Trial Outcomes & Findings for Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants (NCT NCT00871338)
NCT ID: NCT00871338
Last Updated: 2018-06-06
Results Overview
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
284 participants
Primary outcome timeframe
At Month 3
Results posted on
2018-06-06
Participant Flow
A total of 284 subjects were enrolled in the study.
Participant milestones
| Measure |
GSK2197870A Group
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar vaccine at Months 0 and 2 and a booster dose of Menitorix vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix vaccines were administered in the right upper anterolateral thigh and Prevenar vaccine in the left upper anterolateral thigh.
|
Pediacel Group
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel vaccine at Months 0, 1 and 2, 2 doses of Prevenar vaccine at Months 0 and 2, 2 doses of Menjugate vaccine at Months 1 and 2 and a booster dose of Menitorix at Month 10. All vaccines were administered intramuscularly. Pediacel and Menitorix vaccines were administered in the right upper anterolateral thigh and Prevenar vaccine in the left upper anterolateral thigh and Menjugate vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Prior to Booster
STARTED
|
142
|
142
|
|
Prior to Booster
COMPLETED
|
140
|
139
|
|
Prior to Booster
NOT COMPLETED
|
2
|
3
|
|
After Booster
STARTED
|
139
|
135
|
|
After Booster
COMPLETED
|
139
|
135
|
|
After Booster
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
GSK2197870A Group
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar vaccine at Months 0 and 2 and a booster dose of Menitorix vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix vaccines were administered in the right upper anterolateral thigh and Prevenar vaccine in the left upper anterolateral thigh.
|
Pediacel Group
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel vaccine at Months 0, 1 and 2, 2 doses of Prevenar vaccine at Months 0 and 2, 2 doses of Menjugate vaccine at Months 1 and 2 and a booster dose of Menitorix at Month 10. All vaccines were administered intramuscularly. Pediacel and Menitorix vaccines were administered in the right upper anterolateral thigh and Prevenar vaccine in the left upper anterolateral thigh and Menjugate vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Prior to Booster
Withdrawal by Subject
|
1
|
3
|
|
Prior to Booster
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Baseline characteristics for primary vaccine population.
Baseline characteristics by cohort
| Measure |
GSK2197870A Group
n=142 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar vaccine at Months 0 and 2 and a booster dose of Menitorix vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix vaccines were administered in the right upper anterolateral thigh and Prevenar vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=142 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel vaccine at Months 0, 1 and 2, 2 doses of Prevenar vaccine at Months 0 and 2, 2 doses of Menjugate vaccine at Months 1 and 2 and a booster dose of Menitorix at Month 10. All vaccines were administered intramuscularly. Pediacel and Menitorix vaccines were administered in the right upper anterolateral thigh and Prevenar vaccine in the left upper anterolateral thigh and Menjugate vaccine in the left lower anterolateral thigh.
|
Total
n=284 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.8 weeks
STANDARD_DEVIATION 0.39 • n=139 Participants • Baseline characteristics for booster vaccine population.
|
11.9 weeks
STANDARD_DEVIATION 0.36 • n=135 Participants • Baseline characteristics for booster vaccine population.
|
11.85 weeks
STANDARD_DEVIATION 0.38 • n=274 Participants • Baseline characteristics for booster vaccine population.
|
|
Sex: Female, Male
Female
|
59 Participants
n=139 Participants • Baseline characteristics for booster vaccine population.
|
75 Participants
n=135 Participants • Baseline characteristics for booster vaccine population.
|
134 Participants
n=274 Participants • Baseline characteristics for booster vaccine population.
|
|
Sex: Female, Male
Male
|
80 Participants
n=139 Participants • Baseline characteristics for booster vaccine population.
|
60 Participants
n=135 Participants • Baseline characteristics for booster vaccine population.
|
140 Participants
n=274 Participants • Baseline characteristics for booster vaccine population.
|
|
Race/Ethnicity, Customized
African Heritage/African American
|
2 Participants
n=139 Participants • Baseline characteristics for booster vaccine population.
|
2 Participants
n=135 Participants • Baseline characteristics for booster vaccine population.
|
4 Participants
n=274 Participants • Baseline characteristics for booster vaccine population.
