| Primary | Number of Seroprotected Subjects for Anti-polyribosylribitol Phosphate (Anti-PRP). | A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). | The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course. | Posted | | Count of Participants | | Participants | | At Month 3 | | | | ID | Title | Description |
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| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
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| Primary | Number of Seropositive Subjects Against Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) | A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8. | The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course. | Posted | | Count of Participants | | Participants | | At Month 2 and Month 3. | | | | ID | Title | Description |
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| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
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| Secondary | Number of Subjects With Anti-PRP Concentrations Antibody Above the Cut-off. | The reference cut-off was ≥ 1.0 micrograms per milliliter (µg/mL). | The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course. | Posted | | Number | | Subjects | | At Month 3 | | | | ID | Title | Description |
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| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
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| Secondary | Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs. | The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL. | The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course. | Posted | | Number | | Subjects | | At Month 2 and Month 3. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
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| Secondary | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. | A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL). | The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course. | Posted | | Number | | Subjects | | At Month 3. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
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| Secondary | Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN). | A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL). | The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course. | Posted | | Number | | Subjects | | At Month 3. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
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| Secondary | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8. | The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course. | Posted | | Number | | Subjects | | At Month 3. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
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| Secondary | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes. | A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.2 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 4, 6B, 9V, 14, 18C, 19F and 23F. | The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course. | Posted | | Number | | Subjects | | At Month 3 | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
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| Secondary | Concentrations for Anti-PRP. | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL. | The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Month 3. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
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| Secondary | Titers for rSBA-MenC. | Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off value was ≥ 1:8. | The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | At Month 2 and Month 3. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
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| Secondary | Concentrations for Anti-PSC. | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL. | The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Month 2 and Month 3. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
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| Secondary | Concentrations for Anti-T and Anti-D. | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL. | The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Month 3. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
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| Secondary | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity reference cut-off value was ≥ 5 EL.U/mL. | The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Month 3. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
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| Secondary | Titers for Anti-polio 1, 2 and 3. | Titers were expressed as geometric mean titers (GMTs). The seropositivity reference cut-off value was ≥ 1:8. | The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | At Month 3. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
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| Secondary | Concentrations for Anti-PNE Serotypes. | Concentrations were expressed as geometric mean concentreations (GMCs). The seropositivity reference cut-off value was ≥ 0.2 µg/mL. | The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Month 3. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
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| Secondary | Number of Seroprotected Subjects for Anti-PRP. | A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). | The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course. | Posted | | Number | | Subjects | | At Month 10 and Month 11. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
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| Secondary | Number of Seropositive Subjects Against rSBA-MenC. | A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8. | The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course. | Posted | | Number | | Subjects | | At Month 10 and Month 11. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
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| Secondary | Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs. | The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL. | The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course. | Posted | | Number | | Subjects | | At Month 10 and Month 11. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
|
| Secondary | Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies. | A seropositive subject was defined as a vaccinated subject who had anti-D (ELISA) and anti-T antibody concentrations ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay). | The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course. | Posted | | Number | | Subjects | | At Month 10. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
|
| Secondary | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL). | The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course. | Posted | | Number | | Subjects | | At Month 10. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
|
| Secondary | Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3. | A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8. | The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course. | Posted | | Number | | Subjects | | At Month 10. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
|
| Secondary | Concentrations for Anti-PRP. | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL. | The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course. | Posted | | Geometric Mean | 95% Confidence Interval | µg /mL | | At Month 10 and Month 11. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
|
| Secondary | Titers for rSBA-MenC. | Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off value was ≥ 1:8. | The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | At Month 10 and Month 11. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
|
| Secondary | Concentrations for Anti-PSC. | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL. | The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course. | Posted | | Geometric Mean | 95% Confidence Interval | µg /mL | | At Month 10 and Month 11. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
|
| Secondary | Concentrations for Anti-T and Anti-D. | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay). | The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Month 10. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
|
| Secondary | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity reference cut-off value was ≥ 5 EL.U/mL. | The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Month 10. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
|
| Secondary | Titers for Anti-polio 1, 2 and 3. | Titers were expressed as geometric mean titers (GMTs). The seroprotection reference cut-off value was ≥ 1:8. | The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | At Month 10. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
|
| Secondary | Number of Subjects With a Booster Response to rSBA-MenC Antibodies. | Booster response defined as: for initially seronegative subjects, antibody titre ≥ 1:32 at post-booster (Month 11); for initially seropositive subjects, antibody titres at post-booster ≥ 4 fold the pre-booster. | The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course. | Posted | | Number | | Subjects | | At Month 11 | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
|
| Secondary | Number of Subjects With a Booster Response to Anti-PRP Antibodies. | Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 0.6 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster. | The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course. | Posted | | Number | | Subjects | | At Month 11 | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
|
| Secondary | Number of Subjects With a Booster Response to Anti-PSC Antibodies. | Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 1.2 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster. | The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course. | Posted | | Number | | Subjects | | At Month 11 | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
|
| Secondary | Number of Subjects Reporting Any Solicited Local Symptoms. | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. | The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course. | Posted | | Number | | Subjects | | During the 8-day (Days 0-7) | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
|
| Secondary | Number of Subjects Reporting Any Solicited Local Symptoms. | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. | The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose. | Posted | | Number | | Subjects | | During the 8-day (Days 0-7) | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
|
| Secondary | Number of Subjects Reporting Any Solicited General Symptoms. | Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade. | The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course. | Posted | | Number | | Subjects | | During the 8-day (Days 0-7) | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
|
| Secondary | Number of Subjects Reporting Any Solicited General Symptoms. | Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade. | The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose. | Posted | | Number | | Subjects | | During the 8-day (Days 0-7) | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
|
| Secondary | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination. | The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course. | Posted | | Number | | Subjects | | Within the 31-day (Days 0-30) follow up period after vaccination. | | | | ID | Title | Description |
|---|
| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
|
| Secondary | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination. | The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose. | Posted | | Number | | Subjects | | Within the 31-day (Days 0-30) follow up period after vaccination. | | | | ID | Title | Description |
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| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
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| Secondary | Number of Subjects Reporting Any Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available. | Posted | | Number | | Subjects | | During the entire study period (Month 0 to Month 11) | | | | ID | Title | Description |
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| OG000 | GSK2197870A Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2 and a booster dose of Menitorixâ„¢ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh. | | OG001 | Pediacel Group | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacelâ„¢ vaccine at Months 0, 1 and 2, 2 doses of Prevenarâ„¢ vaccine at Months 0 and 2, 2 doses of Menjugateâ„¢ vaccine at Months 1 and 2 and a booster dose of Menitorixâ„¢ at Month 10. All vaccines were administered intramuscularly. Pediacelâ„¢ and Menitorixâ„¢ vaccines were administered in the right upper anterolateral thigh and Prevenarâ„¢ vaccine in the left upper anterolateral thigh and Menjugateâ„¢ vaccine in the left lower anterolateral thigh. |
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