Trial Outcomes & Findings for Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety & Immunogenicity in Children & Infants (NCT NCT01262872)
NCT ID: NCT01262872
Last Updated: 2019-06-19
Results Overview
Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). All solicited local symptoms were systematically considered by the investigators as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 symptoms. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1320 participants
Primary outcome timeframe
Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Results posted on
2019-06-19
Participant Flow
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.
Description of any significant events and approaches for the overall study following participant enrollment, but prior to group assignment.
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|---|---|---|---|
|
Step 1
STARTED
|
60
|
60
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 1
COMPLETED
|
60
|
60
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 2
STARTED
|
0
|
0
|
200
|
200
|
200
|
200
|
200
|
200
|
|
Step 2
COMPLETED
|
0
|
0
|
191
|
190
|
195
|
191
|
191
|
194
|
|
Step 2
NOT COMPLETED
|
0
|
0
|
9
|
10
|
5
|
9
|
9
|
6
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|---|---|---|---|---|
|
Step 2
Death
|
0
|
0
|
0
|
1
|
0
|
2
|
2
|
1
|
|
Step 2
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
0
|
3
|
1
|
|
Step 2
Withdrawal by Subject
|
0
|
0
|
4
|
6
|
3
|
1
|
2
|
1
|
|
Step 2
Migrated/moved from study area
|
0
|
0
|
4
|
3
|
2
|
6
|
2
|
3
|
Baseline Characteristics
Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety & Immunogenicity in Children & Infants
Baseline characteristics by cohort
| Measure |
10PP-HD 1d Group
n=60 Participants
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
n=60 Participants
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
n=200 Participants
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
n=200 Participants
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
n=200 Participants
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
n=200 Participants
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
n=200 Participants
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
n=200 Participants
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
n=1320 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
NA Weeks
STANDARD_DEVIATION NA • n=5 Participants
|
NA Weeks
STANDARD_DEVIATION NA • n=7 Participants
|
8.5 Weeks
STANDARD_DEVIATION 0.64 • n=5 Participants
|
8.4 Weeks
STANDARD_DEVIATION 0.61 • n=4 Participants
|
8.4 Weeks
STANDARD_DEVIATION 0.63 • n=21 Participants
|
8.5 Weeks
STANDARD_DEVIATION 0.69 • n=10 Participants
|
8.5 Weeks
STANDARD_DEVIATION 0.70 • n=115 Participants
|
8.5 Weeks
STANDARD_DEVIATION 0.70 • n=24 Participants
|
8.5 Weeks
STANDARD_DEVIATION 0.66 • n=42 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
103 Participants
n=10 Participants
|
103 Participants
n=115 Participants
|
97 Participants
n=24 Participants
|
NA Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
97 Participants
n=10 Participants
|
97 Participants
n=115 Participants
|
103 Participants
n=24 Participants
|
NA Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
African heritage
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
200 Participants
n=21 Participants
|
200 Participants
n=10 Participants
|
200 Participants
n=115 Participants
|
200 Participants
n=24 Participants
|
NA Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). All solicited local symptoms were systematically considered by the investigators as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 symptoms. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Outcome measures
| Measure |
10PP-HD 1d Group
n=60 Participants
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
n=60 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
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
Any Redness
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
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
Any Pain
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
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
Grade 3 Pain
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
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
Grade 3 Redness
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
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
Any Swelling
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
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
Grade 3 Swelling
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than \[≥\] 37.5 degrees Celsius \[°C\]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (\>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Primary results correspond to results for occurrences of Grade 3 symptoms assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Outcome measures
| Measure |
10PP-HD 1d Group
n=60 Participants
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
n=60 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects
Grade 3 Loss of appetite
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects
Any Drowsiness
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects
Grade 3 Drowsiness
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects
Related Drowsiness
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects
Grade 3 & Related Drowsiness
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects
Any Fever
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects
Grade 3 Fever
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects
Related Fever
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects
Grade 3 & Related Fever
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects
Any Irritability/Fussiness
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects
Grade 3 Irritability/Fussiness
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects
Related Irritability/Fussiness
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects
Grade 3 & Related Irritability/Fussiness
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects
Any Loss of appetite
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects
Related Loss of appetite
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects
Grade 3 & Related Loss of appetite
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within the 31-day (Days 0-30) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of AE, regardless of intensity or relationship to vaccination. Grade 3 = Occurrence of AE which prevented normal activities. Related = Occurrence of AE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 unsolicited AE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Outcome measures
| Measure |
10PP-HD 1d Group
n=60 Participants
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
n=60 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects
Any unsolicited AE(s)
|
13 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects
Grade 3 unsolicited AE(s)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects
Related unsolicited AE(s)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects
Grade 3 and related unsolicited AE(s)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 0 to Month 1Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. Related = Occurrence of an SAE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of SAE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Outcome measures
| Measure |
10PP-HD 1d Group
n=60 Participants
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
n=60 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects
Any SAE(s)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects
SAE(s) related to vaccination
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of the isolates.
Outcome measures
| Measure |
10PP-HD 1d Group
n=193 Participants
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
n=194 Participants
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.
|
Synflorix 3+0d Group
n=196 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule
1 Mth post dose 3
|
154 Participants
|
137 Participants
|
145 Participants
|
—
|
—
|
|
Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule
5 Mth post dose 3
|
148 Participants
|
149 Participants
|
159 Participants
|
—
|
—
|
|
Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule
8 Mth post dose 3
|
151 Participants
|
154 Participants
|
159 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of isolates.
Outcome measures
| Measure |
10PP-HD 1d Group
n=197 Participants
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
n=197 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule
5 Mth post dose 2
|
146 Participants
|
160 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule
3 Mth post dose 3
|
165 Participants
|
162 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule
1 Mth post dose 2
|
142 Participants
|
152 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Assessed biochemical and haematological parameters were: Haemoglobin (Hgb), White cell count (WBC), Platelet counts, Alanine aminotransferase (ALT) and Creatinine (CREA). Per parameter, it was assessed whether subjects had laboratory values below normal, normal, or above normal range. Below = value below the laboratory reference range defined for the specified time point and laboratory parameter. Within = value within the laboratory reference range defined for the specified time point and laboratory parameter. Above = value above the laboratory reference range defined for the specified time point and laboratory parameter. Unknown = value unknown for the specified time point and laboratory parameter. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Outcome measures
| Measure |
10PP-HD 1d Group
n=60 Participants
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
n=60 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
ALT - Status: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
ALT - Status: Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
ALT - Status: Within
|
60 Participants
|
57 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
ALT - Status: Above
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
CREA - Status: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
CREA - Status: Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
CREA - Status: Within
|
60 Participants
|
60 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
CREA - Status: Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
Hgb - Status: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
Hgb - Status: Below
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
Hgb - Status: Within
|
57 Participants
|
56 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
Hgb - Status: Above
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
Platelets - Status: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
Platelets - Status: Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
Platelets - Status: Within
|
59 Participants
|
60 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
Platelets - Status: Above
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
WBC - Status: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
WBC - Status: Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
WBC - Status: Within
|
60 Participants
|
60 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
WBC - Status: Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Month 6Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Outcome measures
| Measure |
10PP-HD 1d Group
n=60 Participants
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
n=60 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) - For Step 1/Cohort 1 Subjects
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Anti-Ply and anti-PhtD antibody concentrations were measured by Multiplex immunoassay and expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 599 LU/mL for anti-Ply antibodies and ≥ 391 LU/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Outcome measures
| Measure |
10PP-HD 1d Group
n=52 Participants
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
n=51 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 1/Step 1 Subjects
Anti-Ply
|
22794.9 LU/mL
Interval 17570.1 to 29573.3
|
8510.3 LU/mL
Interval 6668.5 to 10860.8
|
—
|
—
|
—
|
|
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 1/Step 1 Subjects
Anti-PhtD
|
31326.3 LU/mL
Interval 26293.9 to 37321.8
|
16810.0 LU/mL
Interval 13516.3 to 20906.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Anti-PD antibody concentrations were measured by Multiplex immunoassay, expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 112 LU/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Outcome measures
| Measure |
10PP-HD 1d Group
n=52 Participants
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
n=51 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Antibody Concentrations Against Protein D (PD) - For Cohort 1/Step 1 Subjects
|
137.5 LU/mL
Interval 108.4 to 174.4
|
65.1 LU/mL
Interval 58.2 to 72.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Outcome measures
| Measure |
10PP-HD 1d Group
n=52 Participants
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
n=51 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
Anti-1 antibodies
|
1.71 µg/mL
Interval 1.33 to 2.22
|
3.12 µg/mL
Interval 2.44 to 4.01
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
Anti-4 antibodies
|
4.80 µg/mL
Interval 3.75 to 6.14
|
4.17 µg/mL
Interval 3.33 to 5.21
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
Anti-5 antibodies
|
1.17 µg/mL
Interval 0.88 to 1.55
|
1.47 µg/mL
Interval 1.08 to 1.99
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
Anti-6B antibodies
|
0.50 µg/mL
Interval 0.34 to 0.73
|
1.57 µg/mL
Interval 0.98 to 2.51
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
Anti-7F antibodies
|
2.44 µg/mL
Interval 1.99 to 2.98
|
6.11 µg/mL
Interval 4.44 to 8.41
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
Anti-9V antibodies
|
0.89 µg/mL
Interval 0.71 to 1.12
|
2.41 µg/mL
Interval 1.87 to 3.26
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
Anti-14 antibodies
|
1.88 µg/mL
Interval 1.39 to 2.53
|
3.77 µg/mL
Interval 2.61 to 5.43
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
Anti-18C antibodies
|
7.58 µg/mL
Interval 5.43 to 10.57
|
4.82 µg/mL
Interval 3.46 to 6.71
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
Anti-19F antibodies
|
7.82 µg/mL
Interval 5.84 to 10.46
|
5.95 µg/mL
Interval 4.48 to 7.9
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
Anti-23F antibodies
|
0.31 µg/mL
Interval 0.21 to 0.46
|
1.11 µg/mL
Interval 0.74 to 1.67
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Outcome measures
| Measure |
10PP-HD 1d Group
n=52 Participants
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
n=51 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects
Anti-3 antibodies
|
0.25 µg/mL
Interval 0.14 to 0.46
|
2.35 µg/mL
Interval 1.77 to 3.12
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects
Anti-6A antibodies
|
0.18 µg/mL
Interval 0.12 to 0.27
|
1.36 µg/mL
Interval 0.96 to 1.93
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects
Anti-19A antibodies
|
1.38 µg/mL
Interval 0.91 to 2.1
|
5.51 µg/mL
Interval 4.02 to 7.55
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Outcome measures
| Measure |
10PP-HD 1d Group
n=52 Participants
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
n=51 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
OPSONO-23F
|
2756.7 Titers
Interval 1638.0 to 4639.5
|
12652.4 Titers
Interval 8076.0 to 19822.2
|
—
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
OPSONO-1
|
17.2 Titers
Interval 11.2 to 26.4
|
112.8 Titers
Interval 71.9 to 177.0
|
—
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
OPSONO-4
|
2818.9 Titers
Interval 2009.7 to 3953.8
|
4162.3 Titers
Interval 3123.9 to 5545.9
|
—
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
OPSONO-5
|
9.0 Titers
Interval 6.4 to 12.7
|
89.8 Titers
Interval 55.8 to 144.5
|
—
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
OPSONO-6B
|
345.3 Titers
Interval 171.4 to 695.5
|
5082.5 Titers
Interval 3700.2 to 6981.2
|
—
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
OPSONO-7F
|
6214.0 Titers
Interval 5217.1 to 7401.4
|
17781.0 Titers
Interval 14034.2 to 22528.0
|
—
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
OPSONO-9V
|
2880.8 Titers
Interval 2264.8 to 3664.5
|
12687.8 Titers
Interval 9188.2 to 17520.2
|
—
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
OPSONO-14
|
1116.1 Titers
Interval 715.5 to 1741.0
|
5985.9 Titers
Interval 4313.1 to 8307.4
|
—
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
OPSONO-18C
|
3955.4 Titers
Interval 3027.7 to 5167.2
|
2799.8 Titers
Interval 1931.1 to 4059.2
|
—
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
OPSONO-19F
|
862.9 Titers
Interval 529.2 to 1407.0
|
452.8 Titers
Interval 276.2 to 742.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Outcome measures
| Measure |
10PP-HD 1d Group
n=51 Participants
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
n=51 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects
OPSONO-3
|
10.1 Titers
Interval 6.5 to 15.8
|
152.5 Titers
Interval 120.4 to 193.2
|
—
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects
OPSONO-6A
|
212.7 Titers
Interval 110.4 to 410.0
|
8488.8 Titers
Interval 5984.2 to 12041.8
|
—
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects
OPSONO-19A
|
461.7 Titers
Interval 277.2 to 769.0
|
970.3 Titers
Interval 701.0 to 1342.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Concentrations of Hem-Ply antibodies were expressed as geometric mean titers . The cut-off of the assay was an Hem-Ply antibody titer ≥ 140. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Outcome measures
| Measure |
10PP-HD 1d Group
n=52 Participants
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
n=51 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 1/Step 1 Subjects
|
682.3 Titers
Interval 562.8 to 827.3
|
534.0 Titers
Interval 439.4 to 648.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=192 Participants
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
n=195 Participants
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.
