| Primary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off. | The cut-off for the assay was greater than or equal to (≥) 1:8. The analysis was based only on subjects receiving Nimenrix vaccination at Day 0. | The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | 1 month after vaccination with Nimenrix vaccine (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. |
| | | Title | Denominators | Categories |
|---|
| rSBA-MenA, M1 | - ParticipantsOG000193
- ParticipantsOG001183
| |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Demonstration of the non-inferiority of Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup A, at month 1. | | | | | Difference in percentages | 1.64 | | | 2-Sided | 95 | -0.33 | 4.71 | | | | | Non-Inferiority | Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%. |
|
| Primary | Anti-PT, Anti-FHA and Anti-PRN Concentrations | The analysis was based only on subjects receiving Infanrix-hexa vaccination. The results were calculated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.The analysis for the primary outcome was based only on subjects receiving Infanrix-hexa vaccination at month 1. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | 1 month after the first vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. |
| |
| Primary | Number of Subjects With Anti-HBs Concentrations ≥ the Cut-off | The cut-off for the assay was greater than or equal to (≥) 10 milli-interantional units per milliliter (mIU/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. The analysis for the primary outcome measure was based only on subjects receiving Infanrix-hexa vaccination at Month 1. | Posted | | Count of Participants | | Participants | | 1 month after vaccination with Nimenrix vaccine (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrix and Infanrix-hexa vaccines at Day 0. | | OG001 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexa vaccine at Day 0, followed one month later by 1 dose of Nimenrix vaccine. |
| |
| Primary | Number of Subjects With Anti-PRP Concentrations ≥ the Cut-off | The cut-off for the assay was ≥ 1μg/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.The analysis for the primary outcome was based only on subjects receiving Infanrix-hexa vaccination at Day 0. | Posted | | Count of Participants | | Participants | | 1 month after vaccination with Nimenrix vaccine (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. |
| |
| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | The cut-off values for the assay were ≥ 1:8 and ≥ 1:128 | ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1). | Posted | | Count of Participants | | Participants | | At month 0, month 1 and month 2 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 |
|
| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | The results were tabulated as geometric mean expressed in titers. | ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1). | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At month 0, month 1 and month 2 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 | Meningitec Group |
|
| Secondary | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off | The cut-off for the assay were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL, respectively. | ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1). | Posted | | Count of Participants | | Participants | | At month 0, month 1 and month 2 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 |
|
| Secondary | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | The results for the assay were tabulated as geometric mean expressed in microgram per milliliter (μg/mL). | ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1). | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At month 0, month 1 and month 2 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 |
|
| Secondary | Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT) | The cut-off for the assay was ≥ 0.1 | ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1). | Posted | | Count of Participants | | Participants | | At month 0, month 1 and month 2 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 | Meningitec Group |
|
| Secondary | Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations | The results for the assay were tabulated as geometric mean expressed in internationl units per milliliter (IU/mL). | ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1). | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At month 0, month 1 and month 2 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 |
|
| Secondary | Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off | The cut-off for the assay was ≥ 0.1 | ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1). | Posted | | Count of Participants | | Participants | | At month 0, month 1 and month 2 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 | Meningitec Group |
|
| Secondary | Anti-diphtheria (Anti-D) Antibody Concentrations | The results for the assay were tabulated as geometric mean expressed in internationl units per milliliter (IU/mL). | ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1). | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At month 0, month 1 and month 2 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 |
|
| Secondary | Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off | The cut-off for the assay was ≥ 1:8. | ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1). | Posted | | Count of Participants | | Participants | | At month 0, month 1 and month 2 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 | Meningitec Group |
|
| Secondary | Anti-polio Type 1, 2 & 3 Titers | The results for the assay were tabulated as geometric mean expressed in titers. | ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1). | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At month 0, 1 and 2 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 | Meningitec Group |
|
| Secondary | Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off | The cut-off for the assay was ≥ 1.0 | ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1). | Posted | | Count of Participants | | Participants | | At month 0, month 1 and month 2 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 | Meningitec Group |
