| Primary | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | 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) have been assessed by 22F-inhibition enzyme linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At 7-10 days after the first vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. | | OG001 | Pooled Synflorix I+II Group | For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group. |
| | | Title | Denominators | Categories |
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| Anti-1 | - ParticipantsOG000204
- ParticipantsOG001215
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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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| To demonstrate the immunological memory induced for anti-pneumococcal serotype 1 following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group. | ANOVA | | | | GMC ratio for anti-1 | 6.17 | | | 2-Sided | 95 | 5.03 | 7.58 | | | | | Non-Inferiority | The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 1. |
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| Secondary | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | 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) have been assessed by 22F-inhibition ELISA, presented as GMCs and expressed in μg/mL. The seropositivity cut-off value of the assay was an antibody concentration ≥ 0.05 μg/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | Prior to the first study vaccine dose (At Day 0) | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. | | OG001 | Pooled Synflorix I+II Group | For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group. |
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| Secondary | Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes | Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes ≥ the value of 8, presented as geometric mean titers (GMTs). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior to (Day 0) and 7-10 days after the first vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. | | OG001 | Pooled Synflorix I+II Group | For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group. |
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| Secondary | Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A | The vaccine pneumococcal cross-reactive serotypes 6A and 19A have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | Prior to (Day 0) and 7-10 days after the first vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. | | OG001 | Pooled Synflorix I+II Group | For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group. |
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| Secondary | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A | Seropositivity status was defined as the opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A (Opsono-16A and opsono-19A) ≥ the value of 8, presented as geometric mean titers (GMTs). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior to (Day 0) and 7-10 days after the first vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. | | OG001 | Pooled Synflorix I+II Group | For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group. |
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| Secondary | Antibody Concentrations Against Protein D (Anti-PD) | Anti-protein D (anti-PD) concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value of the assay was an antibody concentration ≥ 100 EL.U/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against protein D were available after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | Prior to (Day 0) and 7-10 days after the first vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. | | OG001 | Pooled Synflorix I+II Group | For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group. |
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| Secondary | Memory B-cell Detection for Vaccine Polysaccharides (PS) | B-cell detection for the pneumococcal serotype specific polysaccharides (1, 5, 6B, 18C, 19F, 23F and C) was tabulated for a subset of subjects from each group. The results are expressed as the frequencies of antigen-specific memory B-cells within the total memory B-cell population. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination. | Posted | | Mean | Standard Deviation | Memory B-cells | | Prior to (Day 0) and 7-10 days after the first vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix I Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol. | | OG001 | Synflorix II Group | |
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| Secondary | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs), expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At Month 12, one month after the second vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. |
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| Secondary | Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes | Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes ≥ the value of 8, presented as geometric mean titers (GMTs). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 12, one month after the second vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. |
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| Secondary | Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A | The vaccine pneumococcal cross-reactive serotypes 6A and 19A have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At Month 12, one month after the second vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. |
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| Secondary | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A | Seropositivity status was defined as the opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A (opsono-16A and opsono-19A) ≥ the value of 8, presented as geometric mean titers (GMTs). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 12, one month after the second vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. |
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| Secondary | Antibody Concentrations Against Protein D (Anti-PD) | Anti-protein D (anti-PD) concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value of the assay was an antibody concentration ≥ 100 EL.U/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against protein D were available after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Month 12, one month after the second vaccine dose | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. |
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| Secondary | Rabbit Complement-mediated Serum Bactericidal Activity Titers Against Neisseria Meningitidis Serogroups (rSBA-Men) | The Neisseria meningitidis serogroups assessed using rabbit complement were: A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY), presented as geometric mean titers (GMTs). The seropositivity cut-off of the assay was an antibody titer ≥ 8. | The analysis was performed on the ATP cohort for antibody persistence, which included all subjects with the vaccine administration documented, for whom assay results were available for antibodies against each considered antigen for the blood sample taken before the administration of Synflorix™ vaccine. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At 25-36 months post-vaccination in previous 107137 (NCT00496015) study | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure refers only to the primed groups. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-vaccination period | | | | ID | Title | Description |
