| Primary | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value. | The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures, with no elimination criteria) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase | Posted | | Count of Participants | | Participants | | One month after the 3-dose primary vaccination course (at Month 5) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 | ActHIB Group | During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIBâ„¢ vaccine co-administered with the Pediarixâ„¢ and Prevnarâ„¢ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrixâ„¢ or ActHIBâ„¢ concomitantly with one dose of Prevnarâ„¢. During Primary Phase, ActHIBâ„¢ was administered intramuscularly (IM) in the right upper thigh, and the Pediarixâ„¢ and Prevnarâ„¢ vaccines IM in the left upper and lower thighs, respectively. |
| | | Title | Denominators | Categories |
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| Primary | Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | One month after the 3-dose primary vaccination course (at Month 5) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
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| Primary | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | One month after the 3-dose primary vaccination course (at Month 5) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
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| Primary | Number of Subjects Reporting Any Grade 3 Symptoms | "Symptoms" were defined as solicited local and general symptoms and unsolicited adverse events (AEs). A "Grade 3" symptom was defined as any symptom that prevented normal everyday activity. "Any" was defined as an occurrence of any specified symptom regardless of intensity grade. This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase. | Posted | | Count of Participants | | Participants | | During the 4-day follow-up period after each primary vaccine dose | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 |
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| Primary | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value | The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB/ActHIB groups . | The Fourth Dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies 1 month (31 to 48 days) after the administration of the fourth dose. | Posted | | Count of Participants | | Participants | | One month after the fourth dose (at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
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| Secondary | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values | rSBA-MenC antibody cut-off values for this outcome were 1:8 and 1:128. | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Count of Participants | | Participants | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers | Titers are presented as geometric mean titers (GMTs). | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
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| Secondary | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values | rSBA-MenY antibody cut-off values for this outcome measure were 1:8 and 1:128. | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Count of Participants | | Participants | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers | Titers are presented as geometric mean titers (GMTs). | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
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| Secondary | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4 | A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (<) 1:128. | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Count of Participants | | Participants | | One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4 | A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (<) 1:128. | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Count of Participants | | Participants | | One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
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| Secondary | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values | Anti-PSC antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL. | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Count of Participants | | Participants | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Anti-polysaccharide C (Anti-PSC) Antibody Concentrations | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
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| Secondary | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values | Anti-PSY antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL. | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Count of Participants | | Participants | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL) | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
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| Secondary | Number of Subjects Reporting Medically Attended Visits | A medically attended visit was defined as an hospitalization, an emergency room visit or a visit to or from medical personnel. This Outcome Measure only concerns subjects in the Menomune Group. | The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase. | Posted | | Count of Participants | | Participants | | During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Menomune Group | Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomuneâ„¢ at Day 0. Menomuneâ„¢ was administered subcutaneously in the left deltoid region. |
| |
| Secondary | Number of Subjects Reporting Rash | An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns subjects in the Menomune Group. | The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase. | Posted | | Count of Participants | | Participants | | During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Menomune Group | Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomuneâ„¢ at Day 0. Menomuneâ„¢ was administered subcutaneously in the left deltoid region. |
| |
| Secondary | Number of Subjects Reporting 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 subject . This Outcome Measure only concerns subjects in the Menomune Group. | The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase. | Posted | | Count of Participants | | Participants | | During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Menomune Group | Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomuneâ„¢ at Day 0. Menomuneâ„¢ was administered subcutaneously in the left deltoid region. |
| |
| Secondary | Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values | Anti-PRP antibody cut-off values for this outcome were 0.15 µg/mL and 1.0 µg/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Count of Participants | | Participants | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | |
|
| Secondary | Anti-PRP Antibody Concentrations | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | |
|
| Secondary | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.05 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Count of Participants | | Participants | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.2 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Count of Participants | | Participants | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.5 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Count of Participants | | Participants | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL) | The anti-diphtheria and anti-tetanus antibody cut-off value for this outcome was ≥ 0.1 IU/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups. | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Count of Participants | | Participants | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Anti-diphtheria and Anti-tetanus Antibody Concentrations | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL) | This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Count of Participants | | Participants | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | |