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
3 Participants
n=139 Participants • Baseline characteristics for booster vaccine population.
|
3 Participants
n=135 Participants • Baseline characteristics for booster vaccine population.
|
6 Participants
n=274 Participants • Baseline characteristics for booster vaccine population.
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
1 Participants
n=139 Participants • Baseline characteristics for booster vaccine population.
|
1 Participants
n=135 Participants • Baseline characteristics for booster vaccine population.
|
2 Participants
n=274 Participants • Baseline characteristics for booster vaccine population.
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
1 Participants
n=139 Participants • Baseline characteristics for booster vaccine population.
|
1 Participants
n=135 Participants • Baseline characteristics for booster vaccine population.
|
2 Participants
n=274 Participants • Baseline characteristics for booster vaccine population.
|
|
Race/Ethnicity, Customized
White - Caucasian/European Heritage
|
119 Participants
n=139 Participants • Baseline characteristics for booster vaccine population.
|
124 Participants
n=135 Participants • Baseline characteristics for booster vaccine population.
|
243 Participants
n=274 Participants • Baseline characteristics for booster vaccine population.
|
|
Race/Ethnicity, Customized
Other
|
13 Participants
n=139 Participants • Baseline characteristics for booster vaccine population.
|
4 Participants
n=135 Participants • Baseline characteristics for booster vaccine population.
|
17 Participants
n=274 Participants • Baseline characteristics for booster vaccine population.
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=139 Participants • Baseline characteristics for booster vaccine population.
|
0 Participants
n=135 Participants • Baseline characteristics for booster vaccine population.
|
0 Participants
n=274 Participants • Baseline characteristics for booster vaccine population.
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
0 Participants
n=139 Participants • Baseline characteristics for booster vaccine population.
|
0 Participants
n=135 Participants • Baseline characteristics for booster vaccine population.
|
0 Participants
n=274 Participants • Baseline characteristics for booster vaccine population.
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=139 Participants • Baseline characteristics for booster vaccine population.
|
0 Participants
n=135 Participants • Baseline characteristics for booster vaccine population.
|
0 Participants
n=274 Participants • Baseline characteristics for booster vaccine population.
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
0 Participants
n=139 Participants • Baseline characteristics for booster vaccine population.
|
0 Participants
n=135 Participants • Baseline characteristics for booster vaccine population.
|
0 Participants
n=274 Participants • Baseline characteristics for booster vaccine population.
|
PRIMARY outcome
Timeframe: At Month 3Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
GSK2197870A Group
n=108 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=119 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Seroprotected Subjects for Anti-polyribosylribitol Phosphate (Anti-PRP).
|
108 Participants
|
111 Participants
|
PRIMARY outcome
Timeframe: At Month 2 and Month 3.Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.
Outcome measures
| Measure |
GSK2197870A Group
n=109 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=113 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Seropositive Subjects Against Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC)
rSBA-MenC at Month 2 [N=109;111]
|
104 Participants
|
109 Participants
|
|
Number of Seropositive Subjects Against Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC)
rSBA-MenC at Month 3 [N=105;113]
|
101 Participants
|
113 Participants
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
The reference cut-off was ≥ 1.0 micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
GSK2197870A Group
n=108 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=119 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Subjects With Anti-PRP Concentrations Antibody Above the Cut-off.
|
96 Subjects
|
98 Subjects
|
SECONDARY outcome
Timeframe: At Month 2 and Month 3.Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.
Outcome measures
| Measure |
GSK2197870A Group
n=113 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=115 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs.
