Trial Outcomes & Findings for Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age (NCT NCT00970307)
NCT ID: NCT00970307
Last Updated: 2020-01-03
Results Overview
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
421 participants
Primary outcome timeframe
At Month 3
Results posted on
2020-01-03
Participant Flow
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participant milestones
| Measure |
GSK2202083A + Synflorix Group
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Overall Study
STARTED
|
141
|
139
|
141
|
|
Overall Study
COMPLETED
|
138
|
136
|
139
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
2
|
Reasons for withdrawal
| Measure |
GSK2202083A + Synflorix Group
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Overall Study
Serious Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
2
|
Baseline Characteristics
Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
Baseline characteristics by cohort
| Measure |
GSK2202083A + Synflorix Group
n=141 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=139 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=141 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Total
n=421 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
8.5 Weeks
STANDARD_DEVIATION 0.98 • n=99 Participants
|
8.7 Weeks
STANDARD_DEVIATION 1.02 • n=107 Participants
|
8.7 Weeks
STANDARD_DEVIATION 1.13 • n=206 Participants
|
8.63 Weeks
STANDARD_DEVIATION 1.05 • n=7 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
228 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
193 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White-Caucasian/European heritage
|
141 Participants
n=99 Participants
|
139 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
421 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=126 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=132 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=131 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)
|
126 Participants
|
123 Participants
|
130 Participants
|
PRIMARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
A seroprotected subject was defined as a subject with rSBA-MenC titers greater than or equal to (≥) 1:8.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=126 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=130 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=128 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Complement (rSBA-MenC)
|
124 Participants
|
127 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: At Months 0 and 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.15 µg/mL.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=126 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=132 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=131 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Anti-PRP Antibody Concentrations
Anti-PRP, Month 0
|
0.197 µg/mL
Interval 0.162 to 0.24
|
0.152 µg/mL
Interval 0.125 to 0.184
|
0.176 µg/mL
Interval 0.143 to 0.217
|
|
Anti-PRP Antibody Concentrations
Anti-PRP, Month 3
|
4.255 µg/mL
Interval 3.591 to 5.043
|
1.123 µg/mL
Interval 0.89 to 1.416
|
1.721 µg/mL
Interval 1.383 to 2.143
|
SECONDARY outcome
Timeframe: At Months 0 and 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
The seroprotection cut-off value of the assay was an antibody titer ≥ 1:8.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=126 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=130 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=128 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Antibody Titers Against rSBA-MenC
rSBA-MenC, Month 0
|
4.3 Titers
Interval 4.0 to 4.7
|
4.8 Titers
Interval 4.2 to 5.5
|
4.2 Titers
Interval 4.0 to 4.5
|
|
Antibody Titers Against rSBA-MenC
rSBA-MenC, Month 3
|
786.9 Titers
Interval 637.2 to 971.9
|
2674 Titers
Interval 2125.1 to 3364.7
|
6.1 Titers
Interval 4.7 to 8.0
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
A seropositive subject was defined as a subject with anti-PSC antibody concentration ≥ 0.3 µg/mL.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=125 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=126 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=132 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Number of Seropositive Subjects for Anti-polysaccharide Neisseria Meningitidis Serogroup C (Anti-PSC)
|
124 Participants
|
125 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: At Months 0 and 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 µg/mL.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=125 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=126 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=132 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Anti-PSC Antibody Concentrations
Anti-PSC, Month 0
|
0.17 µg/mL
Interval 0.16 to 0.19
|
0.17 µg/mL
Interval 0.16 to 0.19
|
0.18 µg/mL
Interval 0.16 to 0.2
|
|
Anti-PSC Antibody Concentrations
Anti-PSC, Month 3
|
19.15 µg/mL
Interval 16.88 to 21.74
|
18.1 µg/mL
Interval 15.91 to 20.59
|
0.19 µg/mL
Interval 0.16 to 0.22
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
A seroprotected subject was defined as a subject with anti-D or anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=126 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=132 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=132 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T)
Anti-D
|
126 Participants
|
132 Participants