|
| Secondary | Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL | This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Count of Participants | | Participants | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 |
|
| Secondary | Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations | Concentrations of antibodies are presented as GMCs expressed as EL.U/mL. Results for one month after the 3-dose primary vaccination course (at Month 5) are presented under the Primary Outcome Measures section. This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | Prior to the primary vaccination course (at Day 0) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 | This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Count of Participants | | Participants | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 | ActHIB Group |
|
| Secondary | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Titers are presented as geometric mean titers (GMTs). This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 |
|
| Secondary | Number of Subjects With Vaccine Response to PT, FHA and PRN | Vaccine response to PT/FHA/PRN was defined as, for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month post-primary vaccination course, and, for initially seropositive subjects, antibody concentration one month post-primary vaccination course ≥ 1-fold the pre-vaccination antibody concentration. A seronegative/seronegative subject was defined as a subject with antibody concentration \ | The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase. | Posted | | Count of Participants | | Participants | | One month after the 3-dose primary vaccination course (at Month 5) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Solicited local symptoms were pain, redness and swelling at injection site. "Any" = any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling larger than (>) 10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling > 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase. | Posted | | Count of Participants | | Participants | | Within 4 days (Day 0-3) after the 3-dose primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Solicited local symptoms were pain, redness and swelling at injection site. "Any" = any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling larger than (>) 10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling > 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase. | Posted | | Count of Participants | | Participants | | Within 8 days (Day 0-7) after the 3-dose primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. "Any" = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; "Grade 3" for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; "Grade 3" Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); "Grade 2 or 3" fever = rectal temperature higher than (>) 39°C; "Grade 3" fever = rectal temperature > 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase. | Posted | | Count of Participants | | Participants | | Within 4 days (Day 0-3) after the 3-dose primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. "Any" = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; "Grade 3" for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; "Grade 3" Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); "Grade 2 or 3" fever = rectal temperature higher than (>) 39°C; "Grade 3" fever = rectal temperature > 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups | The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase. | Posted | | Count of Participants | | Participants | | Within 8 days (Day 0-7) after the 3-dose primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase. | Posted | | Count of Participants | | Participants | | From Dose 1 (at Day 0) through Day 30 following the last vaccine dose administered (Day 30 post Month 4 vaccination for MenHibrix and ActHIB groups, Day 30 post Month 1 for Menomune Group). | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects Reporting 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 with at least one vaccine administration documented during the primary phase. | Posted | | Count of Participants | | Participants | | During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination). | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 |
|
| Secondary | Number of Subjects Reporting 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. This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase. | Posted | | Count of Participants | | Participants | | From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine. | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | |
|
| Secondary | Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase. | Posted | | Count of Participants | | Participants | | From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 | ActHIB Group | |
|
| Secondary | Number of Subjects Reporting Rash | An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns the MenHibrix and ActHIB groups . | The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase. | Posted | | Count of Participants | | Participants | | From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine. | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 | ActHIB Group | |
|
| Secondary | Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses | Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups. | The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase. | Posted | | Count of Participants | | Participants | | From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine. | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) | Fourth dose responses to rSBA-MenC and rSBA-MenY were defined as follows (Definition 1):
- Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: < 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after fourth dose (post-fourth dose antibody titer ≥1:32),
- Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after fourth dose.
| The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Count of Participants | | Participants | | One month post fourth dose vaccination (at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) | Fourth dose responses to rSBA-MenC and rSBA-MenY were also assessed using a second definition (Definition 2):
- Post-fourth dose rSBA antibody titers ≥1:32 in subjects seronegative at the pre-fourth dose time point (rSBA antibody titers < 1:8),
- At least (i.e., greater than or equal to) a 4-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8 but < 1:128,
- At least (i.e., greater than or equal to) a 2-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:128.
| The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Count of Participants | | Participants | | One month post fourth dose vaccination (at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) | Fourth dose responses to hSBA-MenC and hSBA-MenY were defined as follows (Definition 1):
- Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: < 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after the fourth dose (post-fourth dose antibody titer ≥1:16),
- Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after the fourth dose.