Anti-PSC ≥ 0.3 µg/mL at Month 2 [N=113;115]
|
113 Subjects
|
115 Subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs.
Anti-PSC ≥ 0.3 µg/mL at Month 3 [N=108;114]
|
108 Subjects
|
114 Subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs.
Anti-PSC ≥ 2.0 µg/mL at Month 2 [N=113;115]
|
113 Subjects
|
113 Subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs.
Anti-PSC ≥ 2.0 µg/mL at Month 3 [N=108;114]
|
107 Subjects
|
114 Subjects
|
SECONDARY outcome
Timeframe: At Month 3.Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Outcome measures
| Measure |
GSK2197870A Group
n=108 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=119 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Anti-D
|
108 Subjects
|
119 Subjects
|
|
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Anti-T
|
108 Subjects
|
119 Subjects
|
SECONDARY outcome
Timeframe: At Month 3.Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
Outcome measures
| Measure |
GSK2197870A Group
n=108 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=120 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN).
Anti-PT [N=107;117]
|
107 Subjects
|
117 Subjects
|
|
Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN).
Anti-FHA [N=106;119]
|
106 Subjects
|
119 Subjects
|
|
Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN).
Anti-PRN [N=108;120]
|
108 Subjects
|
119 Subjects
|
SECONDARY outcome
Timeframe: At Month 3.Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.
Outcome measures
| Measure |
GSK2197870A Group
n=89 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=94 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
Anti-polio 1
|
89 Subjects
|
93 Subjects
|
|
Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
Anti-polio 2
|
88 Subjects
|
92 Subjects
|
|
Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
Anti-polio 3
|
89 Subjects
|
94 Subjects
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.2 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 4, 6B, 9V, 14, 18C, 19F and 23F.
Outcome measures
| Measure |
GSK2197870A Group
n=108 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=112 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 19F [N=47;52]
|
46 Subjects
|
52 Subjects
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 23F [N=47;52]
|
37 Subjects
|
49 Subjects
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 4 [N=47;52]
|
47 Subjects
|
52 Subjects
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 6B [N=46;52]
|
14 Subjects
|
13 Subjects
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 9V [N=47;51]
|
46 Subjects
|
49 Subjects
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 14 [N=47;52]
|
47 Subjects
|
50 Subjects
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 18C [N=46;52]
|
45 Subjects
|
51 Subjects
|
SECONDARY outcome
Timeframe: At Month 3.Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL.
Outcome measures
| Measure |
GSK2197870A Group
n=108 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=119 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Concentrations for Anti-PRP.
|
4.347 µg/mL
Interval 3.507 to 5.389
|
4.347 µg/mL
Interval 3.507 to 5.389
|
SECONDARY outcome
Timeframe: At Month 2 and Month 3.Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off value was ≥ 1:8.
Outcome measures
| Measure |
GSK2197870A Group
n=109 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=113 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Titers for rSBA-MenC.
rSBA-MenC at Month 2 [N=109;111]
|
339.4 titers
Interval 254.5 to 452.7
|
257.0 titers
Interval 204.5 to 323.0
|
|
Titers for rSBA-MenC.
rSBA-MenC at Month 3 [N=105;113]
|
393.2 titers
Interval 292.5 to 528.7
|
3110.5 titers
Interval 2612.0 to 3704.2
|
SECONDARY outcome
Timeframe: At Month 2 and Month 3.Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL.
Outcome measures
| Measure |
GSK2197870A Group
n=113 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=115 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Concentrations for Anti-PSC.
Anti-PSC at Month 2 [N=113;115]
|
18.20 µg/mL
Interval 15.91 to 20.82
|
10.77 µg/mL
Interval 9.61 to 12.08
|
|
Concentrations for Anti-PSC.
Anti-PSC at Month 3 [N=108;114]
|
15.10 µg/mL
Interval 13.0 to 17.55
|
17.29 µg/mL
Interval 15.53 to 19.25
|
SECONDARY outcome
Timeframe: At Month 3.Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL.