|
Synflorix 3+0d Group
n=196 Participants
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
n=195 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
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
Anti-Ply 1 Mth post dose 3
|
13968.86 EL.U/mL
Interval 12612.27 to 15471.36
|
16771.16 EL.U/mL
Interval 15267.84 to 18422.51
|
451.32 EL.U/mL
Interval 398.68 to 510.91
|
419.47 EL.U/mL
Interval 377.26 to 466.4
|
—
|
|
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
Anti-Ply 5 Mth post dose 3
|
11268.35 EL.U/mL
Interval 9870.36 to 12864.36
|
10817.78 EL.U/mL
Interval 9528.87 to 12281.04
|
744.86 EL.U/mL
Interval 631.27 to 878.89
|
637.49 EL.U/mL
Interval 539.55 to 753.22
|
—
|
|
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
Anti-Ply 8 Mth post dose 3
|
10512.39 EL.U/mL
Interval 9249.03 to 11948.33
|
10299.57 EL.U/mL
Interval 9137.48 to 11609.44
|
999.39 EL.U/mL
Interval 861.41 to 1159.49
|
884.83 EL.U/mL
Interval 748.83 to 1045.54
|
—
|
|
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
Anti-PhtD 1 Mth post dose 3
|
2584.28 EL.U/mL
Interval 2292.67 to 2912.98
|
2188.28 EL.U/mL
Interval 1934.94 to 2474.8
|
334.18 EL.U/mL
Interval 292.9 to 381.28
|
486.01 EL.U/mL
Interval 419.64 to 562.87
|
—
|
|
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
Anti-PhtD 5 Mth post dose 3
|
2242.06 EL.U/mL
Interval 1971.08 to 2550.29
|
1498.86 EL.U/mL
Interval 1311.05 to 1713.57
|
936.83 EL.U/mL
Interval 780.23 to 1124.86
|
1419.77 EL.U/mL
Interval 1196.01 to 1685.4
|
—
|
|
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
Anti-PhtD 8 Mth post dose 3
|
2608.78 EL.U/mL
Interval 2318.09 to 2935.92
|
2078.35 EL.U/mL
Interval 1861.91 to 2319.95
|
1667.91 EL.U/mL
Interval 1432.09 to 1942.55
|
2380.09 EL.U/mL
Interval 2118.18 to 2674.39
|
—
|
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=193 Participants
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
n=193 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
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
Anti-Ply 1 Mth post dose 2
|
11491.54 EL.U/mL
Interval 10168.1 to 12987.23
|
488.79 EL.U/mL
Interval 427.38 to 559.01
|
—
|
—
|
—
|
|
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
Anti-Ply 5 Mth post dose 2
|
7453.65 EL.U/mL
Interval 6460.7 to 8599.21
|
807.67 EL.U/mL
Interval 676.2 to 964.7
|
—
|
—
|
—
|
|
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
Anti-Ply 3 Mth post dose 3
|
17933.07 EL.U/mL
Interval 15867.0 to 20268.17
|
1114.25 EL.U/mL
Interval 945.08 to 1313.71
|
—
|
—
|
—
|
|
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
Anti-PhtD 1 Mth post dose 2
|
1264.57 EL.U/mL
Interval 1103.87 to 1448.66
|
368.62 EL.U/mL
Interval 319.88 to 424.79
|
—
|
—
|
—
|
|
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
Anti-PhtD 5 Mth post dose 2
|
1448.08 EL.U/mL
Interval 1253.08 to 1673.41
|
1036.53 EL.U/mL
Interval 853.8 to 1258.36
|
—
|
—
|
—
|
|
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
Anti-PhtD 3 Mth post dose 3
|
3250.91 EL.U/mL
Interval 2956.18 to 3575.02
|
1654.79 EL.U/mL
Interval 1415.54 to 1934.47
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=191 Participants
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
n=193 Participants
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.
|
Synflorix 3+0d Group
n=194 Participants
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
n=189 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Anti-PD 8 Mth post dose 3
|
324.3 EL.U/mL
Interval 282.2 to 372.7
|
288.2 EL.U/mL
Interval 248.5 to 334.2
|
344.2 EL.U/mL
Interval 300.6 to 394.2
|
69.2 EL.U/mL
Interval 63.6 to 75.3
|
—
|
|
Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Anti-PD 1 Mth post dose 3
|
1922.8 EL.U/mL
Interval 1739.3 to 2125.6
|
1833.8 EL.U/mL
Interval 1628.5 to 2065.0
|
1990.2 EL.U/mL
Interval 1765.7 to 2243.3
|
84.8 EL.U/mL
Interval 76.4 to 94.1
|
—
|
|
Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Anti-PD 5 Mth post dose 3
|
559.2 EL.U/mL
Interval 496.8 to 629.6
|
499.2 EL.U/mL
Interval 439.9 to 566.5
|
609.9 EL.U/mL
Interval 537.0 to 692.8
|
83.1 EL.U/mL
Interval 74.9 to 92.2
|
—
|
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=190 Participants
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
n=190 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Anti-PD 1 Mth post dose 2
|
990.9 EL.U/mL
Interval 869.3 to 1129.5
|
1126.7 EL.U/mL
Interval 999.4 to 1270.2
|
—
|
—
|
—
|
|
Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Anti-PD 5 Mth post dose 2
|
281.3 EL.U/mL
Interval 247.5 to 319.7
|
313.0 EL.U/mL
Interval 276.2 to 354.7
|
—
|
—
|
—
|
|
Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Anti-PD 3 Mth post dose 3
|
534.8 EL.U/mL
Interval 468.9 to 610.0
|
664.9 EL.U/mL
Interval 580.1 to 762.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=191 Participants
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
n=195 Participants
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.
|
Synflorix 3+0d Group
n=196 Participants
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
n=195 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
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
Anti-1 1 Mth post dose 3
|
3.58 µg/mL
Interval 3.17 to 4.03
|
3.20 µg/mL
Interval 2.82 to 3.63
|
3.38 µg/mL
Interval 2.98 to 3.83
|
5.51 µg/mL
Interval 4.92 to 6.17
|
—
|
|
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
Anti-1 5 Mth post dose 3
|
0.67 µg/mL
Interval 0.59 to 0.76
|
0.55 µg/mL
Interval 0.49 to 0.63
|
0.62 µg/mL
Interval 0.55 to 0.71
|
1.16 µg/mL
Interval 1.05 to 1.29
|
—
|
|
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
Anti-1 8 Mth post dose 3
|
0.40 µg/mL
Interval 0.35 to 0.45
|
0.35 µg/mL
Interval 0.31 to 0.4
|
0.40 µg/mL
Interval 0.35 to 0.46
|
0.83 µg/mL
Interval 0.73 to 0.93
|
—
|
|
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
Anti-4 1 Mth post dose 3
|
3.89 µg/mL
Interval 3.43 to 4.41
|
3.15 µg/mL
Interval 2.75 to 3.6
|
3.75 µg/mL
Interval 3.29 to 4.28
|
6.25 µg/mL
Interval 5.63 to 6.93
|
—
|
|
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
Anti-4 5 Mth post dose 3
|
1.19 µg/mL
Interval 1.06 to 1.34
|
1.04 µg/mL
Interval 0.93 to 1.16
|
1.14 µg/mL
Interval 1.0 to 1.29
|
1.06 µg/mL
Interval 0.94 to 1.19
|
—
|
|
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
Anti-4 8 Mth post dose 3
|
0.70 µg/mL
Interval 0.62 to 0.79
|
0.59 µg/mL
Interval 0.52 to 0.68
|
0.66 µg/mL
Interval 0.58 to 0.76
|
0.54 µg/mL
Interval 0.48 to 0.61
|
—
|
|
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
Anti-5 1 Mth post dose 3
|
5.17 µg/mL
Interval 4.54 to 5.88
|
4.83 µg/mL
Interval 4.21 to 5.54
|
5.30 µg/mL
Interval 4.66 to 6.02
|
7.02 µg/mL
Interval 6.14 to 8.02
|
—
|
|
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
Anti-5 5 Mth post dose 3
|
1.37 µg/mL
Interval 1.21 to 1.55
|
1.25 µg/mL
Interval 1.1 to 1.43
|
1.33 µg/mL
Interval 1.17 to 1.51
|
1.79 µg/mL
Interval 1.59 to 2.02
|
—
|
|
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
Anti-5 8 Mth post dose 3
|
0.73 µg/mL
Interval 0.65 to 0.83
|
0.68 µg/mL
Interval 0.59 to 0.79
|
0.69 µg/mL
Interval 0.6 to 0.79
|
1.12 µg/mL
Interval 0.99 to 1.27
|
—
|
|
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
Anti-6B 1 Mth post dose 3
|
0.91 µg/mL
Interval 0.74 to 1.12
|
0.69 µg/mL
Interval 0.56 to 0.86
|
1.00 µg/mL
Interval 0.8 to 1.25
|
1.35 µg/mL
Interval 1.11 to 1.65
|
—
|
|
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
Anti-6B 5 Mth post dose 3
|
1.10 µg/mL
Interval 0.94 to 1.29
|
0.86 µg/mL
Interval 0.73 to 1.01
|
1.24 µg/mL
Interval 1.06 to 1.44
|
0.38 µg/mL
Interval 0.33 to 0.44
|
—
|
|
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
Anti-6B 8 Mth post dose 3
|
0.87 µg/mL
Interval 0.75 to 1.0
|
0.73 µg/mL
Interval 0.62 to 0.86
|
0.96 µg/mL
Interval 0.83 to 1.11
|
0.29 µg/mL
Interval 0.26 to 0.34
|
—
|
|
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
Anti-7F 1 Mth post dose 3
|
4.63 µg/mL
Interval 4.1 to 5.22
|
4.10 µg/mL
Interval 3.62 to 4.63
|
4.29 µg/mL
Interval 3.77 to 4.88
|
5.53 µg/mL
Interval 4.96 to 6.17
|
—
|
|
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
Anti-7F 5 Mth post dose 3
|
2.24 µg/mL
Interval 2.01 to 2.5
|
1.84 µg/mL
Interval 1.63 to 2.08
|
2.19 µg/mL
Interval 1.95 to 2.47
|
2.21 µg/mL
Interval 1.99 to 2.45
|
—
|
|
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
Anti-7F 8 Mth post dose 3
|
1.54 µg/mL
Interval 1.38 to 1.72
|
1.31 µg/mL
Interval 1.15 to 1.5
|
1.57 µg/mL
Interval 1.39 to 1.78
|
1.65 µg/mL
Interval 1.49 to 1.82
|
—
|
|
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
Anti-9V 1 Mth post dose 3
|
3.23 µg/mL
Interval 2.83 to 3.68
|
3.25 µg/mL