| The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Count of Participants | | Participants | | One month post fourth dose vaccination (at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | Menhibrix Group | Subjects of 6-12 weeks of age received 3 doses of Menhibrix vaccine co-administered with Pediarix and Prevnar vaccines during the primary vaccination phase. Subjects received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the primary phase, Menhibrix vaccine was administered intramuscularly into the right upper thigh. Pediarix and Prevnar vaccines were administered intramuscularly into the left upper thigh and the left lower thigh, respectively. In the fourth dose phase, Menhibrix vaccine was administered by the same route at the same vaccination site and Prevnar was administered intramuscularly in the left upper thigh. |
|
| Secondary | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) | Fourth dose responses to hSBA-MenC and hSBA-MenY were also assessed using a second definition (Definition 2):
- Post-fourth dose hSBA antibody titers ≥1:16 in subjects seronegative at the pre-fourth dose time point (hSBA antibody titers < 1:8),
- At least (i.e., greater than or equal to) a 4-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:4 but < 1: 8,
- At least (i.e., greater than or equal to) a 2-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8.
| The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Count of Participants | | Participants | | One month post fourth dose vaccination (at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Streptococcus pneumoniae antibody cut-off values assessed was ≥0.05 µg/mL for the 7 serotypes in Prevnar vaccine. Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Count of Participants | | Participants | | One month after fourth dose vaccination (at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Streptococcus pneumoniae antibody cut-off values assessed was ≥0.2 µg/mL for the 7 serotypes in Prevnar vaccine. Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Count of Participants | | Participants | | One month after fourth dose vaccination (at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Streptococcus pneumoniae antibody cut-off values assessed was ≥0.5 µg/mL for the 7 serotypes in Prevnar vaccine. Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Count of Participants | | Participants | | One month after fourth dose vaccination (at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | One month post fourth dose vaccination (at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | Menhibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PRP antibody cut-off values assessed were ≥0.15 µg/mL and ≥1.0 µg/mL. | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Count of Participants | | Participants | | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 |
|
| Secondary | Anti-PRP Antibody Concentrations | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL) | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 |
|
| Secondary | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | rSBA-MenC antibody cut-off values assessed were ≥1:8 and ≥1:128 | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Count of Participants | | Participants | | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | Menhibrix Group | Subjects of 6-12 weeks of age received 3 doses of Menhibrix vaccine co-administered with Pediarix and Prevnar vaccines during the primary vaccination phase. Subjects received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the primary phase, Menhibrix vaccine was administered intramuscularly into the right upper thigh. Pediarix and Prevnar vaccines were administered intramuscularly into the left upper thigh and the left lower thigh, respectively. In the fourth dose phase, Menhibrix vaccine was administered by the same route at the same vaccination site and Prevnar was administered intramuscularly in the left upper thigh. | | OG001 | ActHIB/ActHIB Group | |
|
| Secondary | rSBA-MenC Antibody Titers | Titers are presented as geometric mean titers (GMTs). | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 | ActHIB/ActHIB Group |
|
| Secondary | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | rSBA-MenY antibody cut-off values assesse were ≥1:8 and ≥1:128. | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Count of Participants | | Participants | | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | |
|
| Secondary | rSBA-MenY Antibody Titers | Titers are presented as geometric mean titers (GMTs). | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 | ActHIB/ActHIB Group |
|
| Secondary | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenC antibody cut-off values assessed were ≥1:4 and ≥1:8. | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Count of Participants | | Participants | | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | |
|
| Secondary | hSBA-MenC Antibody Titers | Titers are presented as geometric mean titers (GMTs). | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 | ActHIB/ActHIB Group |
|
| Secondary | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenY antibody cut-off values assessed were ≥1:4 and ≥1:8. | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Count of Participants | | Participants | | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | |
|
| Secondary | hSBA-MenY Antibody Titers | Titers are presented as geometric mean titers (GMTs). | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 | ActHIB/ActHIB Group |
|
| Secondary | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL. | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Count of Participants | | Participants | | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 |
|
| Secondary | Anti-PSC Antibody Concentrations | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 |
|
| Secondary | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL. | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Count of Participants | | Participants | | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 |
|
| Secondary | Anti-PSY Antibody Concentrations | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL) | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 |
|
| Secondary | Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL) | | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Count of Participants | | Participants | | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 | ActHIB/ActHIB Group | |
|
| Secondary | Anti-tetanus Antibody Concentrations | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL). | The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 |