|
132 Participants
|
|
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T)
Anti-T
|
126 Participants
|
132 Participants
|
132 Participants
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.1 IU/mL.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=126 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=132 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=132 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Anti-D and Anti-T Antibody Concentrations
Anti-D
|
1.671 IU/mL
Interval 1.471 to 1.899
|
1.437 IU/mL
Interval 1.286 to 1.606
|
1.421 IU/mL
Interval 1.27 to 1.591
|
|
Anti-D and Anti-T Antibody Concentrations
Anti-T
|
3.966 IU/mL
Interval 3.65 to 4.309
|
1.595 IU/mL
Interval 1.422 to 1.79
|
2.458 IU/mL
Interval 2.198 to 2.75
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
A seropositive subject was defined as a subject with anti-PT, anti-FHA or anti-PRN concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=127 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=132 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=132 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Anti-PT
|
127 Participants
|
132 Participants
|
132 Participants
|
|
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Anti-FHA
|
127 Participants
|
131 Participants
|
132 Participants
|
|
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Anti-PRN
|
126 Participants
|
132 Participants
|
131 Participants
|
SECONDARY outcome
Timeframe: At Months 0 and 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=127 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=132 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=132 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PT, Month 0
|
3.5 EL.U/mL
Interval 3.1 to 4.0
|
3.6 EL.U/mL
Interval 3.1 to 4.0
|
3.8 EL.U/mL
Interval 3.3 to 4.4
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PT, Month 3
|
36.1 EL.U/mL
Interval 32.8 to 39.8
|
41.7 EL.U/mL
Interval 37.4 to 46.4
|
37.6 EL.U/mL
Interval 34.2 to 41.4
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-FHA, Month 0
|
12.9 EL.U/mL
Interval 10.7 to 15.6
|
11.9 EL.U/mL
Interval 9.5 to 14.9
|
13.2 EL.U/mL
Interval 10.6 to 16.5
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-FHA, Month 3
|
110.9 EL.U/mL
Interval 98.1 to 125.4
|
136.4 EL.U/mL
Interval 121.3 to 153.5
|
112.7 EL.U/mL
Interval 100.9 to 126.0
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PRN, Month 0
|
5.3 EL.U/mL
Interval 4.4 to 6.4
|
4.3 EL.U/mL
Interval 3.7 to 5.1
|
5.4 EL.U/mL
Interval 4.5 to 6.5
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PRN, Month 3
|
70.3 EL.U/mL
Interval 59.6 to 82.8
|
107.4 EL.U/mL
Interval 93.0 to 124.2
|
90.4 EL.U/mL
Interval 78.1 to 104.6
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
A subject with a vaccine response was defined as either an initially seronegative subject with anti-PT, anti-FHA or anti-PRN concentrations ≥ 5 EL.U/mL or an initially seropositive subjects with antibody concentrations one month after the primary vaccination ≥ 1 fold the-pre vaccination antibody concentration.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=126 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=131 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=131 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN
Anti-PT
|
121 Participants
|
124 Participants
|
122 Participants
|
|
Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN
Anti-FHA
|
116 Participants
|
123 Participants
|
120 Participants
|
|
Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN
Anti-PRN
|
112 Participants
|
123 Participants
|
123 Participants
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. A seropositive subject was defined as a subjects with anti-HBs antibody concentrations ≥ 3.3 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=116 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=124 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=122 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs)
Anti-HBs ≥ 10 mIU/mL
|
116 Participants
|
124 Participants
|
122 Participants
|
|
Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs)
Anti-HBs ≥ 3.3 mIU/mL
|
116 Participants
|
124 Participants
|
122 Participants
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
Antibody concentrations were expressed as GMCs. The seroprotection cut-off used was of ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the CLIA approved by the FDA. The table shows updated results following partial or complete retesting/reanalysis.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=116 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=124 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=122 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Anti-HBs Antibody Concentrations
|
1001.4 mIU/mL
Interval 826.1 to 1213.9
|
1187.7 mIU/mL
Interval 997.8 to 1413.7
|
1073.2 mIU/mL
Interval 886.3 to 1299.5
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
A seroprotected subject was defined as a subject with anti-polio type 1, 2 or 3 antibody titers ≥ 1:8.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=91 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=103 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=92 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3
Anti-polio type 3
|
90 Participants
|
102 Participants
|
91 Participants
|
|
Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3
Anti-polio type 1
|
91 Participants
|