Interval 2.83 to 3.72
|
3.26 µg/mL
Interval 2.82 to 3.78
|
4.02 µg/mL
Interval 3.45 to 4.69
|
—
|
|
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
Anti-9V 5 Mth post dose 3
|
1.35 µg/mL
Interval 1.2 to 1.53
|
1.15 µg/mL
Interval 1.02 to 1.3
|
1.33 µg/mL
Interval 1.17 to 1.52
|
0.83 µg/mL
Interval 0.72 to 0.95
|
—
|
|
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
Anti-9V 8 Mth post dose 3
|
1.09 µg/mL
Interval 0.95 to 1.25
|
0.87 µg/mL
Interval 0.77 to 1.0
|
1.08 µg/mL
Interval 0.95 to 1.23
|
0.63 µg/mL
Interval 0.55 to 0.73
|
—
|
|
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
Anti-14 1 Mth post dose 3
|
4.36 µg/mL
Interval 3.7 to 5.13
|
4.11 µg/mL
Interval 3.49 to 4.85
|
4.15 µg/mL
Interval 3.52 to 4.89
|
4.66 µg/mL
Interval 3.93 to 5.52
|
—
|
|
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
Anti-14 5 Mth post dose 3
|
2.15 µg/mL
Interval 1.84 to 2.5
|
1.86 µg/mL
Interval 1.56 to 2.22
|
2.13 µg/mL
Interval 1.77 to 2.56
|
3.43 µg/mL
Interval 2.89 to 4.06
|
—
|
|
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
Anti-14 8 Mth post dose 3
|
1.38 µg/mL
Interval 1.18 to 1.61
|
1.37 µg/mL
Interval 1.15 to 1.63
|
1.42 µg/mL
Interval 1.18 to 1.71
|
2.47 µg/mL
Interval 2.1 to 2.92
|
—
|
|
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
Anti-18C 1 Mth post dose 3
|
15.88 µg/mL
Interval 13.8 to 18.26
|
14.84 µg/mL
Interval 12.88 to 17.09
|
15.66 µg/mL
Interval 13.52 to 18.14
|
5.78 µg/mL
Interval 5.03 to 6.64
|
—
|
|
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
Anti-18C 5 Mth post dose 3
|
4.09 µg/mL
Interval 3.54 to 4.71
|
3.52 µg/mL
Interval 3.06 to 4.05
|
4.17 µg/mL
Interval 3.6 to 4.83
|
0.95 µg/mL
Interval 0.84 to 1.06
|
—
|
|
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
Anti-18C 8 Mth post dose 3
|
2.18 µg/mL
Interval 1.9 to 2.51
|
1.82 µg/mL
Interval 1.58 to 2.1
|
2.24 µg/mL
Interval 1.95 to 2.58
|
0.66 µg/mL
Interval 0.58 to 0.75
|
—
|
|
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
Anti-19F 1 Mth post dose 3
|
9.47 µg/mL
Interval 8.08 to 11.09
|
9.36 µg/mL
Interval 8.04 to 10.91
|
10.04 µg/mL
Interval 8.54 to 11.8
|
5.99 µg/mL
Interval 5.4 to 6.64
|
—
|
|
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
Anti-19F 5 Mth post dose 3
|
2.65 µg/mL
Interval 2.29 to 3.07
|
2.34 µg/mL
Interval 2.03 to 2.71
|
3.11 µg/mL
Interval 2.67 to 3.62
|
0.96 µg/mL
Interval 0.83 to 1.11
|
—
|
|
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
Anti-19F 8 Mth post dose 3
|
1.65 µg/mL
Interval 1.4 to 1.93
|
1.45 µg/mL
Interval 1.22 to 1.72
|
1.99 µg/mL
Interval 1.68 to 2.35
|
0.55 µg/mL
Interval 0.46 to 0.66
|
—
|
|
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
Anti-23F 1 Mth post dose 3
|
1.18 µg/mL
Interval 0.98 to 1.42
|
1.14 µg/mL
Interval 0.95 to 1.38
|
1.22 µg/mL
Interval 0.99 to 1.51
|
2.92 µg/mL
Interval 2.47 to 3.44
|
—
|
|
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
Anti-23F 5 Mth post dose 3
|
0.78 µg/mL
Interval 0.66 to 0.93
|
0.77 µg/mL
Interval 0.66 to 0.89
|
0.90 µg/mL
Interval 0.77 to 1.06
|
0.47 µg/mL
Interval 0.4 to 0.57
|
—
|
|
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
Anti-23F 8 Mth post dose 3
|
0.62 µg/mL
Interval 0.53 to 0.73
|
0.59 µg/mL
Interval 0.49 to 0.7
|
0.68 µg/mL
Interval 0.58 to 0.79
|
0.39 µg/mL
Interval 0.31 to 0.48
|
—
|
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=193 Participants
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
n=193 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
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
Anti-1 1 Mth post dose 2
|
2.52 µg/mL
Interval 2.22 to 2.86
|
2.41 µg/mL
Interval 2.13 to 2.72
|
—
|
—
|
—
|
|
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
Anti-1 5 Mth post dose 2
|
0.44 µg/mL
Interval 0.39 to 0.49
|
0.42 µg/mL
Interval 0.37 to 0.48
|
—
|
—
|
—
|
|
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
Anti-1 3 Mth post dose 3
|
1.65 µg/mL
Interval 1.43 to 1.9
|
1.61 µg/mL
Interval 1.41 to 1.83
|
—
|
—
|
—
|
|
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
Anti-4 1 Mth post dose 2
|
2.79 µg/mL
Interval 2.42 to 3.22
|
2.67 µg/mL
Interval 2.3 to 3.09
|
—
|
—
|
—
|
|
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
Anti-4 5 Mth post dose 2
|
0.79 µg/mL
Interval 0.7 to 0.89
|
0.76 µg/mL
Interval 0.67 to 0.86
|
—
|
—
|
—
|
|
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
Anti-4 3 Mth post dose 3
|
2.15 µg/mL
Interval 1.91 to 2.42
|
1.92 µg/mL
Interval 1.71 to 2.16
|
—
|
—
|
—
|
|
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
Anti-5 1 Mth post dose 2
|
3.74 µg/mL
Interval 3.29 to 4.26
|
3.40 µg/mL
Interval 2.96 to 3.91
|
—
|
—
|
—
|
|
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
Anti-5 5 Mth post dose 2
|
1.07 µg/mL
Interval 0.95 to 1.21
|
0.92 µg/mL
Interval 0.81 to 1.04
|
—
|
—
|
—
|
|
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
Anti-5 3 Mth post dose 3
|
2.86 µg/mL
Interval 2.53 to 3.23
|
2.34 µg/mL
Interval 2.04 to 2.69
|
—
|
—
|
—
|
|
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
Anti-6B 1 Mth post dose 2
|
0.51 µg/mL
Interval 0.4 to 0.64
|
0.51 µg/mL
Interval 0.41 to 0.64
|
—
|
—
|
—
|
|
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
Anti-6B 5 Mth post dose 2
|
0.63 µg/mL
Interval 0.53 to 0.75
|
0.67 µg/mL
Interval 0.58 to 0.79
|
—
|
—
|
—
|
|
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
Anti-6B 3 Mth post dose 3
|
1.35 µg/mL
Interval 1.17 to 1.56
|
1.39 µg/mL
Interval 1.21 to 1.61
|
—
|
—
|
—
|
|
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
Anti-7F 1 Mth post dose 2
|
3.29 µg/mL
Interval 2.95 to 3.67
|
3.06 µg/mL
Interval 2.68 to 3.49
|
—
|
—
|
—
|
|
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
Anti-7F 5 Mth post dose 2
|
1.47 µg/mL
Interval 1.3 to 1.66
|
1.48 µg/mL
Interval 1.3 to 1.68
|
—
|
—
|
—
|
|
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
Anti-7F 3 Mth post dose 3
|
3.36 µg/mL
Interval 3.0 to 3.77
|
3.40 µg/mL
Interval 3.04 to 3.81
|
—
|
—
|
—
|
|
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
Anti-9V 1 Mth post dose 2
|
1.85 µg/mL
Interval 1.6 to 2.14
|
1.97 µg/mL
Interval 1.72 to 2.26
|
—
|
—
|
—
|
|
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
Anti-9V 5 Mth post dose 2
|
0.85 µg/mL
Interval 0.75 to 0.95
|
0.81 µg/mL
Interval 0.72 to 0.91
|
—
|
—
|
—
|
|
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
Anti-9V 3 Mth post dose 3
|
2.86 µg/mL
Interval 2.54 to 3.23
|
2.67 µg/mL
Interval 2.32 to 3.06
|
—
|
—
|
—
|
|
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
Anti-14 1 Mth post dose 2
|
2.39 µg/mL
Interval 2.01 to 2.85
|
2.29 µg/mL
Interval 1.92 to 2.72
|
—
|
—
|
—
|
|
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
Anti-14 5 Mth post dose 2
|
0.85 µg/mL
Interval 0.7 to 1.03
|
0.89 µg/mL
Interval 0.75 to 1.06
|
—
|
—
|
—
|
|
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
Anti-14 3 Mth post dose 3
|
2.40 µg/mL
Interval 2.07 to 2.79
|
2.42 µg/mL
Interval 2.09 to 2.8
|
—
|
—
|
—
|
|
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
Anti-18C 1 Mth post dose 2
|
11.33 µg/mL
Interval 9.39 to 13.68
|
10.88 µg/mL
Interval 8.98 to 13.18
|
—
|
—
|
—
|
|
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
Anti-18C 5 Mth post dose 2
|
3.00 µg/mL
Interval 2.54 to 3.53
|
3.18 µg/mL
Interval 2.71 to 3.74
|
—
|
—
|
—
|
|
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
Anti-18C 3 Mth post dose 3
|
18.38 µg/mL
Interval 15.94 to 21.19
|
16.24 µg/mL
Interval 14.11 to 18.69
|
—
|
—
|
—
|
|
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
Anti-19F 1 Mth post dose 2
|
7.33 µg/mL
Interval 6.17 to 8.71
|
7.85 µg/mL
Interval 6.61 to 9.32
|
—
|
—
|
—
|
|
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
Anti-19F 5 Mth post dose 2
|
2.38 µg/mL
Interval 2.07 to 2.74
|
2.48 µg/mL
Interval 2.12 to 2.9
|
—
|
—
|
—
|
|
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
Anti-19F 3 Mth post dose 3
|
5.99 µg/mL
Interval 5.13 to 7.01
|
6.27 µg/mL
Interval 5.36 to 7.32
|
—
|
—
|
—
|
|
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
Anti-23F 1 Mth post dose 2
|
0.63 µg/mL
Interval 0.51 to 0.78
|
0.67 µg/mL
Interval 0.53 to 0.84
|
—
|
—
|
—
|
|
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
Anti-23F 5 Mth post dose 2
|
0.44 µg/mL
Interval 0.37 to 0.52
|
0.46 µg/mL
Interval 0.39 to 0.55
|
—
|
—
|
—
|
|
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
Anti-23F 3 Mth post dose 3
|
1.46 µg/mL
Interval 1.24 to 1.72
|
1.50 µg/mL
Interval 1.27 to 1.76
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=189 Participants
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
n=192 Participants
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.