Outcome measures
| Measure |
GSK2197870A Group
n=108 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=119 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Concentrations for Anti-T and Anti-D.
Anti-T
|
2.694 IU/mL
Interval 2.394 to 3.032
|
1.034 IU/mL
Interval 0.895 to 1.195
|
|
Concentrations for Anti-T and Anti-D.
Anti-D
|
1.767 IU/mL
Interval 1.548 to 2.019
|
1.817 IU/mL
Interval 1.589 to 2.078
|
SECONDARY outcome
Timeframe: At Month 3.Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity reference cut-off value was ≥ 5 EL.U/mL.
Outcome measures
| Measure |
GSK2197870A Group
n=108 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=120 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Anti-PT [N=107;117]
|
45.4 EL.U/mL
Interval 40.0 to 51.4
|
45.1 EL.U/mL
Interval 39.8 to 51.2
|
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Anti-FHA [N=106;119]
|
234.4 EL.U/mL
Interval 203.7 to 269.6
|
204.9 EL.U/mL
Interval 178.2 to 235.6
|
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Anti-PRN [N=108;120]
|
121.6 EL.U/mL
Interval 103.6 to 142.7
|
49.9 EL.U/mL
Interval 41.4 to 60.1
|
SECONDARY outcome
Timeframe: At Month 3.Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
Titers were expressed as geometric mean titers (GMTs). The seropositivity reference cut-off value was ≥ 1:8.
Outcome measures
| Measure |
GSK2197870A Group
n=89 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=94 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Titers for Anti-polio 1, 2 and 3.
Anti-polio 1
|
169.4 titers
Interval 127.0 to 226.0
|
89.3 titers
Interval 71.1 to 112.2
|
|
Titers for Anti-polio 1, 2 and 3.
Anti-polio 2
|
90.2 titers
Interval 68.5 to 118.7
|
77.7 titers
Interval 59.7 to 101.1
|
|
Titers for Anti-polio 1, 2 and 3.
Anti-polio 3
|
367.9 titers
Interval 288.1 to 469.9
|
250.5 titers
Interval 195.9 to 320.2
|
SECONDARY outcome
Timeframe: At Month 3.Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
Concentrations were expressed as geometric mean concentreations (GMCs). The seropositivity reference cut-off value was ≥ 0.2 µg/mL.
Outcome measures
| Measure |
GSK2197870A Group
n=89 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=94 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Concentrations for Anti-PNE Serotypes.
Anti- PNE 4 [N=47;52]
|
2.56 µg/mL
Interval 2.13 to 3.07
|
2.18 µg/mL
Interval 1.87 to 2.53
|
|
Concentrations for Anti-PNE Serotypes.
Anti- PNE 6B [N=46;52]
|
0.12 µg/mL
Interval 0.08 to 0.17
|
0.12 µg/mL
Interval 0.08 to 0.16
|
|
Concentrations for Anti-PNE Serotypes.
Anti- PNE 9V [N=47;51]
|
2.56 µg/mL
Interval 1.92 to 3.43
|
1.85 µg/mL
Interval 1.43 to 2.39
|
|
Concentrations for Anti-PNE Serotypes.
Anti- PNE 14 [N=47;52]
|
3.78 µg/mL
Interval 2.7 to 5.28
|
2.71 µg/mL
Interval 2.0 to 3.67
|
|
Concentrations for Anti-PNE Serotypes.
Anti- PNE 18C [N=46;52]
|
2.26 µg/mL
Interval 1.59 to 3.2
|
2.74 µg/mL
Interval 2.12 to 3.56
|
|
Concentrations for Anti-PNE Serotypes.
Anti- PNE 19F [N=47;52]
|
3.00 µg/mL
Interval 2.21 to 4.06
|
3.15 µg/mL
Interval 2.51 to 3.95
|
|
Concentrations for Anti-PNE Serotypes.
