| Primary | Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP) | 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). | 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. | Posted | | Count of Participants | | Participants | | At Month 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| | | Title | Denominators | Categories |
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| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | Difference in percentage | -0.76 | | | 2-Sided | 95 | -4.21 | 2.22 | | | | | Non-Inferiority | Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10% . | |
|
| Primary | Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Complement (rSBA-MenC) | A seroprotected subject was defined as a subject with rSBA-MenC titers greater than or equal to (≥) 1:8. | 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. | Posted | | Count of Participants | | Participants | | At Month 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Anti-PRP Antibody Concentrations | Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.15 µg/mL. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Months 0 and 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Antibody Titers Against rSBA-MenC | The seroprotection cut-off value of the assay was an antibody titer ≥ 1:8. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Months 0 and 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Number of Seropositive Subjects for Anti-polysaccharide Neisseria Meningitidis Serogroup C (Anti-PSC) | A seropositive subject was defined as a subject with anti-PSC antibody concentration ≥ 0.3 µg/mL. | 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. | Posted | | Count of Participants | | Participants | | At Month 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Anti-PSC Antibody Concentrations | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 µg/mL. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Months 0 and 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) | A seroprotected subject was defined as a subject with anti-D or anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL). | 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. | Posted | | Count of Participants | | Participants | | At Month 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Anti-D and Anti-T Antibody Concentrations | Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.1 IU/mL. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Month 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | 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). | 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. | Posted | | Count of Participants | | Participants | | At Month 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Months 0 and 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | 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. | 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. | Posted | | Count of Participants | | Participants | | At Month 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs) | 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. | 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. | Posted | | Count of Participants | | Participants | | At Month 3 | | | | ID | Title | Description |
|---|
| OG000 | 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 Synflorixâ„¢ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarixâ„¢ vaccine at 2 and 3 months of age. GSK2202083A and Synflorixâ„¢ vaccines were administered intramuscularly into the right and left thigh, while Rotarixâ„¢ vaccine was administered orally. | | OG001 | Infanrix Hexa + Menjugate Group |
|
| Secondary | Anti-HBs Antibody Concentrations | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Month 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3 | A seroprotected subject was defined as a subject with anti-polio type 1, 2 or 3 antibody titers ≥ 1:8. | 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. | Posted | | Count of Participants | | Participants | | At Month 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Anti-polio Types 1, 2 and 3 Antibody Titers | Titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | 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. | 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. | Posted | | Count of Participants | | Participants | | At Month 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Anti-pneumo Antibody Concentrations | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.05 µg/mL. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Month 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Number of Seropositive Subjects for Anti-protein D (Anti-PD) | A seropositive subject was defined as a subject with anti-PD concentrations ≥ 100 EL.U/mL. | 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. | Posted | | Count of Participants | | Participants | | At Month 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Anti-PD Antibody Concentrations | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 100 EL.U/mL. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Month 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Number of Subjects With Any Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a local symptom irrespective of intensity grade. | 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. | Posted | | Count of Participants | | Participants | | During the 8-day (Days 0-7) post-vaccination period after any vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Subjects With Any Solicited General Symptoms | 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. | 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. | Posted | | Count of Participants | | Participants | | During the 8-day (Days 0-7) post-vaccination period after any vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) | 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. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | | Count of Participants | | Participants | | During the 31-day (Days 0-30) post-vaccination period after any vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | | Count of Participants | | Participants | | During the entire study period (from Month 0 to Month 3) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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