|
Synflorix 3+0d Group
n=195 Participants
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
n=192 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
Anti-3 1 Mth post dose 3
|
0.05 µg/mL
Interval 0.04 to 0.06
|
0.05 µg/mL
Interval 0.04 to 0.05
|
0.05 µg/mL
Interval 0.04 to 0.06
|
4.52 µg/mL
Interval 4.15 to 4.92
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
Anti-3 5 Mth post dose 3
|
0.06 µg/mL
Interval 0.05 to 0.07
|
0.06 µg/mL
Interval 0.05 to 0.08
|
0.07 µg/mL
Interval 0.06 to 0.09
|
0.60 µg/mL
Interval 0.52 to 0.68
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
Anti-3 8 Mth post dose 3
|
0.08 µg/mL
Interval 0.07 to 0.11
|
0.09 µg/mL
Interval 0.07 to 0.12
|
0.09 µg/mL
Interval 0.07 to 0.11
|
0.32 µg/mL
Interval 0.27 to 0.38
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
Anti-19A 1 Mth post dose 3
|
0.24 µg/mL
Interval 0.2 to 0.29
|
0.20 µg/mL
Interval 0.17 to 0.24
|
0.23 µg/mL
Interval 0.19 to 0.27
|
5.27 µg/mL
Interval 4.41 to 6.3
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
Anti-19A 5 Mth post dose 3
|
0.21 µg/mL
Interval 0.17 to 0.25
|
0.17 µg/mL
Interval 0.14 to 0.21
|
0.24 µg/mL
Interval 0.2 to 0.3
|
0.91 µg/mL
Interval 0.76 to 1.08
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
Anti-19A 8 Mth post dose 3
|
0.24 µg/mL
Interval 0.19 to 0.29
|
0.21 µg/mL
Interval 0.17 to 0.27
|
0.27 µg/mL
Interval 0.22 to 0.34
|
0.64 µg/mL
Interval 0.52 to 0.79
|
—
|
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=190 Participants
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
n=191 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
Anti-3 1 Mth post dose 2
|
0.04 µg/mL
Interval 0.04 to 0.05
|
0.05 µg/mL
Interval 0.04 to 0.06
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
Anti-3 5 Mth post dose 2
|
0.06 µg/mL
Interval 0.05 to 0.07
|
0.07 µg/mL
Interval 0.05 to 0.09
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
Anti-3 3 Mth post dose 3
|
0.07 µg/mL
Interval 0.06 to 0.09
|
0.08 µg/mL
Interval 0.06 to 0.1
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
Anti-19A 1 Mth post dose 2
|
0.24 µg/mL
Interval 0.2 to 0.29
|
0.25 µg/mL
Interval 0.2 to 0.3
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
Anti-19A 5 Mth post dose 2
|
0.18 µg/mL
Interval 0.15 to 0.22
|
0.19 µg/mL
Interval 0.15 to 0.24
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
Anti-19A 3 Mth post dose 3
|
0.56 µg/mL
Interval 0.43 to 0.71
|
0.64 µg/mL
Interval 0.5 to 0.81
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=190 Participants
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
n=192 Participants
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.
|
Synflorix 3+0d Group
n=192 Participants
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
n=190 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
Anti-6A 1Mth post dose 3
|
0.13 µg/mL
Interval 0.11 to 0.16
|
0.13 µg/mL
Interval 0.11 to 0.15
|
0.13 µg/mL
Interval 0.11 to 0.15
|
3.01 µg/mL
Interval 2.6 to 3.48
|
—
|
|
Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
Anti-6A 5 Mth post dose 3
|
0.17 µg/mL
Interval 0.14 to 0.2
|
0.15 µg/mL
Interval 0.13 to 0.18
|
0.22 µg/mL
Interval 0.18 to 0.27
|
1.0 µg/mL
Interval 0.89 to 1.13
|
—
|
|
Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
Anti-6A 8 Mth post dose 3
|
0.16 µg/mL
Interval 0.14 to 0.19
|
0.15 µg/mL
Interval 0.13 to 0.18
|
0.18 µg/mL
Interval 0.15 to 0.22
|
0.59 µg/mL
Interval 0.51 to 0.68
|
—
|
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=187 Participants
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
n=189 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
Anti-6A 1 Mth post dose 2
|
0.11 µg/mL
Interval 0.09 to 0.12
|
0.11 µg/mL
Interval 0.09 to 0.13
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
Anti-6A 5 Mth post-dose 2
|
0.10 µg/mL
Interval 0.09 to 0.12
|
0.12 µg/mL
Interval 0.1 to 0.14
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
Anti-6A 3 Mth post dose 3
|
0.14 µg/mL
Interval 0.12 to 0.16
|
0.15 µg/mL
Interval 0.12 to 0.17
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=93 Participants
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
n=96 Participants
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.
|
Synflorix 3+0d Group
n=98 Participants
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
n=96 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
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
OPSONO-1 1 Mth post dose 3
|
136.3 Titers
Interval 98.8 to 188.0
|
62.7 Titers
Interval 42.8 to 91.9
|
109.9 Titers
Interval 79.2 to 152.6
|
161.4 Titers
Interval 116.5 to 223.8
|
—
|
|
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
OPSONO-1 5 Mth post dose 3
|
14.1 Titers
Interval 9.9 to 20.0
|
10.1 Titers
Interval 7.4 to 13.8
|
11.0 Titers
Interval 7.9 to 15.3
|
14.3 Titers
Interval 9.9 to 20.4
|
—
|
|
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
OPSONO-1 8 Mth post dose 3
|
10.0 Titers
Interval 7.3 to 13.6
|
8.4 Titers
Interval 6.4 to 11.0
|
9.3 Titers
Interval 6.9 to 12.5
|
12.5 Titers
Interval 8.8 to 17.6
|
—
|
|
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
OPSONO-4 1 Mth post dose 3
|
835.0 Titers
Interval 657.1 to 1061.0
|
784.0 Titers
Interval 633.1 to 970.8
|
715.6 Titers
Interval 586.5 to 873.2
|
1022.7 Titers
Interval 839.6 to 1245.7
|
—
|
|
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
OPSONO-4 5 Mth post dose 3
|
86.0 Titers
Interval 58.5 to 126.4
|
48.2 Titers
Interval 31.5 to 73.7
|
54.7 Titers
Interval 37.2 to 80.4
|
62.8 Titers
Interval 40.0 to 98.4
|
—
|
|
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
OPSONO-4 8 Mth post dose 3
|
48.2 Titers
Interval 31.0 to 74.9
|
34.3 Titers
Interval 21.8 to 53.9
|
41.7 Titers
Interval 27.4 to 63.7
|
41.8 Titers
Interval 25.9 to 67.5
|
—
|
|
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
OPSONO-5 1 Mth post dose 3
|
97.9 Titers
Interval 75.5 to 127.0
|
51.4 Titers
Interval 37.8 to 70.1
|
76.7 Titers
Interval 58.5 to 100.6
|
91.5 Titers
Interval 69.7 to 120.2
|
—
|
|
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
OPSONO-5 5 Mth post dose 3
|
19.7 Titers
Interval 14.9 to 26.1
|
13.1 Titers
Interval 10.0 to 17.3
|
16.2 Titers
Interval 12.1 to 21.5
|
17.4 Titers
Interval 13.2 to 23.0
|
—
|
|
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
OPSONO-5 8 Mth post dose 3
|
9.4 Titers
Interval 7.4 to 11.9
|
8.3 Titers
Interval 6.5 to 10.5
|
11.2 Titers
Interval 8.7 to 14.2
|
10.8 Titers
Interval 8.5 to 13.6
|
—
|
|
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
OPSONO-6B 1 Mth post dose 3
|
827.6 Titers
Interval 601.4 to 1138.9
|
432.8 Titers
Interval 293.1 to 638.8
|
814.6 Titers
Interval 594.1 to 1116.9
|
1317.6 Titers
Interval 937.1 to 1852.6
|
—
|
|
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
OPSONO-6B 5 Mth post dose 3
|
242.4 Titers
Interval 158.9 to 369.9
|
251.3 Titers
Interval 169.1 to 373.4
|
324.0 Titers
Interval 227.2 to 461.9
|
90.9 Titers
Interval 53.3 to 155.0
|
—
|
|
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
OPSONO-6B 8 Mth post dose 3
|
146.9 Titers
Interval 95.9 to 225.1
|
126.0 Titers
Interval 80.4 to 197.4
|
233.1 Titers
Interval 160.7 to 338.1
|
73.7 Titers
Interval 43.3 to 125.4
|
—
|
|
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
OPSONO-7F 1 Mth post dose 3
|
3755.3 Titers
Interval 3060.5 to 4607.9
|
2993.3 Titers
Interval 2440.1 to 3672.0
|
3767.9 Titers
Interval 2981.2 to 4762.1
|
7241.0 Titers
Interval 5923.2 to 8852.1
|
—
|
|
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
OPSONO-7F 5 Mth post dose 3
|
2072.1 Titers
Interval 1634.8 to 2626.3
|
1850.6 Titers
Interval 1454.8 to 2354.1
|
1710.3 Titers
Interval 1329.7 to 2199.9
|
3652.1 Titers
Interval 2878.1 to 4634.2
|
—
|
|
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
OPSONO-7F 8 Mth post dose 3
|
2001.5 Titers
Interval 1629.3 to 2458.7
|
2313.0 Titers
Interval 1851.4 to 2889.8
|
2291.2 Titers
Interval 1903.9 to 2757.3
|
3054.1 Titers
Interval 2502.7 to 3727.0
|
—
|
|
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
OPSONO-9V 1 Mth post dose 3
|
909.2 Titers
Interval 722.3 to 1144.5
|
1113.1 Titers
Interval 888.0 to 1395.3
|
1044.6 Titers
Interval 788.6 to 1383.6
|
878.3 Titers
Interval 647.7 to 1191.0
|
—
|
|
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
OPSONO-9V 5 Mth post dose 3
|
360.3 Titers
Interval 253.2 to 512.7
|
449.2 Titers
Interval 347.2 to 581.3
|
320.1 Titers
Interval 236.2 to 433.6
|
342.8 Titers
Interval 240.3 to 489.0
|
—
|
|
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
OPSONO-9V 8 Mth post dose 3
|
330.6 Titers
Interval 230.2 to 474.9
|
436.7 Titers
Interval 322.5 to 591.4
|
277.0 Titers
Interval 196.1 to 391.4
|
308.6 Titers
Interval 216.6 to 439.7
|
—
|
|
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
OPSONO-14 1 Mth post dose 3
|
1176.2 Titers
Interval 823.1 to 1680.9
|
1169.8 Titers
Interval 845.3 to 1618.9
|
1139.9 Titers
Interval 773.2 to 1680.4
|
2504.7 Titers
Interval 1665.7 to 3766.3
|
—
|
|
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
OPSONO-14 5 Mth post dose 3
|
188.9 Titers
Interval 129.7 to 275.0
|
181.3 Titers
Interval 125.6 to 261.5
|
233.4 Titers
Interval 160.2 to 340.1
|
499.3 Titers
Interval 350.5 to 711.1
|
—
|
|
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
OPSONO-14 8 Mth post dose 3
|
152.9 Titers
Interval 103.0 to 227.1
|
186.9 Titers
Interval 130.5 to 267.6
|
223.1 Titers
Interval 159.0 to 313.2
|
371.0 Titers
Interval 257.6 to 534.2
|
—
|
|
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
OPSONO-18C 1 Mth post dose 3
|
666.2 Titers
Interval 542.9 to 817.6
|
532.0 Titers
Interval 413.8 to 683.9
|
623.6 Titers
Interval 493.1 to 788.6
|
277.7 Titers
Interval 209.9 to 367.5
|
—
|
|
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
OPSONO-18C 5 Mth post dose 3
|
39.8 Titers
Interval 29.4 to 54.0
|
32.0 Titers
Interval 22.9 to 44.6
|
44.1 Titers
Interval 32.7 to 59.5
|
9.1 Titers
Interval 7.0 to 11.8
|
—
|
|
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
OPSONO-18C 8 Mth post dose 3
|
13.6 Titers
Interval 10.2 to 18.1
|
11.7 Titers
Interval 9.0 to 15.1
|
16.9 Titers
Interval 12.8 to 22.4
|
6.5 Titers
Interval 5.0 to 8.3
|
—
|
|
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
OPSONO-19F 1 Mth post dose 3
|
420.3 Titers
Interval 307.6 to 574.2
|
340.6 Titers
Interval 242.7 to 478.0
|
518.3 Titers
Interval 389.1 to 690.4
|
84.8 Titers
Interval 66.1 to 108.9
|
—
|
|
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
OPSONO-19F 5 Mth post dose 3
|
47.2 Titers
Interval 35.3 to 62.9
|
30.7 Titers
Interval 22.8 to 41.4
|
66.9 Titers
Interval 49.3 to 90.9
|
7.2 Titers
Interval 5.4 to 9.5
|
—
|
|
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
OPSONO-19F 8 Mth post dose 3
|
22.0 Titers
Interval 16.3 to 29.6
|
20.3 Titers
Interval 14.6 to 28.5
|
32.5 Titers
Interval 23.6 to 44.7
|
7.0 Titers
Interval 5.4 to 9.2
|
—
|
|
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
OPSONO-23F 1 Mth post dose 3
|
1421.3 Titers
Interval 976.4 to 2068.9
|
965.1 Titers
Interval 622.7 to 1495.8
|
1030.2 Titers
Interval 693.0 to 1531.4
|
2821.9 Titers
Interval 1913.1 to 4162.3
|
—
|
|
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
OPSONO-23F 5 Mth post dose 3
|
307.4 Titers
Interval 183.0 to 516.3
|
387.1 Titers
Interval 234.4 to 639.1
|