|
| Secondary | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. "Any"= any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling >10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling >30 mm; "Grade 2" limb circumference (LC) = LC >20 mm; "Grade 3" LC = LC >40 mm | The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase | Posted | | Count of Participants | | Participants | | Within 4 days (Day 0-3) after fourth dose vaccination | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. "Any"= any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling >10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling >30 mm; "Grade 2" limb circumference (LC) = LC >20 mm; "Grade 3" LC = LC >40 mm | The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase. | Posted | | Count of Participants | | Participants | | Within 8 days (Day 0-7) after fourth dose vaccination | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. "Any"= any report of the specified symptom irrespective of intensity and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness & Loss of appetite = interfered with normal activity; "Grade 3" for Drowsiness, Irritability/Fussiness = prevented normal activity; "Grade 3" Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); "Grade 2 or 3" for fever = T >39.0°C; "Grade 3" for fever = T >40.0°C | The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase. | Posted | | Count of Participants | | Participants | | Within 4 days (Day 0-3) after fourth dose vaccination | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
|
| Secondary | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. "Any"= any report of the specified symptom irrespective of intensity and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness & Loss of appetite = interfered with normal activity; "Grade 3" for Drowsiness, Irritability/Fussiness = prevented normal activity; "Grade 3" Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); "Grade 2 or 3" for fever = T >39.0°C; "Grade 3" for fever = T >40.0°C | The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase. | Posted | | Count of Participants | | Participants | | Within 8 days (Day 0-7) after fourth dose vaccination | | | | ID | Title | Description |
|---|
| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. |
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| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase. | Posted | | Count of Participants | | Participants | | During the 31-day follow-up period following the fourth dose | | | | ID | Title | Description |
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| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | |
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| Secondary | Number of Subjects Reporting 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 Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase. | Posted | | Count of Participants | | Participants | | During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination). | | | | ID | Title | Description |
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| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 | ActHIB/ActHIB Group |
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| Secondary | Number of Subjects Reporting New Onset of Chronic Illness(es) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase. | Posted | | Count of Participants | | Participants | | From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up | | | | ID | Title | Description |
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| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 | ActHIB/ActHIB Group | Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIBâ„¢ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIBâ„¢ and a concomitant fourth dose of Prevnarâ„¢. ActHIBâ„¢ and Prevnarâ„¢ were administered intramuscularly in the right and left upper thighs, respectively. |
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| Secondary | Number of Subjects Reporting Rash | An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. | The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase. | Posted | | Count of Participants | | Participants | | From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up | | | | ID | Title | Description |
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| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 | ActHIB/ActHIB Group | Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIBâ„¢ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIBâ„¢ and a concomitant fourth dose of Prevnarâ„¢. ActHIBâ„¢ and Prevnarâ„¢ were administered intramuscularly in the right and left upper thighs, respectively. |
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| Secondary | Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses | Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups. | The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase. | Posted | | Count of Participants | | Participants | | From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up | | | | ID | Title | Description |
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| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 |
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| Secondary | Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s) | Large injection site reactions were defined as either swelling with a diameter of > 30 mm or a > 30 mm increase in the circumference of the mid-thigh when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interfered with or prevented everyday activities (for example, active playing, eating, sleeping). | The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase. | Posted | | Count of Participants | | Participants | | Within 4 days (Day 0-3) and within 8 days (Day 0-7) following the fourth dose | | | | ID | Title | Description |
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| OG000 | MenHibrix Group | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrixâ„¢ co-administered with Pediarixâ„¢ and Prevnarâ„¢ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrixâ„¢ during the Primary Phase received one dose of MenHibrixâ„¢ and one concomitant dose of Prevnarâ„¢ at Month 10-13. During Primary Phase, MenHibrixâ„¢ was administered intramuscularly (IM) in the right upper thigh, and Pediarixâ„¢ and Prevnarâ„¢ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrixâ„¢ was administered by the same route and at the same site as during Primary Phase, and Prevnarâ„¢ was administered IM in the left upper thigh. | | OG001 |
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