| Primary | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination | Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were measured by 22F-inhibition Enzyme-Linked ImmunSorbent Assay (ELISA); presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was greater than or equal to (≥) 0.05 μg/mL. | The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. | | OG002 | Prevenar + Pediacel Group | Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid. |
| | | Title | Denominators | Categories |
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| Anti-1 | - ParticipantsOG000181
- ParticipantsOG001178
- ParticipantsOG002178
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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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| The 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 1. | ANOVA | | | | GMC ratio | 0.89 | | | 2-Sided | 95 | 0.74 | 1.07 | | | | | Non-Inferiority | Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% confidence interval (CI) of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 1. |
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| Primary | Antibody Concentration Against Protein D (PD) - Primary Vaccination | Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. | The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Primary Vaccination | Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL. | The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III. | Posted | | Count of Participants | | Participants | | At Month 3, one month after the administration of the third vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination | Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8. | The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 3, one month after the administration of the third vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Primary Vaccination. | Antibody concentrations against the cross- reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL. | The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III. | Posted | | Count of Participants | | Participants | | At Month 3, one month after the administration of the third vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Primary Vaccination | Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations (Anti-6A and -19A) were measured by 22F-inhibition ELISA; presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL. | The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Month 3, one month after the administration of the third vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Primary Vaccination. | Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 8. | The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 3, one month after the administration of the third vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Primary Vaccination | Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seropositivity cut-off value was greater than or equal to (≥) 0.1 IU/mL. | The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Month 3, one month after the administration of the third vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Primary Vaccination | Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL. | The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Month 3, one month after the administration of the third vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination | Anti-PT, anti-FHA and anti-PRN antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value was ≥ 5 EL.U/mL. | The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Month 3, one month after the administration of the third vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Primary Vaccination. | Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). A seroprotected subject was a subject whose antibody ChemiLuminescence ImmunoAssay (CLIA) concentration was greater than or equal to the cut-off value ≥ 10 milli-international units per milliliter (mIU/mL). Note: investigations on the quality of some serology assays revealed that the anti-HBs ELISA overestimated concentration between 10-100 mIU/mL while values > 100 mIU/mL were confirmed valid. Therefore, all available samples at one month post-dose III and one month post-dose IV timepoints for which the anti-HBs antibody concentration was between 10-100 mIU/mL by in-house ELISA, were retested by the commercial assay Centaur™, an FDA-approved and CE-marked CLIA with a cut-off defining seropositivity of 6.2 mIU/mL. Anti-HBs seroprotection was redefined as in-house ELISA concentration > 100 mIU/mL or CLIA concentration > 10 mIU/mL. | The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Month 3, one month after the administration of the third vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. |
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| Secondary | Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination. | Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8. | The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 3, one month after the administration of the third vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. | |
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| Secondary | Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination | Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL. | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Count of Participants | | Participants | | Prior to (Month 9) and one month after the administration of the booster dose (Month 10) | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination | Anti-pneumococcal serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL. | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | Prior (Month 9) to and one month after the administration of the booster dose (Month 10) | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination | Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8. | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior (Month 9) to and one month after the administration of the booster dose(Month 10) | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. | | OG002 |
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| Secondary | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination. | Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL. | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Count of Participants | | Participants | | Prior (Month 9) to and one month after the administration of the booster dose(Month 10) | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination | Anti-pneumococcal cross-reactive serotype 6A and 19A antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL. | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | Prior (Month 9) to and one month after the administration of the booster dose (Month 10) | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination. | Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8. | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior to (Month 9) and one month after the administration of the booster dose (Month 10) | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. | | OG002 |
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| Secondary | Concentrations of Antibodies Against Protein D (Anti-PD) - Booster Vaccination. | Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | Prior (Month 9) to and one month after (Month 10) the administration of the booster dose | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination. | Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seropositivity cut-off value was greater than or equal to (≥) 0.1 IU/mL. | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Prior to (Month 9) and one month after (Month 10) the administration of the booster dose | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Booster Vaccination | Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL. | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | Prior to (Month 9) and one month after (Month 10) the administration of the booster dose | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination. | Anti-PT, anti-FHA and anti-PRN antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value was ≥ 5 EL.U/mL. | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | Prior (Month 9) to and one month after (Month 10) the administration of the booster dose | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Booster Vaccination. | Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). A seroprotected subject was a subject whose antibody ChemiLuminescence ImmunoAssay (CLIA) concentration was greater than or equal to the cut-off value ≥ 10 milli-international units per milliliter (mIU/mL). Note: investigations on the quality of some serology assays revealed that the anti-HBs ELISA overestimated concentration between 10-100 mIU/mL while values > 100 mIU/mL were confirmed valid. Therefore, all available samples at one month post-dose III and one month post-dose IV timepoints for which the anti-HBs antibody concentration was between 10-100 mIU/mL by in-house ELISA, were retested by the commercial assay Centaur™, an FDA-approved and CE-marked CLIA with a cut-off defining seropositivity of 6.2 mIU/mL. Anti-HBs seroprotection was redefined as in-house ELISA concentration > 100 mIU/mL or CLIA concentration > 10 mIU/mL. | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | Prior (Month 9) to and one month after (Month 10) the administration of the booster dose | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. |