103 Participants
|
92 Participants
|
|
Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3
Anti-polio type 2
|
90 Participants
|
101 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
Titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=91 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=103 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=92 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Anti-polio Types 1, 2 and 3 Antibody Titers
Anti-polio type 1
|
132.3 Titers
Interval 104.7 to 167.3
|
156.7 Titers
Interval 127.2 to 193.0
|
126.2 Titers
Interval 98.9 to 161.0
|
|
Anti-polio Types 1, 2 and 3 Antibody Titers
Anti-polio type 2
|
97.4 Titers
Interval 74.0 to 128.1
|
104.3 Titers
Interval 80.8 to 134.7
|
95.8 Titers
Interval 74.4 to 123.3
|
|
Anti-polio Types 1, 2 and 3 Antibody Titers
Anti-polio type 3
|
275.6 Titers
Interval 218.2 to 348.1
|
313.1 Titers
Interval 250.7 to 391.0
|
257.1 Titers
Interval 203.8 to 324.3
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
A seropositive subject was defined as a subject with anti-pneumo concentrations ≥ 0.05 µg/mL. The anti-pneumo serotypes assessed were: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=127 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=127 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=129 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes
Anti-pneumo 1
|
125 Participants
|
37 Participants
|
124 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes
Anti-pneumo 4
|
122 Participants
|
21 Participants
|
127 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes
Anti-pneumo 5
|
126 Participants
|
44 Participants
|
126 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes
Anti-pneumo 6B
|
114 Participants
|
28 Participants
|
117 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes
Anti-pneumo 7F
|
125 Participants
|
56 Participants
|
128 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes
Anti-pneumo 9V
|
126 Participants
|
37 Participants
|
126 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes
Anti-pneumo 14
|
126 Participants
|
106 Participants
|
128 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes
Anti-pneumo 18C
|
122 Participants
|
52 Participants
|
126 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes
Anti-pneumo 19F
|
127 Participants
|
88 Participants
|
127 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes
Anti-pneumo 23F
|
123 Participants
|
34 Participants
|
124 Participants
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.05 µg/mL.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=127 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=127 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=129 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Anti-pneumo Antibody Concentrations
Anti-pneumo 1
|
1.53 µg/mL
Interval 1.36 to 1.72
|
0.04 µg/mL
Interval 0.04 to 0.05
|
1.41 µg/mL
Interval 1.2 to 1.65
|
|
Anti-pneumo Antibody Concentrations
Anti-pneumo 4
|
1.92 µg/mL
Interval 1.66 to 2.22
|
0.04 µg/mL
Interval 0.03 to 0.04
|
1.99 µg/mL
Interval 1.69 to 2.33
|
|
Anti-pneumo Antibody Concentrations
Anti-pneumo 5
|
2.23 µg/mL
Interval 1.99 to 2.5
|
0.05 µg/mL
Interval 0.04 to 0.06
|
2.23 µg/mL
Interval 1.9 to 2.61
|
|
Anti-pneumo Antibody Concentrations
Anti-pneumo 6B
|
0.4 µg/mL
Interval 0.32 to 0.49
|
0.04 µg/mL
Interval 0.03 to 0.04
|
0.44 µg/mL
Interval 0.35 to 0.55
|
|
Anti-pneumo Antibody Concentrations
Anti-pneumo 7F
|
2.26 µg/mL
Interval 2.02 to 2.53
|
0.06 µg/mL
Interval 0.05 to 0.07
|
2.24 µg/mL
Interval 1.95 to 2.56
|
|
Anti-pneumo Antibody Concentrations
Anti-pneumo 9V
|
2.16 µg/mL
Interval 1.9 to 2.46
|
0.05 µg/mL
Interval 0.04 to 0.06
|
1.99 µg/mL
Interval 1.72 to 2.3
|
|
Anti-pneumo Antibody Concentrations
Anti-pneumo 14
|
3.75 µg/mL
Interval 3.23 to 4.36
|
0.22 µg/mL
Interval 0.17 to 0.28
|
3.75 µg/mL
Interval 3.26 to 4.32
|
|
Anti-pneumo Antibody Concentrations
Anti-pneumo 18C
|
3.83 µg/mL
Interval 3.22 to 4.56
|
0.05 µg/mL
Interval 0.04 to 0.07
|
2.51 µg/mL
Interval 2.11 to 2.99
|
|
Anti-pneumo Antibody Concentrations
Anti-pneumo 19F
|
3.99 µg/mL
Interval 3.37 to 4.72
|
0.1 µg/mL
Interval 0.08 to 0.13
|
3.86 µg/mL
Interval 3.19 to 4.66
|
|
Anti-pneumo Antibody Concentrations
Anti-pneumo 23F
|
0.68 µg/mL
Interval 0.55 to 0.84
|
0.04 µg/mL
Interval 0.03 to 0.05
|
0.63 µg/mL
Interval 0.5 to 0.79
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
A seropositive subject was defined as a subject with anti-PD concentrations ≥ 100 EL.U/mL.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=126 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=129 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=131 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Number of Seropositive Subjects for Anti-protein D (Anti-PD)
|
126 Participants
|
18 Participants
|
130 Participants
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 100 EL.U/mL.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=126 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=129 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=131 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Anti-PD Antibody Concentrations
|
1622.8 EL.U/mL
Interval 1433.4 to 1837.1
|
63.3 EL.U/mL
Interval 56.3 to 71.2
|
1561.6 EL.U/mL
Interval 1359.2 to 1794.0
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7) post-vaccination period after any vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and had the symptom sheets filled in.
Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a local symptom irrespective of intensity grade.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=140 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=138 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=141 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Number of Subjects With Any Solicited Local Symptoms
Any pain
|
66 Participants
|
70 Participants
|
85 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any redness
|
83 Participants
|
81 Participants
|
83 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any swelling
|
64 Participants
|
50 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7) post-vaccination period after any vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and had the symptom sheets filled in.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5°C). Any= incidence of a general symptom irrespective of intensity grade and relationship to vaccination.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=140 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=138 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=141 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Number of Subjects With Any Solicited General Symptoms
Any drowsiness
|
105 Participants
|
91 Participants
|
107 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any irritability
|
108 Participants
|
101 Participants
|
113 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any loss of appetite
|
72 Participants
|
62 Participants
|
72 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any fever
|
53 Participants
|
38 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) post-vaccination period after any vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
An unsolicited AE was 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.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=141 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=139 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=141 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
|
61 Participants
|
52 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Month 0 to Month 3)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Outcome measures
| Measure |
GSK2202083A + Synflorix Group
n=141 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=139 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=141 Participants
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
5 Participants
|
6 Participants
|
3 Participants
|
Adverse Events
GSK2202083A + Synflorix Group
Serious events: 5 serious events
Other events: 130 other events
Deaths: 0 deaths
Infanrix Hexa + Menjugate Group
Serious events: 6 serious events
Other events: 129 other events
Deaths: 0 deaths
Infanrix Hexa + Synflorix Group
Serious events: 3 serious events
Other events: 137 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK2202083A + Synflorix Group
n=141 participants at risk
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=139 participants at risk
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=141 participants at risk
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.71%
1/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.00%
0/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.00%
0/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.71%
1/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.00%
0/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.00%
0/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.72%
1/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.00%
0/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.00%
0/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.71%
1/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
Infections and infestations
Bronchopneumonia
|
1.4%
2/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.72%
1/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.00%
0/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
Infections and infestations
Bronchitis
|
0.71%
1/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.72%
1/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.00%
0/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
Infections and infestations
Urinary tract infection
|
0.71%
1/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.72%
1/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.00%
0/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.72%
1/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.00%
0/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.00%
0/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.71%
1/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
Infections and infestations
Otitis media
|
0.00%
0/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.72%
1/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.00%
0/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.72%
1/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.00%
0/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.00%
0/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.71%
1/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
Other adverse events
| Measure |
GSK2202083A + Synflorix Group
n=141 participants at risk
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Menjugate Group
n=139 participants at risk
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
Infanrix Hexa + Synflorix Group
n=141 participants at risk
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
|
|---|---|---|---|
|
General disorders
Pain
|
46.8%
66/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
50.4%
70/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
60.3%
85/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
General disorders
Redness
|
58.9%
83/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
58.3%
81/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
58.9%
83/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
General disorders
Swelling
|
45.4%
64/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
36.0%
50/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
50.4%
71/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
General disorders
Drowsiness
|
74.5%
105/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
65.5%
91/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
75.9%
107/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
General disorders
Irritability
|
76.6%
108/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
72.7%
101/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
80.1%
113/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
General disorders
Loss of appetite
|
51.1%
72/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
44.6%
62/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
51.1%
72/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
General disorders
Temperature (Axillary)
|
37.6%
53/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
27.3%
38/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
43.3%
61/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
Infections and infestations
Rhinitis
|
7.8%
11/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
12.9%
18/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
12.1%
17/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
10/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
5.0%
7/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
7.1%
10/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
9/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
2.9%
4/139 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
0.00%
0/141 • Solicited local and general symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited adverse events: during the 31-day (Days 0-30) post-vaccination. Serious adverse events: during the entire study period (from Month 0 up to Month 3).
|
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