|
| Secondary | Anti-PRP Antibody Concentrations | The results for the assay were tabulated as geometric mean expressed in microgram per milliliter (μg/mL). | ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1). | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At month 0, month 1 and month 2 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 | Meningitec Group |
|
| Secondary | Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs | The cut-offs for the assay were ≥ 10 mIU/mL and ≥ 100 mIU/mL respectively . | ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1). | Posted | | Count of Participants | | Participants | | At month 0, month 1 and month 2 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 | Meningitec Group |
|
| Secondary | Anti-HBs Antibody Concentrations | The results for the assay were tabulated as geometric mean expressed in milli-international units per milliliter (mIU/mL). | ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1). | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At month 0, month 1 and month 2 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 |
|
| Secondary | Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens | Vaccine response to these antigens is defined as appearance of antibodies in subjects who were seronegative (antibody concentration < 5 EL.U/mL) at pre-vaccination or as at least a 2-fold increase in post-over pre-vaccination antibody concentrations in subjects seropositive at pre-vaccination. The analysis was based only on subjects receiving experimental vaccination. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component prior to (M0) and after vaccination (M1). | Posted | | Count of Participants | | Participants | | 1 month after vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. |
|
| Secondary | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | The results were tabulated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1). | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At month 0, month 1 and month 2 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 |
|
| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom irrespective of intensity grade. Grade 3 Pain was defined as crying when limb was moved/ spontaneously painful. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in after meningococcal vaccination. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) follow-up period after Nimenrix or Meningitec vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | |
|
| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination | The analysis was based only on subjects receiving combined-diphtheria vaccination. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in after the Infanrix-hexa vaccination. Subjects in the Meningitec Group did not receive any Infanrix-hexa and hence are not included in this analysis. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) follow-up period after Infanrix-hexa vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. |
| |
| Secondary | Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose | Solicited general symptoms assessed were drowsiness, fever, irritability and loss of appetite. Any was defined as occurrence of any general symptom irrespective of intensity grade and relationship. Subjects in the Nimenrix + Infanrix-hexa Group did not receive a second dose of vaccination. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-vaccination dose 1 (D1) and second dose (D2) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | |
|
| Secondary | Number of Subjects Reporting Any Rash | Any was defined as occurrence of at least one symptom experienced. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | Day 0 - Month 7 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 | Meningitec Group | Subjects received 1 dose of Meningitecâ„¢ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed. |
|
| Secondary | Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs) | Any was defined as occurrence of at least one symptom experienced. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | Day 0 - Month 7 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 | Meningitec Group | Subjects received 1 dose of Meningitecâ„¢ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed. |
|
| Secondary | Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits (ER) | Any was defined as occurrence of at least one symptom experienced. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in. | Posted | | Count of Participants | | Participants | | Day 0 - Month 7 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 | Meningitec Group | Subjects received 1 dose of Meningitecâ„¢ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed. |
|
| Secondary | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First Dose | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | Occurring within Day 0-30 following vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 |
|
| Secondary | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the Second Dose | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. The analysis was based only on subjects receiving a second dose of vaccination. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in. | Posted | | Count of Participants | | Participants | | Occurring within Day 0-30 following vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG001 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. |
| |
| Secondary | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | From dose 1 (Month 0) up to study end (Month 7) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Infanrix-hexa Group | Subjects received concomitant administration of 1 dose of Nimenrixâ„¢ and Infanrix-hexaâ„¢ vaccines at Day 0. | | OG001 | Nimenrix Group | Subjects received a single dose of Nimenrixâ„¢ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexaâ„¢ vaccine. | | OG002 | Infanrix-Hexa Group | Subjects received a single dose of Infanrix-Hexaâ„¢ vaccine at Day 0, followed one month later by 1 dose of Nimenrixâ„¢ vaccine. | | OG003 | Meningitec Group | |
|