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| Secondary | Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination. | Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8. | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior (Month 9) to and one month after (Month 10) the administration of the booster dose | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. | | OG002 |
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| Secondary | Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination. | A booster responder to PT/FHA/PRN was defined as a subject with antibodies concentration ≥ 5 EL.U/mL against PT/FHA/PRN in subjects who were initially seronegative for anti-PT/FHA/PRN antibodies (i.e., subjects with anti-PT/FHA/PRN antibody concentrations < 5 EL.U/mL), or antibody concentration ≥ 2 fold the pre-vaccination antibody concentration in subjects who were initially seropositive (i.e., subjects with anti-PT/FHA/PRN antibody concentrations ≥ 5 EL.U/mL). | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Count of Participants | | Participants | | One month after (Month 10) the administration of the booster dose | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL. | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Count of Participants | | Participants | | At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - 12 Months After Booster Dose. | Anti-pneumococcal serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL. | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose. | Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8. | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. | |
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| Secondary | Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - 12 Months After Booster Dose. | Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL. | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Count of Participants | | Participants | | At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - 12 Months After Booster Dose. | Anti-pneumococcal cross-reactive serotype 6A and 19A antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL. | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - 12 Months After Booster Dose. | Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8. | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. | | OG002 |
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| Secondary | Concentrations of Antibodies Against Protein D (Anti-PD) - 12 Months After Booster Dose. | Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. | The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age) | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination. | Positive cultures of H. influenzae* (HI) and S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), M9 (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). *Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay. | The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose. | Posted | | Count of Participants | | Participants | | One month after the third dose (Month 3), prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21) | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination. | Positive cultures of S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). | The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose. | Posted | | Count of Participants | | Participants | | One month after the third dose (Month 3), prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21) | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination. | Acquisition of new H. influenzae* (HI) and S. pneumoniae (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). *Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay. | The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose. | Posted | | Count of Participants | | Participants | | Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21) | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination. | Acquisition of new S. pneumonia (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). | The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose. | Posted | | Count of Participants | | Participants | | Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21) | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Number of Subjects With Solicited Local Symptoms - Primary Vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling spreading beyond (>) 30 millimeters from injection site. | The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-vaccination period following each dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Number of Subjects With Solicited General Symptoms - Primary Vaccination | Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Related symptom was defined as a general symptom assessed by the investigator as causally related to study vaccination. | The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-vaccination period following each dose and across doses | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Vaccination. | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. | The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose. | Posted | | Count of Participants | | Participants | | Within the 31-day (Days 0-30) post-primary vaccination | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. | |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. | The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose. | Posted | | Count of Participants | | Participants | | Throughout the entire study period (up to Month 21) | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. | | OG002 | Prevenar + Pediacel Group |
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| Secondary | Number of Subjects With Solicited Local Symptoms -Booster Vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling > 30 millimeters from injection site. | The Booster Total Vaccinated cohort included all subjects vaccinated with the booster dose. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-vaccination period following booster dose | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. | |
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| Secondary | Number of Subjects With Solicited General Symptoms - Booster Vaccination. | Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Related symptom was defined as a general symptom assessed by the investigator as causally related to study vaccination. | The Booster Total Vaccinated cohort included all subjects vaccinated with the booster dose. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-vaccination period following booster dose | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. |
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| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Vaccination. | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. | The Booster Total Vaccinated cohort included all subjects vaccinated with the booster dose. | Posted | | Count of Participants | | Participants | | Within the 31-day (Days 0-30) after booster vaccination | | | | ID | Title | Description |
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| OG000 | Synflorix + Infanrix Hexa Group | Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid. | | OG001 | Synflorix + Pediacel Group | Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid. | |
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