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| OG000 | Synflorix I Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol. | | OG001 | Synflorix II Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment. |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure refers only to the unprimed group. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | 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 III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as causally related to study vaccination. This outcome measure refers only to the primed groups. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-vaccination period | | | | ID | Title | Description |
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| OG000 | Synflorix I Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol. | |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as causally related to study vaccination. This outcome measure refers only to the unprimed group. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | 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 III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. |
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| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | Within 31 days (Days 0-30) after each vaccination | | | | ID | Title | Description |
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| OG000 | Synflorix I Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol. | | OG001 | Synflorix II Group | |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | During the entire study period (from Day 0 up to Month 10 or Month 12) | | | | ID | Title | Description |
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| OG000 | Synflorix I Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol. | | OG001 | Synflorix II Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment. |
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| Secondary | Number of Nasopharyngeal Swabs With Streptococcus Pneumoniae (Vaccine Serotypes) | Positive cultures of S. pneumoniae Synflorix™ vaccine serotypes identified in the nasopharynx were recorded. | The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point. | Posted | | Number | | Swabs associated to specified bacteria | | At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. | | OG001 | Pooled Synflorix I+II Group | For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group. |
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| Secondary | Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes) | Positive cultures of S. pneumoniae cross- reactive serotypes identified in the nasopharynx were recorded. | The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point. | Posted | | Number | | Swabs associated to specified bacteria | | At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. | | OG001 | Pooled Synflorix I+II Group | For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group. |
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| Secondary | Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes) | Positive cultures of S. pneumoniae non- Synflorix™ vaccine, non-cross-reactive serotypes identified in the nasopharynx were recorded. | The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point. | Posted | | Number | | Swabs associated to specified bacteria | | At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. | | OG001 | Pooled Synflorix I+II Group | For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group. |
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| Secondary | Number of Nasopharyngeal Swabs With Haemophilus Influenzae | Positive cultures of H. influenzae identified in the nasopharynx were recorded. | The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point. | Posted | | Number | | Swabs associated to specified bacteria | | At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. | | OG001 | Pooled Synflorix I+II Group | For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group. |
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| Secondary | Number of Subjects With New Acquisition of S. Pneumoniae (Vaccine Serotypes) in Nasopharyngeal Swabs | The number of subjects with new acquisition of S. pneumoniae (Synflorix™ vaccine serotypes) detected in nasopharyngeal swabs was recorded. | The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point. | Posted | | Count of Participants | | Participants | | At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. | | OG001 | Pooled Synflorix I+II Group | For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group. |
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| Secondary | Number of Subjects With New Acquisition of S. Pneumoniae (Cross-reactive Serotypes) in Nasopharyngeal Swabs | The number of subjects with new acquisition of S. pneumoniae (cross-reactive serotypes) detected in nasopharyngeal swabs was recorded. | The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point. | Posted | | Count of Participants | | Participants | | At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. | | OG001 | Pooled Synflorix I+II Group | For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group. |
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| Secondary | Number of Subjects With New Acquisition of S. Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes) in Nasopharyngeal Swabs | The number of subjects with new acquisition of S. pneumoniae (non-vaccine and non-cross-reactive serotypes) detected in nasopharyngeal swabs was recorded. | The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point. | Posted | | Count of Participants | | Participants | | At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. | | OG001 | Pooled Synflorix I+II Group | For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group. |
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| Secondary | Number of Subjects With New Acquisition of H. Influenzae in Nasopharyngeal Swabs | The number of subjects with new acquisition of H. influenzae detected in nasopharyngeal swabs was recorded. | The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point. | Posted | | Count of Participants | | Participants | | At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age | | | | ID | Title | Description |
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| OG000 | Synflorix III Group | Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle. | | OG001 | Pooled Synflorix I+II Group | For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group. |
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