239.5 Titers
Interval 140.2 to 409.1
|
638.6 Titers
Interval 369.2 to 1104.6
|
—
|
|
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
OPSONO-23F 8 Mth post dose 3
|
306.2 Titers
Interval 172.3 to 543.9
|
385.9 Titers
Interval 221.1 to 673.5
|
410.8 Titers
Interval 246.7 to 684.2
|
650.4 Titers
Interval 367.1 to 1152.3
|
—
|
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=98 Participants
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
n=97 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
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
OPSONO-1 1 Mth post dose 2
|
67.3 Titers
Interval 46.5 to 97.4
|
58.0 Titers
Interval 40.4 to 83.4
|
—
|
—
|
—
|
|
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
OPSONO-1 5 Mth post dose 2
|
7.7 Titers
Interval 6.0 to 9.8
|
8.1 Titers
Interval 6.1 to 10.7
|
—
|
—
|
—
|
|
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
OPSONO-1 3 Mth post dose 3
|
58.8 Titers
Interval 38.2 to 90.7
|
57.5 Titers
Interval 37.8 to 87.5
|
—
|
—
|
—
|
|
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
OPSONO-4 1 Mth post dose 2
|
461.9 Titers
Interval 377.9 to 564.5
|
427.2 Titers
Interval 327.0 to 558.0
|
—
|
—
|
—
|
|
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
OPSONO-4 5 Mth post dose 2
|
27.0 Titers
Interval 18.6 to 39.2
|
27.4 Titers
Interval 18.6 to 40.4
|
—
|
—
|
—
|
|
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
OPSONO-4 3 Mth post dose 3
|
260.0 Titers
Interval 190.0 to 355.8
|
241.1 Titers
Interval 170.4 to 341.0
|
—
|
—
|
—
|
|
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
OPSONO-5 1 Mth post dose 2
|
49.1 Titers
Interval 37.0 to 65.0
|
49.1 Titers
Interval 36.2 to 66.6
|
—
|
—
|
—
|
|
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
OPSONO-5 5 Mth post dose 2
|
11.8 Titers
Interval 9.3 to 15.1
|
12.6 Titers
Interval 9.7 to 16.4
|
—
|
—
|
—
|
|
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
OPSONO-5 3 Mth post dose 3
|
58.2 Titers
Interval 44.0 to 77.0
|
47.0 Titers
Interval 34.4 to 64.2
|
—
|
—
|
—
|
|
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
OPSONO-6B 1 Mth post dose 2
|
359.8 Titers
Interval 240.2 to 539.0
|
331.7 Titers
Interval 223.1 to 493.2
|
—
|
—
|
—
|
|
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
OPSONO-6B 5 Mth post dose 2
|
159.1 Titers
Interval 102.0 to 248.0
|
111.1 Titers
Interval 68.3 to 180.7
|
—
|
—
|
—
|
|
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
OPSONO-6B 3 Mth post dose 3
|
214.7 Titers
Interval 146.2 to 315.1
|
192.0 Titers
Interval 130.0 to 283.6
|
—
|
—
|
—
|
|
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
OPSONO-7F 1 Mth post dose 2
|
2643.3 Titers
Interval 2122.6 to 3291.6
|
2336.3 Titers
Interval 1923.9 to 2837.3
|
—
|
—
|
—
|
|
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
OPSONO-7F 5 Mth post dose 2
|
1258.2 Titers
Interval 972.6 to 1627.6
|
1466.4 Titers
Interval 1150.1 to 1869.7
|
—
|
—
|
—
|
|
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
OPSONO-7F 3 Mth post dose 3
|
2767.6 Titers
Interval 2261.7 to 3386.7
|
2963.6 Titers
Interval 2379.0 to 3691.9
|
—
|
—
|
—
|
|
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
OPSONO-9V 1 Mth post dose 2
|
783.7 Titers
Interval 609.0 to 1008.5
|
763.2 Titers
Interval 625.4 to 931.4
|
—
|
—
|
—
|
|
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
OPSONO-9V 5 Mth post dose 2
|
241.3 Titers
Interval 159.0 to 366.2
|
163.3 Titers
Interval 113.8 to 234.3
|
—
|
—
|
—
|
|
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
OPSONO-9V 3 Mth post dose 3
|
1044.3 Titers
Interval 818.8 to 1332.0
|
712.4 Titers
Interval 534.2 to 950.0
|
—
|
—
|
—
|
|
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
OPSONO-14 1 Mth post dose 2
|
349.7 Titers
Interval 231.7 to 527.8
|
310.5 Titers
Interval 200.1 to 481.9
|
—
|
—
|
—
|
|
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
OPSONO-14 5 Mth post dose 2
|
54.3 Titers
Interval 35.5 to 83.0
|
40.2 Titers
Interval 26.6 to 60.8
|
—
|
—
|
—
|
|
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
OPSONO-14 3 Mth post dose 3
|
335.9 Titers
Interval 257.2 to 438.7
|
254.6 Titers
Interval 180.4 to 359.4
|
—
|
—
|
—
|
|
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
OPSONO-18C 1 Mth post dose 2
|
464.7 Titers
Interval 317.0 to 681.2
|
459.7 Titers
Interval 330.7 to 639.1
|
—
|
—
|
—
|
|
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
OPSONO-18C 5 Mth post dose 2
|
28.4 Titers
Interval 20.3 to 39.7
|
33.6 Titers
Interval 23.5 to 47.8
|
—
|
—
|
—
|
|
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
OPSONO-18C 3 Mth post dose 3
|
562.8 Titers
Interval 405.0 to 782.0
|
522.0 Titers
Interval 390.0 to 698.7
|
—
|
—
|
—
|
|
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
OPSONO-19F 1 Mth post dose 2
|
299.3 Titers
Interval 213.5 to 419.6
|
284.7 Titers
Interval 201.1 to 403.1
|
—
|
—
|
—
|
|
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
OPSONO-19F 5 Mth post dose 2
|
35.5 Titers
Interval 26.0 to 48.3
|
38.7 Titers
Interval 27.6 to 54.3
|
—
|
—
|
—
|
|
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
OPSONO-19F 3 Mth post dose 3
|
203.6 Titers
Interval 140.5 to 295.1
|
168.1 Titers
Interval 110.0 to 256.8
|
—
|
—
|
—
|
|
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
OPSONO-23F 1 Mth post dose 2
|
539.6 Titers
Interval 343.1 to 848.6
|
493.9 Titers
Interval 308.8 to 789.8
|
—
|
—
|
—
|
|
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
OPSONO-23F 5 Mth post dose 2
|
156.5 Titers
Interval 88.7 to 276.3
|
158.6 Titers
Interval 91.1 to 276.1
|
—
|
—
|
—
|
|
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
OPSONO-23F 3 Mth post dose 3
|
612.2 Titers
Interval 395.6 to 947.4
|
835.7 Titers
Interval 548.1 to 1274.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=92 Participants
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
n=94 Participants
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.
|
Synflorix 3+0d Group
n=97 Participants
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
n=96 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
OPSONO-3 5 Mth post dose 3
|
7.1 Titers
Interval 5.6 to 9.0
|
5.5 Titers
Interval 4.5 to 6.6
|
6.7 Titers
Interval 5.3 to 8.5
|
15.1 Titers
Interval 11.0 to 20.6
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
OPSONO-6A 1 Mth post dose 3
|
13.7 Titers
Interval 9.0 to 20.9
|
11.8 Titers
Interval 8.0 to 17.4
|
11.3 Titers
Interval 7.7 to 16.5
|
2770.0 Titers
Interval 2216.1 to 3462.4
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
OPSONO-6A 5 Mth post dose 3
|
14.8 Titers
Interval 9.5 to 23.2
|
12.0 Titers
Interval 8.0 to 17.9
|
20.2 Titers
Interval 12.7 to 32.0
|
602.0 Titers
Interval 433.4 to 836.2
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
OPSONO-3 8 Mth post dose 3
|
8.1 Titers
Interval 6.3 to 10.5
|
8.3 Titers
Interval 6.3 to 11.0
|
7.8 Titers
Interval 6.1 to 10.1
|
12.3 Titers
Interval 9.0 to 16.7
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
OPSONO-3 1 Mth post dose 3
|
5.3 Titers
Interval 4.3 to 6.4
|
4.5 Titers
Interval 4.0 to 5.1
|
4.8 Titers
Interval 4.2 to 5.5
|
98.3 Titers
Interval 82.8 to 116.7
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
OPSONO-6A 8 Mth post dose 3
|
14.8 Titers
Interval 9.4 to 23.3
|
12.4 Titers
Interval 8.1 to 19.1
|
18.5 Titers
Interval 11.7 to 29.3
|
260.1 Titers
Interval 167.4 to 404.2
|
—
|
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=96 Participants
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
n=97 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
OPSONO-6A 3 Mth post dose 3
|
12.6 Titers
Interval 8.3 to 19.2
|
10.0 Titers
Interval 6.7 to 15.0
|
—
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
OPSONO-3 1 Mth post dose 2
|
4.7 Titers
Interval 4.2 to 5.4
|
5.1 Titers
Interval 4.2 to 6.1
|
—
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
OPSONO-3 5 Mth post dose 2
|
5.9 Titers
Interval 4.8 to 7.3
|
5.9 Titers
Interval 4.6 to 7.6
|
—
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
OPSONO-3 3 Mth post dose 3
|
7.4 Titers
Interval 5.7 to 9.6
|
6.8 Titers
Interval 5.4 to 8.4
|
—
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
OPSONO-6A 1 Mth post dose 2
|
6.7 Titers
Interval 5.1 to 8.8
|
6.7 Titers
Interval 5.1 to 8.7
|
—
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
OPSONO-6A 5 Mth post dose 2
|
12.4 Titers
Interval 8.4 to 18.3
|
12.2 Titers
Interval 8.2 to 18.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) to the serotype-specific Lower Limit of Quantification ( = 143). This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=71 Participants
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
n=79 Participants
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.
|
Synflorix 3+0d Group
n=71 Participants
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
n=89 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
OPSONO-19A 1 Mth post dose 3
|
347.0 Titers
Interval 238.0 to 505.9
|
281.1 Titers
Interval 192.8 to 409.8
|
369.8 Titers
Interval 257.5 to 531.0
|
2652.8 Titers
Interval 2277.5 to 3089.9
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
OPSONO-19A 5 Mth post dose 3
|
120.4 Titers
Interval 91.9 to 157.8
|
121.6 Titers
Interval 94.3 to 156.8
|
140.2 Titers
Interval 102.1 to 192.4
|
704.2 Titers
Interval 498.5 to 994.8
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
OPSONO-19A 8 Mth post dose 3
|
155.2 Titers
Interval 109.1 to 220.9
|
151.5 Titers
Interval 110.0 to 208.7
|
138.7 Titers
Interval 101.3 to 190.0
|
394.4 Titers
Interval 261.8 to 594.2
|
—
|
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) to the serotype-specific Lower Limit of Quantification ( = 143). This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=72 Participants
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
n=81 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
OPSONO-19A 1 Mth post dose 2
|
231.3 Titers
Interval 164.5 to 325.4
|
177.4 Titers
Interval 129.4 to 243.2
|
—
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
OPSONO-19A 5 Mth post dose 2
|
99.1 Titers
Interval 80.0 to 122.7
|
107.4 Titers
Interval 84.5 to 136.5
|
—
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
OPSONO-19A 3 Mth post dose 3
|
274.2 Titers
Interval 187.6 to 400.8
|
361.2 Titers
Interval 247.5 to 527.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
No analysis was performed on opsonophagocytic activity for Antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.
Outcome measures
| Measure |
10PP-HD 1d Group
n=99 Participants
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
n=99 Participants
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.
|
Synflorix 3+0d Group
n=98 Participants
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
n=99 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Anti-D 1 Mth post dose 3
|
2.499 IU/mL
Interval 2.111 to 2.959
|
2.696 IU/mL
Interval 2.381 to 3.053
|
2.874 IU/mL
Interval 2.524 to 3.272
|
1.531 IU/mL
Interval 1.33 to 1.762
|
—
|
|
Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Anti-T 1 Mth post dose 3
|
4.977 IU/mL
Interval 4.127 to 6.002
|
5.113 IU/mL
Interval 4.294 to 6.089
|
4.709 IU/mL
Interval 3.994 to 5.551
|
4.047 IU/mL
Interval 3.462 to 4.731
|
—
|
SECONDARY outcome
Timeframe: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.