Anti- PNE 23F [N=47;52]
|
0.58 µg/mL
Interval 0.4 to 0.82
|
0.89 µg/mL
Interval 0.69 to 1.14
|
SECONDARY outcome
Timeframe: At Month 10 and Month 11.Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
GSK2197870A Group
n=98 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=112 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Seroprotected Subjects for Anti-PRP.
Anti-PRP at Month 10 [N=89;98]
|
76 Subjects
|
81 Subjects
|
|
Number of Seroprotected Subjects for Anti-PRP.
Anti-PRP at Month 11 [N=98;112]
|
98 Subjects
|
112 Subjects
|
SECONDARY outcome
Timeframe: At Month 10 and Month 11.Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.
Outcome measures
| Measure |
GSK2197870A Group
n=94 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=109 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Seropositive Subjects Against rSBA-MenC.
rSBA-MenC at Month 10 [N=87;93]
|
70 Subjects
|
78 Subjects
|
|
Number of Seropositive Subjects Against rSBA-MenC.
rSBA-MenC at Month 11 [N=94;109]
|
93 Subjects
|
109 Subjects
|
SECONDARY outcome
Timeframe: At Month 10 and Month 11.Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.
Outcome measures
| Measure |
GSK2197870A Group
n=100 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=111 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs.
Anti-PSC ≥ 0.3 µg/mL at Month 10 [N=86;97]
|
81 Subjects
|
89 Subjects
|
|
Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs.
Anti-PSC ≥ 0.3 µg/mL at Month 11 [N=100;111]
|
100 Subjects
|
111 Subjects
|
|
Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs.
Anti-PSC ≥ 2.0 µg/mL at Month 10 [N=86;97]
|
22 Subjects
|
14 Subjects
|
|
Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs.
Anti-PSC ≥ 2.0 µg/mL at Month 11 [N=100;111]
|
92 Subjects
|
80 Subjects
|
SECONDARY outcome
Timeframe: At Month 10.Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
A seropositive subject was defined as a vaccinated subject who had anti-D (ELISA) and anti-T antibody concentrations ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay).
Outcome measures
| Measure |
GSK2197870A Group
n=89 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=98 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies.
Anti-T ≥ 0.1 IU/mL [N=89;98]
|
86 Subjects
|
87 Subjects
|
|
Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies.
Anti-D ≥ 0.1 IU/mL [N=89;98]
|
72 Subjects
|
94 Subjects
|
|
Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies.
Anti-D ≥ 0.016 IU/mL [N=16;3]
|
11 Subjects
|
3 Subjects
|
SECONDARY outcome
Timeframe: At Month 10.Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
Outcome measures
| Measure |
GSK2197870A Group
n=89 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=100 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
Anti-PT [N=89;100]
|
60 Subjects
|
88 Subjects
|
|
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
Anti-FHA [N=89;99]
|
89 Subjects
|
98 Subjects
|
|
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
Anti-PRN [N=89;100]
|
75 Subjects
|
72 Subjects
|
SECONDARY outcome
Timeframe: At Month 10.Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.
Outcome measures
| Measure |
GSK2197870A Group
n=78 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=86 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3.
Anti-polio 1 [N=78;86]
|
68 Subjects
|
62 Subjects
|
|
Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3.
Anti-polio 2 [N=78;85]
|
63 Subjects
|
69 Subjects
|
|
Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3.
Anti-polio 3 [N=78;86]
|
74 Subjects
|
76 Subjects
|
SECONDARY outcome
Timeframe: At Month 10 and Month 11.Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL.
Outcome measures
| Measure |
GSK2197870A Group
n=98 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=112 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Concentrations for Anti-PRP.
Anti-PRP at Month 10 [N=89;98]
|
0.423 µg /mL
Interval 0.339 to 0.528
|
0.574 µg /mL
Interval 0.436 to 0.756
|
|
Concentrations for Anti-PRP.
