| 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 Booster According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | At Month 1, post-booster dose | | | | ID | Title | Description |
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| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG002 | Infanrix Hexa/NeisVac-C + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
| | | 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 |
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| Difference in percentage anti-PRP ≥ 0.15 μg/mL | | | | | Difference in percentage | 0 | | | 2-Sided | 95 | -3.27 | 2.84 | | | | | Non-Inferiority | Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10% | |
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| Primary | Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Completent (rSBA-MenC) | A seroprotected subject was defined as a subject with anti-rSBA-MenC titers greater than or equal to (≥) 1:8. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | At Month 1, post-booster dose | | | | ID | Title | Description |
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| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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| Secondary | Number of Seropositive Subjects for Anti-PRP | A seropositive subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | At Month 0, before the booster dose | | | | ID | Title | Description |
|---|
| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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| Secondary | Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off | The cut-off value of the assay was an anti-PRP antibody concentration ≥ 1 μg/mL. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | At Month 0 and Month 1, before and one month after booster dose | | | | ID | Title | Description |
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| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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| Secondary | Anti-PRP Antibody Concentrations | Concentrations were expressed as geometric mean concentrations (GMCs) for the cut-off value of ≥ 0.15 μg/mL. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At Month 0 and Month 1, before and one month after booster dose | | | | ID | Title | Description |
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| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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| Secondary | Number of Seroprotected Subjects Against rSBA-MenC | A seroprotected subject was defined as a subject with anti-rSBA-MenC antibody titers ≥ 1:8. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | At Month 0, before the booster dose | | | | ID | Title | Description |
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| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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| Secondary | Number of Seropositive Subjects for Anti-rSBA-MenC | A seropositive subject for anti-rSBA-MenC was defined as a subject with antibody titers greater than or equal to (≥) 1:128. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | At Month 0 and Month 1, before and one month after booster dose | | | | ID | Title | Description |
|---|
| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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| Secondary | Anti-rSBA-MenC Antibody Titres | Antibody titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 0 and Month 1, before and one month after booster dose | | | | ID | Title | Description |
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| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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| Secondary | Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values | The cut-off values assessed were ≥ 0.3 μg/mL and ≥ 2 μg/mL. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | At Month 0 and Month 1, before and one month after booster dose | | | | ID | Title | Description |
|---|
| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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| 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 Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At Month 0 and Month 1, before and one month after booster dose | | | | ID | Title | Description |
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| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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| Secondary | Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) | A seropositive subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL). | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | At Month 0 and Month 1, before and one month after booster dose | | | | ID | Title | Description |
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| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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| Secondary | Anti-D and Anti-T Antibody Concentrations | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.1 IU/mL. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Month 0 and Month 1, before and one month after booster dose | | | | ID | Title | Description |
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| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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| Secondary | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | The cut-off values assessed were 3.3 milli-international units per milliliter (mIU/mL), 10 mIU/mL and 100 mIU/mL. | The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | At Month 0 and Month 1, before and one month after booster dose | | | | ID | Title | Description |
|---|
| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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| Secondary | Anti-HBs Antibody Concentrations | Concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Month 0 and Month 1, before and after booster dose | | | | ID | Title | Description |
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| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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| Secondary | Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | A seropositive subject was defined as a subject with anti-polio type 1, 2 or 3 ≥ 1:8. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | At Month 0 and Month 1, before and one month after booster dose | | | | ID | Title | Description |
|---|
| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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| Secondary | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Titers were expressed as geometric mean titters (GMTs) for the seropositivity cut-off value of ≥ 1:8. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 0 and Month 1, before and one month after booster dose | | | | ID | Title | Description |
|---|
| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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| 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 and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | At Month 0 and Month 1, before and one month after booster dose | | | | ID | Title | Description |
|---|
| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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| Secondary | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value ≥ 5 EL.U/mL. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Month 0 and Month 1, before and one month after booster dose | | | | ID | Title | Description |
|---|
| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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| Secondary | Number of Subjects With Any Solicited Local Symptoms | Solicited local symptoms assessed included pain, redness and swelling. Any= all reports of the speecified symptom irrespective of intensity grade. | The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented and who had the symptoms sheet filled in. | Posted | | Count of Participants | | Participants | | During the 8-day (Days 0-7) post-booster period | | | | ID | Title | Description |
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| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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| Secondary | Number of Subjects With Any Solicited General Symptoms | Solicited general symptoms assessed included drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5º C). Any= all reports of the specified symptom irrespective of intensity grade and relationship to vaccination. | The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented and who had the symptoms sheet filled in. | Posted | | Count of Participants | | Participants | | During the 8-day (Days 0-7) post-booster period | | | | ID | Title | Description |
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| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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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 Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the 31-day (Days 0-30) post-booster period | | | | ID | Title | Description |
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| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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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 Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented. | Posted | | Count of Participants | | Participants | | After the booster dose of the study vaccine up to the study end (from Month 0 to Month 1) | | | | ID | Title | Description |
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| OG000 | GSK2202083A + Synflorix Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | | OG001 | Infanrix Hexa/Menjugate Group | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
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