Outcome measures
| Measure |
10PP-HD 1d Group
n=95 Participants
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
n=96 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Anti-D 1 Mth post dose 2
|
2.591 IU/mL
Interval 2.213 to 3.033
|
2.560 IU/mL
Interval 2.207 to 2.969
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Anti-T 1 Mth post dose 2
|
5.714 IU/mL
Interval 4.816 to 6.781
|
4.738 IU/mL
Interval 3.905 to 5.749
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.
Outcome measures
| Measure |
10PP-HD 1d Group
n=99 Participants
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
n=99 Participants
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.
|
Synflorix 3+0d Group
n=98 Participants
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
n=99 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
|
111.9 EL.U/mL
Interval 99.4 to 125.8
|
110.3 EL.U/mL
Interval 99.3 to 122.5
|
105.8 EL.U/mL
Interval 94.4 to 118.6
|
117.0 EL.U/mL
Interval 105.0 to 130.3
|
—
|
SECONDARY outcome
Timeframe: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.
Outcome measures
| Measure |
10PP-HD 1d Group
n=94 Participants
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
n=96 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
|
123.2 EL.U/mL
Interval 112.0 to 135.5
|
114.7 EL.U/mL
Interval 101.3 to 129.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.
Outcome measures
| Measure |
10PP-HD 1d Group
n=99 Participants
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
n=99 Participants
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.
|
Synflorix 3+0d Group
n=98 Participants
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
n=99 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
|
23.381 µg/mL
Interval 19.326 to 28.287
|
19.397 µg/mL
Interval 15.319 to 24.561
|
19.239 µg/mL
Interval 15.085 to 24.537
|
18.981 µg/mL
Interval 15.244 to 23.635
|
—
|
SECONDARY outcome
Timeframe: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.
Outcome measures
| Measure |
10PP-HD 1d Group
n=95 Participants
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
n=96 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
|
21.274 µg/mL
Interval 17.909 to 25.272
|
21.150 µg/mL
Interval 17.427 to 25.669
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.
Outcome measures
| Measure |
10PP-HD 1d Group
n=94 Participants
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
n=93 Participants
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.
|
Synflorix 3+0d Group
n=91 Participants
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
n=89 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
|
1235.8 mIU/mL
Interval 946.9 to 1612.9
|
1165.8 mIU/mL
Interval 910.7 to 1492.3
|
990.1 mIU/mL
Interval 757.6 to 1294.0
|
1206.6 mIU/mL
Interval 946.2 to 1538.7
|
—
|
SECONDARY outcome
Timeframe: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.
Outcome measures
| Measure |
10PP-HD 1d Group
n=89 Participants
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
n=88 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
|
1318.5 mIU/mL
Interval 1062.5 to 1636.3
|
976.5 mIU/mL
Interval 724.2 to 1316.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8.
Outcome measures
| Measure |
10PP-HD 1d Group
n=97 Participants
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
n=92 Participants
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.
|
Synflorix 3+0d Group
n=91 Participants
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
n=94 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
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
Anti-Polio 1 - 1 Mth post dose 3
|
413.2 Titers
Interval 287.0 to 594.9
|
314.8 Titers
Interval 202.7 to 488.7
|
447.9 Titers
Interval 278.5 to 720.1
|
398.3 Titers
Interval 256.6 to 618.3
|
—
|
|
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
Anti-Polio 2 - 1 Mth post dose 3
|
545.8 Titers
Interval 371.6 to 801.6
|
619.5 Titers
Interval 462.0 to 830.7
|
514.2 Titers
Interval 353.8 to 747.2
|
536.9 Titers
Interval 400.6 to 719.6
|
—
|
|
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
Anti-Polio 3 - 1 Mth post dose 3
|
135.4 Titers
Interval 91.5 to 200.5
|
166.0 Titers
Interval 124.5 to 221.5
|
110.1 Titers
Interval 72.5 to 167.2
|
191.8 Titers
Interval 129.4 to 284.4
|
—
|
SECONDARY outcome
Timeframe: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8.
Outcome measures
| Measure |
10PP-HD 1d Group
n=87 Participants
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
n=93 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
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
Anti-Polio 1 - 1 Mth post dose 2
|
330.3 Titers
Interval 208.6 to 523.0
|
415.6 Titers
Interval 286.7 to 602.6
|
—
|
—
|
—
|
|
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
Anti-Polio 2 - 1 Mth post dose 2
|
486.7 Titers
Interval 319.7 to 741.1
|
702.9 Titers
Interval 529.6 to 932.8
|
—
|
—
|
—
|
|
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
Anti-Polio 3 - 1 Mth post dose 2
|
106.9 Titers
Interval 71.8 to 159.1
|
181.1 Titers
Interval 131.7 to 249.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL.
Outcome measures
| Measure |
10PP-HD 1d Group
n=90 Participants
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
n=95 Participants
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.
|
Synflorix 3+0d Group
n=96 Participants
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
n=86 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
|
329.2 mIU/mL
Interval 272.6 to 397.5
|
298.6 mIU/mL
Interval 254.9 to 349.8
|
295.8 mIU/mL
Interval 237.2 to 368.8
|
274.1 mIU/mL
Interval 227.7 to 330.0
|
—
|
SECONDARY outcome
Timeframe: At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL.
Outcome measures
| Measure |
10PP-HD 1d Group
n=96 Participants
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
n=94 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
|
284.5 mIU/mL
Interval 240.9 to 336.0
|
305.9 mIU/mL
Interval 256.5 to 364.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10.
Outcome measures
| Measure |
10PP-HD 1d Group
n=97 Participants
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
n=95 Participants
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.
|
Synflorix 3+0d Group
n=97 Participants
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
n=98 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
|
334.0 Titers
Interval 250.6 to 445.1
|
264.7 Titers
Interval 201.0 to 348.5
|
379.9 Titers
Interval 293.2 to 492.2
|
306.7 Titers
Interval 242.9 to 387.3
|
—
|
SECONDARY outcome
Timeframe: At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10.
Outcome measures
| Measure |
10PP-HD 1d Group
n=94 Participants
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
n=95 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
|
342.0 Titers
Interval 252.2 to 463.7
|
239.0 Titers
Interval 176.0 to 324.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=200 Participants
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
n=200 Participants
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.
|
Synflorix 3+0d Group
n=200 Participants
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
n=200 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule.
Any pain
|
108 Participants
|
121 Participants
|
123 Participants
|
115 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule.
Grade 3 pain
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule.
Any redness
|
8 Participants
|
7 Participants
|
9 Participants
|
5 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule.
Grade 3 redness
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule.
Any swelling
|
30 Participants
|
45 Participants
|
40 Participants
|
37 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule.
Grade 3 swelling
|
7 Participants
|
10 Participants
|
17 Participants
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=200 Participants
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
n=200 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.
Any pain
|
97 Participants
|
102 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.
Grade 3 pain
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.
Any redness
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.
Grade 3 redness
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.
Any swelling
|
35 Participants
|
31 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.
Grade 3 swelling
|
9 Participants
|
4 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=191 Participants
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
n=195 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.
Grade 3 redness
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.
Any pain
|
21 Participants
|
26 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.
Grade 3 pain
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.
Any redness
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.
Any swelling
|
4 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.
Grade 3 swelling
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than \[≥\] 37.5 degrees Celsius \[°C\]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (\>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=200 Participants
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
n=200 Participants
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.
|
Synflorix 3+0d Group
n=200 Participants
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
n=200 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
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
Any Drowsiness
|
43 Participants
|
46 Participants
|
38 Participants
|
44 Participants
|
—
|
|
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
Grade 3 Drowsiness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
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
Related Drowsiness
|
43 Participants
|
45 Participants
|
38 Participants
|
43 Participants
|
—
|
|
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
Any Irritability/fussiness
|
139 Participants
|
133 Participants
|
141 Participants
|
136 Participants
|
—
|
|
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
Grade 3 Irritability/fussiness
|
6 Participants
|
4 Participants
|
4 Participants
|
7 Participants
|
—
|
|
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
Related Irritability/fussiness
|
138 Participants
|
132 Participants
|
138 Participants
|
136 Participants
|
—
|
|
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
Any Loss of appetite
|
32 Participants
|
30 Participants
|
27 Participants
|
34 Participants
|
—
|
|
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
Grade 3 Loss of appetite
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
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
Related Loss of appetite
|
32 Participants
|
29 Participants
|
26 Participants
|
34 Participants
|
—
|
|
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
Any Fever
|
104 Participants
|
100 Participants
|
105 Participants
|
106 Participants
|
—
|
|
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
Grade 3 Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
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
Related Fever
|
102 Participants
|
100 Participants
|
104 Participants
|
104 Participants
|
—
|
SECONDARY outcome
Timeframe: Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than \[≥\] 37.5 degrees Celsius \[°C\]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (\>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=200 Participants
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
n=200 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
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
Any Drowsiness
|
47 Participants
|
44 Participants
|
—
|
—
|
—
|
|
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
Grade 3 Drowsiness
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
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
Related Drowsiness
|
46 Participants
|
43 Participants
|
—
|
—
|
—
|
|
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
Any Fever
|
92 Participants
|
84 Participants
|
—
|
—
|
—
|
|
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
Grade 3 Fever
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
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
Related Fever
|
89 Participants
|
84 Participants
|
—
|
—
|
—
|
|
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
Any Irritability/fussiness
|
131 Participants
|
128 Participants
|
—
|
—
|
—
|
|
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
Grade 3 Irritability/fussiness
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
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
Related Irritability/fussiness
|
128 Participants
|
126 Participants
|
—
|
—
|
—
|
|
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
Any Loss of appetite
|
24 Participants
|
25 Participants
|
—
|
—
|
—
|
|
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
Grade 3 Loss of appetite
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
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
Related Loss of appetite
|
24 Participants
|
24 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than \[≥\] 37.5 degrees Celsius \[°C\]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (\>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=191 Participants
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
n=195 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
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
Any Drowsiness
|
12 Participants
|
4 Participants
|
—
|
—
|
—
|
|
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
Grade 3 Drowsiness
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
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
Related Drowsiness
|
12 Participants
|
4 Participants
|
—
|
—
|
—
|
|
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
Any Fever
|
32 Participants
|
27 Participants
|
—
|
—
|
—
|
|
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
Grade 3 Fever
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
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
Related Fever
|
30 Participants
|
25 Participants
|
—
|
—
|
—
|
|
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
Any Irritability/fussiness
|
27 Participants
|
19 Participants
|
—
|
—
|
—
|
|
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
Grade 3 Irritability/fussiness
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
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
Related Irritability/fussiness
|
27 Participants
|
19 Participants
|
—
|
—
|
—
|
|
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
Any Loss of appetite
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
|
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
Grade 3 Loss of appetite
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
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
Related Loss of appetite
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within the 31-day (Days 0-30) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=200 Participants
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
n=200 Participants
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.
|
Synflorix 3+0d Group
n=200 Participants
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
n=200 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule
|
113 Participants
|
114 Participants
|
123 Participants
|
114 Participants
|
—
|
SECONDARY outcome
Timeframe: Within the 31-day (Days 0-30) periods post vaccination with the first 2 doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=200 Participants
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
n=200 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule
|
84 Participants
|
95 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within the 31-day (Days 0-30) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=191 Participants
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
n=195 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Month 10Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=200 Participants
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
n=200 Participants
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.
|
Synflorix 3+0d Group
n=200 Participants
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
n=200 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule
|
1 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Month 10Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=200 Participants
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
n=200 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=193 Participants
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
n=194 Participants
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.