Anti-PRP at Month 11 [N=98;112]
|
66.697 µg /mL
Interval 53.271 to 83.507
|
26.899 µg /mL
Interval 20.931 to 34.569
|
SECONDARY outcome
Timeframe: At Month 10 and Month 11.Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off value was ≥ 1:8.
Outcome measures
| Measure |
GSK2197870A Group
n=93 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=109 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Titers for rSBA-MenC.
rSBA-MenC at Month 10 [N=87;94]
|
62.1 titers
Interval 43.3 to 89.1
|
67.1 titers
Interval 48.5 to 92.7
|
|
Titers for rSBA-MenC.
rSBA-MenC at Month 11 [N=93;109]
|
3062.9 titers
Interval 2421.2 to 3874.6
|
954.0 titers
Interval 761.3 to 1195.5
|
SECONDARY outcome
Timeframe: At Month 10 and Month 11.Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL.
Outcome measures
| Measure |
GSK2197870A Group
n=100 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=111 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Concentrations for Anti-PSC.
Anti-PSC at Month 10 [N=86;97]
|
0.94 µg /mL
Interval 0.76 to 1.15
|
0.87 µg /mL
Interval 0.74 to 1.04
|
|
Concentrations for Anti-PSC.
Anti-PSC at Month 11 [N=100;111]
|
6.15 µg /mL
Interval 5.24 to 7.22
|
2.88 µg /mL
Interval 2.49 to 3.32
|
SECONDARY outcome
Timeframe: At Month 10.Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay).
Outcome measures
| Measure |
GSK2197870A Group
n=89 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=98 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Concentrations for Anti-T and Anti-D.
Anti-T ≥ 0.1 IU/mL [N=89;98]
|
0.428 IU/mL
Interval 0.361 to 0.508
|
0.260 IU/mL
Interval 0.217 to 0.311
|
|
Concentrations for Anti-T and Anti-D.
Anti-D ≥ 0.1 IU/mL [N=89;98]
|
0.249 IU/mL
Interval 0.202 to 0.307
|
0.385 IU/mL
Interval 0.33 to 0.448
|
|
Concentrations for Anti-T and Anti-D.
Anti-D ≥ 0.016 IU/mL [N=16;3]
|
0.015 IU/mL
Interval 0.012 to 0.02
|
0.020 IU/mL
Interval 0.008 to 0.052
|
SECONDARY outcome
Timeframe: At Month 10.Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity reference cut-off value was ≥ 5 EL.U/mL.
Outcome measures
| Measure |
GSK2197870A Group
n=89 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=100 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Anti-PT [N=89;100]
|
7.3 EL.U/mL
Interval 6.1 to 8.8
|
9.8 EL.U/mL
Interval 8.5 to 11.4
|
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Anti-FHA [N=89;99]
|
35.3 EL.U/mL
Interval 28.3 to 44.0
|
48.8 EL.U/mL
Interval 40.4 to 58.9
|
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Anti-PRN [N=89;100]
|
15.0 EL.U/mL
Interval 11.8 to 19.0
|
9.6 EL.U/mL
Interval 7.7 to 11.9
|
SECONDARY outcome
Timeframe: At Month 10.Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
Titers were expressed as geometric mean titers (GMTs). The seroprotection reference cut-off value was ≥ 1:8.
Outcome measures
| Measure |
GSK2197870A Group
n=78 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=89 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Titers for Anti-polio 1, 2 and 3.
Anti-polio 1 [N=78;86]
|
36.3 titers
Interval 26.5 to 49.8
|
18.8 titers
Interval 14.4 to 24.7
|
|
Titers for Anti-polio 1, 2 and 3.
Anti-polio 2 [N=78;85]
|
28.5 titers
Interval 20.9 to 39.0
|
24.5 titers
Interval 18.8 to 32.0
|
|
Titers for Anti-polio 1, 2 and 3.
