number of Subjects With Vaccine Bacterial Pathogenic Strains Identified in the Nasopharynx Other Than Streptococcus Pneumoniae or Haemophilus Influenzae Strains – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

63.  Secondary:   Number of Subjects With Non-vaccine Streptococcus Pneumoniae (S. pn.) Strains Identified in the Nasopharynx – For Cohort 2/Step 2 Subjects 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™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

64.  Secondary:   Number of Subjects With Non-vaccine Streptococcus Pneumoniae (S. pn.) Strains Identified in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

65.  Secondary:   Number of Subjects With Non-vaccine Haemophilus Influenzae Strains Identified in the Nasopharynx – For Cohort 2/Step 2 Subjects 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™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

66.  Secondary:   Number of Subjects With Non-vaccine Haemophilus Influenzae Strains Identified in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

67.  Secondary:   Number of Subjects With Non-vaccine Bacterial Pathogenic Strains Identified in the Nasopharynx – For Cohort 2/Step 2 Subjects 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™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No

68.  Secondary:   Number of Subjects With Non-vaccine Bacterial Pathogenic Strains Identified in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule   [ Time Frame: At 1 and 5 months post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™) ]
Results not yet posted.   Anticipated Posting Date:   09/2014   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01262872     History of Changes
Other Study ID Numbers: 114174
Study First Received: December 2, 2010
Results First Received: March 13, 2014
Last Updated: April 24, 2014
Health Authority: Gambia: Ministry of Health