|
Synflorix 3+0d Group
n=196 Participants
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
n=196 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 1 Mth post dose 3
|
165 Participants
|
158 Participants
|
166 Participants
|
155 Participants
|
—
|
|
Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 5 Mth post dose 3
|
166 Participants
|
161 Participants
|
176 Participants
|
168 Participants
|
—
|
|
Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 8 Mth post dose 3
|
174 Participants
|
166 Participants
|
174 Participants
|
171 Participants
|
—
|
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=197 Participants
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
n=197 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 1 Mth post-dose 2
|
159 Participants
|
162 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 5 Mth post-dose 2
|
164 Participants
|
173 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 3 Mth post-dose 3
|
178 Participants
|
176 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (S. pn). vaccine pneumococcal serotype was defined as any of the pneumococcal S. pn. vaccine serotypes, e. a. serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=193 Participants
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
n=194 Participants
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.
|
Synflorix 3+0d Group
n=196 Participants
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
n=196 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 1 Mth post dose 3
|
24 Participants
|
31 Participants
|
34 Participants
|
29 Participants
|
—
|
|
Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 5 Mth post dose 3
|
25 Participants
|
23 Participants
|
28 Participants
|
30 Participants
|
—
|
|
Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 8 Mth post dose 3
|
24 Participants
|
15 Participants
|
16 Participants
|
21 Participants
|
—
|
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (S. pn). vaccine pneumococcal serotype was defined as any of the pneumococcal S. pn. vaccine serotypes, e. a. serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=197 Participants
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
n=197 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 1 Mth post-dose 2
|
27 Participants
|
24 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 5 Mth post-dose 2
|
24 Participants
|
23 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 3 Mth post-dose 3
|
18 Participants
|
19 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=193 Participants
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
n=194 Participants
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.
|
Synflorix 3+0d Group
n=196 Participants
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
n=196 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 1 Mth post dose 3
|
57 Participants
|
56 Participants
|
60 Participants
|
48 Participants
|
—
|
|
Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 5 Mth post dose 3
|
54 Participants
|
48 Participants
|
58 Participants
|
46 Participants
|
—
|
|
Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 8 Mth post dose 3
|
45 Participants
|
42 Participants
|
47 Participants
|
42 Participants
|
—
|
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=197 Participants
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
n=197 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 1 Mth post-dose 2
|
62 Participants
|
50 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 5 Mth post-dose 2
|
45 Participants
|
49 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 3 Mth post-dose 3
|
58 Participants
|
52 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=193 Participants
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
n=194 Participants
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.
|
Synflorix 3+0d Group
n=195 Participants
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
n=196 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 1 Mth post dose 3
|
29 Participants
|
33 Participants
|
28 Participants
|
37 Participants
|
—
|
|
Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 5 Mth post dose 3
|
27 Participants
|
28 Participants
|
28 Participants
|
30 Participants
|
—
|
|
Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 8 Mth post dose 3
|
9 Participants
|
13 Participants
|
12 Participants
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=197 Participants
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
n=197 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 3 Mth post-dose 3
|
9 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 1 Mth post-dose 2
|
26 Participants
|
23 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 5 Mth post-dose 2
|
20 Participants
|
32 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=193 Participants
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
n=194 Participants
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.
|
Synflorix 3+0d Group
n=196 Participants
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
n=196 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 1 Mth post dose 3
|
88 Participants
|
98 Participants
|
104 Participants
|
100 Participants
|
—
|
|
Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 5 Mth post dose 3
|
72 Participants
|
73 Participants
|
78 Participants
|
88 Participants
|
—
|
|
Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 8 Mth post dose 3
|
74 Participants
|
67 Participants
|
70 Participants
|
74 Participants
|
—
|
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=197 Participants
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
n=197 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 1 Mth post-dose 2
|
86 Participants
|
93 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 5 Mth post-dose 2
|
73 Participants
|
84 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 3 Mth post-dose 3
|
56 Participants
|
83 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed.This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=193 Participants
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
n=194 Participants
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.
|
Synflorix 3+0d Group
n=196 Participants
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
n=196 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 1 Mth post dose 3
|
5 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 5 Mth post dose 3
|
4 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 8 Mth post dose 3
|
4 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=197 Participants
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
n=197 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 1 Mth post-dose 2
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 5 Mth post-dose 2
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 3 Mth post-dose 3
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=193 Participants
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
n=194 Participants
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.
|
Synflorix 3+0d Group
n=196 Participants
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
n=196 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 1 Mth post dose 3
|
44 Participants
|
44 Participants
|
54 Participants
|
50 Participants
|
—
|
|
Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 5 Mth post dose 3
|
36 Participants
|
37 Participants
|
39 Participants
|
37 Participants
|
—
|
|
Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 8 Mth post dose 3
|
13 Participants
|
17 Participants
|
25 Participants
|
11 Participants
|
—
|
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=197 Participants
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
n=197 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 1 Mth post-dose 2
|
46 Participants
|
62 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 5 Mth post-dose 2
|
32 Participants
|
40 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 3 Mth post-dose 3
|
21 Participants
|
17 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=193 Participants
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
n=194 Participants
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.
|
Synflorix 3+0d Group
n=196 Participants
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
n=196 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 5 Mth post dose 3
|
108 Participants
|
122 Participants
|
131 Participants
|
126 Participants
|
—
|
|
Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 8 Mth post dose 3
|
121 Participants
|
115 Participants
|
122 Participants
|
122 Participants
|
—
|
|
Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 1 Mth post dose 3
|
124 Participants
|
106 Participants
|
120 Participants
|
112 Participants
|
—
|
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=197 Participants
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
n=197 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 1 Mth post-dose 2
|
117 Participants
|
128 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 5 Mth post-dose 2
|
119 Participants
|
138 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 3 Mth post-dose 3
|
129 Participants
|
117 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=193 Participants
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
n=194 Participants
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.
|
Synflorix 3+0d Group
n=196 Participants
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
n=196 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 1 Mth post dose 3
|
136 Participants
|
130 Participants
|
142 Participants
|
133 Participants
|
—
|
|
Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 5 Mth post dose 3
|
128 Participants
|
130 Participants
|
145 Participants
|
142 Participants
|
—
|
|
Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 8 Mth post dose 3
|
139 Participants
|
128 Participants
|
136 Participants
|
135 Participants
|
—
|
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=197 Participants
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
n=197 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 1 Mth post-dose 2
|
136 Participants
|
141 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 5 Mth post-dose 2
|
136 Participants
|
155 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 3 Mth post-dose 3
|
144 Participants
|
131 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=193 Participants
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
n=194 Participants
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.
|
Synflorix 3+0d Group
n=196 Participants
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
n=196 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 1 Mth post dose 3
|
17 Participants
|
21 Participants
|
16 Participants
|
19 Participants
|
—
|
|
Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 5 Mth post dose 3
|
24 Participants
|
23 Participants
|
25 Participants
|
24 Participants
|
—
|
|
Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
At 8 Mth post dose 3
|
9 Participants
|
10 Participants
|
10 Participants
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Outcome measures
| Measure |
10PP-HD 1d Group
n=197 Participants
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
n=197 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 1 Mth post-dose 2
|
12 Participants
|
12 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 5 Mth post-dose 2
|
20 Participants
|
25 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
At 3 Mth post-dose 3
|
9 Participants
|
8 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) or at Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)Population: The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.
Isolates from the Prev13\_3D group were not selected. Samples were distributed evenly in the 5 groups and across time points: 10 isolates from pre-vaccination, 20 at Month 3, 20 at Month 7 and 20 at Month 10. Only samples displaying non-vaccine and non-vaccine related serotypes (all serotypes except serotypes 1, 4, 5 and 14 and serotypes belonging to the serogroups 6, 7, 9, 18, 19 and 23) were selected in systematic (equal number across groups) but non-random manner. Samples were described as follows: samples with gene detected (Positive isolates) with sequenced protein, number of protein Variants, number of isolates with Variant 1 (100% identity with vaccine sequence).
Outcome measures
| Measure |
10PP-HD 1d Group
n=350 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the Ply Gene - Cohort 2
Positive isolates
|
347 Samples
|
—
|
—
|
—
|
—
|
|
Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the Ply Gene - Cohort 2
Protein sequenced
|
347 Samples
|
—
|
—
|
—
|
—
|
|
Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the Ply Gene - Cohort 2
Protein variants
|
18 Samples
|
—
|
—
|
—
|
—
|
|
Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the Ply Gene - Cohort 2
Samples with Variant 1
|
216 Samples
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) or at Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)Population: The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.
Isolates from the Prev13\_3D group were not selected. Samples were distributed evenly in the 5 groups and across time points: 10 isolates from pre-vaccination, 20 at Month 3, 20 at Month 7 and 20 at Month 10. Only samples displaying non-vaccine and non-vaccine related serotypes (all serotypes except serotypes 1, 4, 5 and 14 and serotypes belonging to the serogroups 6, 7, 9, 18, 19 and 23) were selected in systematic (equal number across groups) but non-random manner. Samples were described as follows: samples with gene detected (Positive isolates) with sequenced protein, number of protein Variants, number of isolates with Variant 1 (100% identity with vaccine sequence).
Outcome measures
| Measure |
10PP-HD 1d Group
n=350 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the PhtD Gene - Cohort 2
Positive isolates
|
342 Samples
|
—
|
—
|
—
|
—
|
|
Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the PhtD Gene - Cohort 2
Protein sequenced
|
321 Samples
|
—
|
—
|
—
|
—
|
|
Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the PhtD Gene - Cohort 2
Protein variants
|
84 Samples
|
—
|
—
|
—
|
—
|
|
Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the PhtD Gene - Cohort 2
Samples with Variant 1
|
1 Samples
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)Population: The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.
Overall, 18 different Ply protein sequences were identified: 5 protein variants previously described (e.g. variants 1, 2, 7, 11 and 15), plus 13 new protein variants which are referred to as variants GSK21 to GSK33. The number of Amino Acids (AA) mutation versus vaccine sequence has been specified for each Ply variant. The samples without gene detected were considered as negative for Ply (Ply negative).
Outcome measures
| Measure |
10PP-HD 1d Group
n=20 Participants
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
n=20 Participants
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.
|
Synflorix 3+0d Group
n=20 Participants
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
n=20 Participants
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.
|
Synflorix 2+1d Group
n=20 Participants
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.