Anti-polio 3 [N=78;86]
|
70.1 titers
Interval 51.0 to 96.3
|
50.7 titers
Interval 37.0 to 69.4
|
SECONDARY outcome
Timeframe: At Month 11Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
Booster response defined as: for initially seronegative subjects, antibody titre ≥ 1:32 at post-booster (Month 11); for initially seropositive subjects, antibody titres at post-booster ≥ 4 fold the pre-booster.
Outcome measures
| Measure |
GSK2197870A Group
n=71 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=79 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Subjects With a Booster Response to rSBA-MenC Antibodies.
|
68 Subjects
|
61 Subjects
|
SECONDARY outcome
Timeframe: At Month 11Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 0.6 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster.
Outcome measures
| Measure |
GSK2197870A Group
n=75 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=87 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Subjects With a Booster Response to Anti-PRP Antibodies.
|
75 Subjects
|
85 Subjects
|
SECONDARY outcome
Timeframe: At Month 11Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 1.2 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster.
Outcome measures
| Measure |
GSK2197870A Group
n=75 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=83 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Subjects With a Booster Response to Anti-PSC Antibodies.
|
48 Subjects
|
27 Subjects
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7)Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Outcome measures
| Measure |
GSK2197870A Group
n=142 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=141 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Subjects Reporting Any Solicited Local Symptoms.
Any pain
|
57 Subjects
|
57 Subjects
|
|
Number of Subjects Reporting Any Solicited Local Symptoms.
Any redness
|
86 Subjects
|
77 Subjects
|
|
Number of Subjects Reporting Any Solicited Local Symptoms.
Any swelling
|
60 Subjects
|
48 Subjects
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7)Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Outcome measures
| Measure |
GSK2197870A Group
n=136 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=134 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Subjects Reporting Any Solicited Local Symptoms.
Any pain
|
24 Subjects
|
11 Subjects
|
|
Number of Subjects Reporting Any Solicited Local Symptoms.
Any redness
|
74 Subjects
|
56 Subjects
|
|
Number of Subjects Reporting Any Solicited Local Symptoms.
Any swelling
|
35 Subjects
|
20 Subjects
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7)Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course.
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever \[axillary temperature above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of any local symptom regardless of intensity grade.
Outcome measures
| Measure |
GSK2197870A Group
n=142 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=141 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Subjects Reporting Any Solicited General Symptoms.
Any drowsiness
|
103 Subjects
|
103 Subjects
|
|
Number of Subjects Reporting Any Solicited General Symptoms.
Any irritability
|
122 Subjects
|
117 Subjects
|
|
Number of Subjects Reporting Any Solicited General Symptoms.
Any loss of appetite
|
79 Subjects
|
77 Subjects
|
|
Number of Subjects Reporting Any Solicited General Symptoms.
Any fever
|
59 Subjects
|
49 Subjects
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7)Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose.
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever \[axillary temperature above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of any local symptom regardless of intensity grade.
Outcome measures
| Measure |
GSK2197870A Group
n=136 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=134 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Subjects Reporting Any Solicited General Symptoms.
Any drowsiness
|
43 Subjects
|
40 Subjects
|
|
Number of Subjects Reporting Any Solicited General Symptoms.
Any irritability
|
75 Subjects
|
66 Subjects
|
|
Number of Subjects Reporting Any Solicited General Symptoms.
Any loss of appetite
|
41 Subjects
|
40 Subjects
|
|
Number of Subjects Reporting Any Solicited General Symptoms.
Any fever
|
18 Subjects
|
20 Subjects
|
SECONDARY outcome
Timeframe: Within the 31-day (Days 0-30) follow up period after vaccination.Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course.
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
Outcome measures
| Measure |
GSK2197870A Group
n=142 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=142 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
|
114 Subjects
|
112 Subjects
|
SECONDARY outcome
Timeframe: Within the 31-day (Days 0-30) follow up period after vaccination.Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose.
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
Outcome measures
| Measure |
GSK2197870A Group
n=139 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=135 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
|
75 Subjects
|
66 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Month 0 to Month 11)Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
Outcome measures
| Measure |
GSK2197870A Group
n=142 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=142 Participants
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
|
9 Subjects
|
6 Subjects
|
Adverse Events
GSK2197870A Group
Serious events: 9 serious events
Other events: 141 other events
Deaths: 0 deaths
Pediacel Group
Serious events: 6 serious events
Other events: 141 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK2197870A Group
n=142 participants at risk
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar vaccine at Months 0 and 2 and a booster dose of Menitorix vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix vaccines were administered in the right upper anterolateral thigh and Prevenar vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=142 participants at risk
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel vaccine at Months 0, 1 and 2, 2 doses of Prevenar vaccine at Months 0 and 2, 2 doses of Menjugate vaccine at Months 1 and 2 and a booster dose of Menitorix at Month 10. All vaccines were administered intramuscularly. Pediacel and Menitorix vaccines were administered in the right upper anterolateral thigh and Prevenar vaccine in the left upper anterolateral thigh and Menjugate vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Infections and infestations
Bronchiolitis
|
0.70%
1/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
1.4%
2/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
0.70%
1/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
Infections and infestations
Viral infection
|
1.4%
2/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
0.00%
0/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.70%
1/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
0.00%
0/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.70%
1/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
0.00%
0/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
Nervous system disorders
Cerebral atrophy
|
0.00%
0/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
0.70%
1/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
0.70%
1/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
General disorders
Developmental delay
|
0.70%
1/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
0.00%
0/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
0.70%
1/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
Vascular disorders
Hypertension
|
0.70%
1/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
0.00%
0/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
Gastrointestinal disorders
Intussusception
|
0.70%
1/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
0.00%
0/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.70%
1/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
0.00%
0/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
Blood and lymphatic system disorders
Lymph node abscess
|
0.00%
0/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
0.70%
1/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.70%
1/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
0.00%
0/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
Other adverse events
| Measure |
GSK2197870A Group
n=142 participants at risk
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar vaccine at Months 0 and 2 and a booster dose of Menitorix vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix vaccines were administered in the right upper anterolateral thigh and Prevenar vaccine in the left upper anterolateral thigh.
|
Pediacel Group
n=142 participants at risk
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel vaccine at Months 0, 1 and 2, 2 doses of Prevenar vaccine at Months 0 and 2, 2 doses of Menjugate vaccine at Months 1 and 2 and a booster dose of Menitorix at Month 10. All vaccines were administered intramuscularly. Pediacel and Menitorix vaccines were administered in the right upper anterolateral thigh and Prevenar vaccine in the left upper anterolateral thigh and Menjugate vaccine in the left lower anterolateral thigh.
|
|---|---|---|
|
Infections and infestations
Rhinitis
|
29.6%
42/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
24.6%
35/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
Gastrointestinal disorders
Teething
|
20.1%
28/139 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
16.2%
23/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
5/139 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
4.9%
7/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
Gastrointestinal disorders
Vomiting
|
14.8%
21/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
9.9%
14/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
11/139 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
1.4%
2/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.9%
7/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
10.6%
15/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.9%
7/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
9.9%
14/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
5/139 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
4.9%
7/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
General disorders
Rash
|
5.0%
7/139 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
6.3%
9/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
General disorders
Pain
|
16.9%
24/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
8.2%
11/134 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
General disorders
Redness
|
53.5%
76/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
41.8%
56/134 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
General disorders
Swelling
|
24.6%
35/142 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
14.9%
20/134 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
General disorders
Drowsiness
|
31.6%
43/136 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
29.9%
40/134 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
General disorders
Irritability
|
55.1%
75/136 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
49.3%
66/134 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
General disorders
Loss of appetite
|
30.1%
41/136 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
29.9%
40/134 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
|
General disorders
Fever
|
13.2%
18/136 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
14.9%
20/134 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
|
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