|
|---|---|---|---|---|---|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant 15 - AA = 1 at Month 7
|
2 Samples
|
0 Samples
|
1 Samples
|
1 Samples
|
1 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant 1 - AA = 0 at Month 0
|
5 Samples
|
8 Samples
|
7 Samples
|
4 Samples
|
8 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant 2 - AA = 1 at Month 0
|
4 Samples
|
0 Samples
|
1 Samples
|
4 Samples
|
1 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant 15 - AA = 1 at Month 0
|
1 Samples
|
0 Samples
|
0 Samples
|
2 Samples
|
0 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant GSK 24 - AA = 1 at Month 0
|
0 Samples
|
0 Samples
|
1 Samples
|
0 Samples
|
0 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant GSK 28 - AA = 1 at Month 0
|
0 Samples
|
0 Samples
|
1 Samples
|
0 Samples
|
0 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant GSK 33 - AA = 3 at Month 0
|
0 Samples
|
0 Samples
|
0 Samples
|
0 Samples
|
1 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant GSK 30 - AA = 4 at Month 0
|
0 Samples
|
1 Samples
|
0 Samples
|
0 Samples
|
0 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant GSK 31 - AA = 6 at Month 0
|
0 Samples
|
1 Samples
|
0 Samples
|
0 Samples
|
0 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Ply negative at Month 0
|
0 Samples
|
0 Samples
|
0 Samples
|
0 Samples
|
0 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant 1 - AA = 0 at Month 3
|
11 Samples
|
13 Samples
|
10 Samples
|
14 Samples
|
9 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant 2 - AA = 1 at Month 3
|
4 Samples
|
7 Samples
|
6 Samples
|
4 Samples
|
8 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant 15 - AA = 1 at Month 3
|
2 Samples
|
0 Samples
|
2 Samples
|
1 Samples
|
0 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant GSK 24 - AA = 1 at Month 3
|
2 Samples
|
0 Samples
|
1 Samples
|
1 Samples
|
0 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant 11 - AA = 2 at Month 3
|
0 Samples
|
0 Samples
|
0 Samples
|
0 Samples
|
1 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant GSK 23 - AA = 2 at Month 3
|
0 Samples
|
0 Samples
|
0 Samples
|
0 Samples
|
2 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Ply negative at Month 3
|
1 Samples
|
0 Samples
|
1 Samples
|
0 Samples
|
0 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant 1 - AA = 0 at Month 7
|
14 Samples
|
15 Samples
|
10 Samples
|
13 Samples
|
10 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant 2 - AA = 1 at Month 7
|
4 Samples
|
4 Samples
|
6 Samples
|
4 Samples
|
7 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant GSK 24 - AA = 1 at Month 7
|
0 Samples
|
0 Samples
|
0 Samples
|
1 Samples
|
0 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant GSK 29 - AA = 1 at Month 7
|
0 Samples
|
0 Samples
|
0 Samples
|
0 Samples
|
1 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant 7 - AA = 2 at Month 7
|
0 Samples
|
1 Samples
|
1 Samples
|
1 Samples
|
0 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant GSK 21 - AA = 2 at Month 7
|
0 Samples
|
0 Samples
|
1 Samples
|
0 Samples
|
0 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant GSK 23 - AA = 2 at Month 7
|
0 Samples
|
0 Samples
|
0 Samples
|
0 Samples
|
1 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant GSK 27 - AA = 2 at Month 7
|
0 Samples
|
0 Samples
|
1 Samples
|
0 Samples
|
0 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Ply negative at Month 7
|
0 Samples
|
0 Samples
|
0 Samples
|
0 Samples
|
0 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant 1 - AA = 0 at Month 10
|
12 Samples
|
15 Samples
|
12 Samples
|
12 Samples
|
14 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant 2 - AA = 1 at Month 10
|
5 Samples
|
2 Samples
|
6 Samples
|
5 Samples
|
4 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant 15 - AA = 1 at Month 10
|
1 Samples
|
1 Samples
|
0 Samples
|
2 Samples
|
1 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant GSK 24 - AA = 1 at Month 10
|
0 Samples
|
0 Samples
|
0 Samples
|
0 Samples
|
1 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant GSK 25 - AA = 1 at Month 10
|
0 Samples
|
1 Samples
|
0 Samples
|
0 Samples
|
0 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant 7 - AA = 2 at Month 10
|
1 Samples
|
0 Samples
|
0 Samples
|
1 Samples
|
0 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant GSK 22 - AA = 2 at Month 10
|
0 Samples
|
0 Samples
|
1 Samples
|
0 Samples
|
0 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant GSK 26 - AA = 4 at Month 10
|
0 Samples
|
0 Samples
|
1 Samples
|
0 Samples
|
0 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variant GSK 32 - AA = 7 at Month 10
|
1 Samples
|
0 Samples
|
0 Samples
|
0 Samples
|
0 Samples
|
|
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Ply negative at Month 10
|
0 Samples
|
1 Samples
|
0 Samples
|
0 Samples
|
0 Samples
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)Population: The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.
Protein sequence identity was compared to vaccine sequence. Mean and median was calculated and expressed as percentage.
Outcome measures
| Measure |
10PP-HD 1d Group
n=20 Participants
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
n=20 Participants
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.
|
Synflorix 3+0d Group
n=20 Participants
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
n=20 Participants
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.
|
Synflorix 2+1d Group
n=20 Participants
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.
|
|---|---|---|---|---|---|
|
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Median at Month 0
|
99.90 Percentage of protein identity
|
100 Percentage of protein identity
|
100 Percentage of protein identity
|
99.79 Percentage of protein identity
|
100 Percentage of protein identity
|
|
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Mean at Month 0
|
99.90 Percentage of protein identity
|
99.79 Percentage of protein identity
|
99.94 Percentage of protein identity
|
99.87 Percentage of protein identity
|
99.92 Percentage of protein identity
|
|
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Median at Month 3
|
100 Percentage of protein identity
|
100 Percentage of protein identity
|
100 Percentage of protein identity
|
100 Percentage of protein identity
|
99.79 Percentage of protein identity
|
|
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Mean at Month 3
|
99.91 Percentage of protein identity
|
99.93 Percentage of protein identity
|
99.90 Percentage of protein identity
|
99.94 Percentage of protein identity
|
99.85 Percentage of protein identity
|
|
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Median at Month 7
|
100 Percentage of protein identity
|
100 Percentage of protein identity
|
99.90 Percentage of protein identity
|
100 Percentage of protein identity
|
99.90 Percentage of protein identity
|
|
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Mean at Month 7
|
99.94 Percentage of protein identity
|
99.94 Percentage of protein identity
|
99.86 Percentage of protein identity
|
99.92 Percentage of protein identity
|
99.88 Percentage of protein identity
|
|
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Median at Month 10
|
100 Percentage of protein identity
|
100 Percentage of protein identity
|
100 Percentage of protein identity
|
100 Percentage of protein identity
|
100 Percentage of protein identity
|
|
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Mean at Month 10
|
99.84 Percentage of protein identity
|
99.95 Percentage of protein identity
|
99.87 Percentage of protein identity
|
99.91 Percentage of protein identity
|
99.94 Percentage of protein identity
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)Population: The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.
Because of high variants heterogeneity in each group (no major variant), the impact of vaccination on variant prevalence was not analysed. PhtD sequences were detected in some samples but no consensus sequence could be obtained they were defined as mixed sequences (Mix). The samples without gene detected were considered as negative for PhtD (PhtD negative).
Outcome measures
| Measure |
10PP-HD 1d Group
n=20 Participants
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
n=20 Participants
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.
|
Synflorix 3+0d Group
n=20 Participants
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
n=20 Participants
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.
|
Synflorix 2+1d Group
n=20 Participants
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.
|
|---|---|---|---|---|---|
|
Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variants number at Month 0
|
10 Samples
|
6 Samples
|
9 Samples
|
9 Samples
|
7 Samples
|
|
Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Mix number at Month 0
|
0 Samples
|
1 Samples
|
1 Samples
|
0 Samples
|
2 Samples
|
|
Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
PhtD negative at Month 0
|
0 Samples
|
2 Samples
|
0 Samples
|
1 Samples
|
1 Samples
|
|
Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variants number at Month 3
|
16 Samples
|
16 Samples
|
18 Samples
|
16 Samples
|
16 Samples
|
|
Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Mix number at Month 3
|
1 Samples
|
1 Samples
|
0 Samples
|
3 Samples
|
1 Samples
|
|
Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
PhtD negative at Month 3
|
1 Samples
|
0 Samples
|
1 Samples
|
0 Samples
|
0 Samples
|
|
Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variants number at Month 7
|
13 Samples
|
14 Samples
|
17 Samples
|
13 Samples
|
12 Samples
|
|
Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Mix number at Month 7
|
0 Samples
|
2 Samples
|
1 Samples
|
1 Samples
|
1 Samples
|
|
Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
PhtD negative at Month 7
|
0 Samples
|
0 Samples
|
0 Samples
|
0 Samples
|
0 Samples
|
|
Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Variants number at Month 10
|
13 Samples
|
12 Samples
|
13 Samples
|
15 Samples
|
11 Samples
|
|
Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Mix number at Month 10
|
1 Samples
|
0 Samples
|
1 Samples
|
1 Samples
|
3 Samples
|
|
Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
PhtD negative at Month 10
|
1 Samples
|
1 Samples
|
0 Samples
|
0 Samples
|
0 Samples
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)Population: The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.
Protein sequence identity was compared to vaccine sequence. Mean and median was calculated and expressed as percentage.
Outcome measures
| Measure |
10PP-HD 1d Group
n=20 Participants
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
n=19 Participants
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.
|
Synflorix 3+0d Group
n=19 Participants
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
n=19 Participants
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.
|
Synflorix 2+1d Group
n=19 Participants
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.
|
|---|---|---|---|---|---|
|
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Median at Month 0
|
96.3 Percentage of protein identity
|
96.7 Percentage of protein identity
|
95.8 Percentage of protein identity
|
96.7 Percentage of protein identity
|
95.7 Percentage of protein identity
|
|
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Mean at Month 0
|
95.2 Percentage of protein identity
|
97.0 Percentage of protein identity
|
96.7 Percentage of protein identity
|
96.3 Percentage of protein identity
|
96.3 Percentage of protein identity
|
|
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Median at Month 3
|
96.6 Percentage of protein identity
|
97.7 Percentage of protein identity
|
96.6 Percentage of protein identity
|
96.3 Percentage of protein identity
|
95.7 Percentage of protein identity
|
|
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Mean at Month 3
|
96.4 Percentage of protein identity
|
97.4 Percentage of protein identity
|
96.2 Percentage of protein identity
|
94.6 Percentage of protein identity
|
93.1 Percentage of protein identity
|
|
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Median at Month 7
|
97.6 Percentage of protein identity
|
96.2 Percentage of protein identity
|
97.4 Percentage of protein identity
|
97.6 Percentage of protein identity
|
95.7 Percentage of protein identity
|
|
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Mean at Month 7
|
96.7 Percentage of protein identity
|
95.6 Percentage of protein identity
|
95.7 Percentage of protein identity
|
96.7 Percentage of protein identity
|
94.7 Percentage of protein identity
|
|
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Median at Month 10
|
97.2 Percentage of protein identity
|
97.6 Percentage of protein identity
|
96.8 Percentage of protein identity
|
96.9 Percentage of protein identity
|
97.6 Percentage of protein identity
|
|
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Mean at Month 10
|
95.5 Percentage of protein identity
|
97.3 Percentage of protein identity
|
94.1 Percentage of protein identity
|
95.4 Percentage of protein identity
|
94.9 Percentage of protein identity
|
Adverse Events
10PP-HD 1d Group
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Prevnar 13 1d Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
10PP-LD 3+0d Group
Serious events: 1 serious events
Other events: 186 other events
Deaths: 0 deaths
10PP-HD 3+0d Group
Serious events: 4 serious events
Other events: 191 other events
Deaths: 1 deaths
Synflorix 3+0d Group
Serious events: 3 serious events
Other events: 193 other events
Deaths: 0 deaths
Prevnar 13 3+0d Group
Serious events: 2 serious events
Other events: 188 other events
Deaths: 2 deaths
10PP-HD 2+1d Group
Serious events: 4 serious events
Other events: 189 other events
Deaths: 2 deaths
Synflorix 2+1d Group
Serious events: 5 serious events
Other events: 184 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
10PP-HD 1d Group
n=60 participants at risk
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.
|
Prevnar 13 1d Group
n=60 participants at risk
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
n=200 participants at risk
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
n=200 participants at risk
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
n=200 participants at risk
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.
|
Prevnar 13 3+0d Group
n=200 participants at risk
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
n=200 participants at risk
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
n=200 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.50%
1/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
1.0%
2/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.50%
1/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
1.0%
2/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.50%
1/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.50%
1/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.50%
1/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
|
Infections and infestations
Sepsis
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.50%
1/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.50%
1/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.50%
1/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.50%
1/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.50%
1/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.50%
1/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.50%
1/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
|
Infections and infestations
Malaria
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.50%
1/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.50%
1/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.50%
1/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
|
General disorders
Sudden infant death syndrome
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.50%
1/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
0.00%
0/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
Other adverse events
| Measure |
10PP-HD 1d Group
n=60 participants at risk
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.
|
Prevnar 13 1d Group
n=60 participants at risk
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
n=200 participants at risk
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
n=200 participants at risk
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
n=200 participants at risk
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.
|
Prevnar 13 3+0d Group
n=200 participants at risk
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
n=200 participants at risk
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
n=200 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Pain
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
11.0%
21/191 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
13.3%
26/195 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
|
General disorders
Swelling
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
17.5%
35/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
15.5%
31/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
|
General disorders
Fever (axillary temperature ≥ 37.5°C)
|
6.7%
4/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
3.3%
2/60 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
|
Nervous system disorders
Somnolence
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
6.3%
12/191 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
2.1%
4/195 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
|
Psychiatric disorders
Irritability
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
14.1%
27/191 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
9.7%
19/195 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
12.0%
24/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
12.5%
25/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
|
General disorders
Pyrexia
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
16.8%
32/191 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
13.8%
27/195 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
|
Infections and infestations
Respiratory tract infection
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
28.0%
56/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
29.0%
58/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
|
Infections and infestations
Conjunctivitis
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
3.0%
6/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
2.0%
4/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
5.0%
10/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
3.0%
6/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
|
Infections and infestations
Upper respiratory tract infection
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
6.0%
12/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
7.0%
14/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
6.0%
12/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
5.0%
10/200 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
—
0/0 • Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER