| Primary | Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values | The cut-off values for the rSBA titers were ≥ 1:8. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | 42 days after the first vaccine dose (Day 42) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 | Meningitec Group | Subjects received 1 dose of Meningitecâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. |
| | | Title | Denominators | Categories |
|---|
| rSBA-MenA, D42 | - ParticipantsOG000360
- ParticipantsOG001354
- ParticipantsOG00251
| |
| | 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 |
|---|
| | | | | | Difference in percentage | 2.2 | | | 2-Sided | 95 | 0.29 | 6.78 | | | | | Non-Inferiority | Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥-10%. | | | | |
|
| Primary | Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values | The cut-off values for anti-measles antibody concentrations were ≥ 150 milli-international units per milliliter (mIU/mL). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | 42 days after the first vaccine dose (Day 42) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 | Priorix-Tetra Group | Subjects received 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0, 1 dose of Meningitecâ„¢ vaccine on Day 42 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. |
|
| Primary | Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values | The cut-off values for anti-mumps antibody concentrations were ≥ 231 units per milliliter (U/mL). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | 42 days after the first vaccine dose (Day 42) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 | Priorix-Tetra Group | Subjects received 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0, 1 dose of Meningitecâ„¢ vaccine on Day 42 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. |
|
| Primary | Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values. | The cut-off values for anti-rubella antibody concentrations were ≥ 4 international units per milliliter (IU/mL). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | 42 days after the first vaccine dose (Day 42) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 | Priorix-Tetra Group | Subjects received 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0, 1 dose of Meningitecâ„¢ vaccine on Day 42 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. |
|
| Primary | Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values | The cut-off values for anti-varicella antibody concentrations were ≥ 1:4. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | 42 days after the first vaccine dose (Day 42) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 | Priorix-Tetra Group | Subjects received 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0, 1 dose of Meningitecâ„¢ vaccine on Day 42 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | |
|
| 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 rSBA titers were ≥ 1:8 and ≥ 1:128 respectively. At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half was tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | Prior to vaccination (Day 0) and after the first vaccination dose (Day 42) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. |
|
| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | Antibody titers were expressed as geometric mean titers (GMTs). At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. |
|
| Secondary | Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values | Anti-PS antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as microgram per milliliter (μg/mL). At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 | Priorix-Tetra Group |
|
| Secondary | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values | The cut-off values for anti-PS antibody concentrations were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL respectively. At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 | Priorix-Tetra Group | |
|
| Secondary | Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | The cut-off values for hSBA antibody titers were ≥ 1:4 and ≥ 1:8 for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Count of Participants | | Participants | | Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 |
|
| Secondary | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | Anti-hSBA antibody titers were expressed as geometric mean titers (GMTs) for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 | Meningitec Group | |
|
| Secondary | Anti-measles Antibody Concentrations | Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) in all groups. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | 42 days after the first vaccine dose (Day 42) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 | Priorix-Tetra Group | Subjects received 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0, 1 dose of Meningitecâ„¢ vaccine on Day 42 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. |
|
| Secondary | Anti-measles Antibody Concentrations | Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in mIU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | 42 days after the second Priorix-Tetra vaccine dose (Day 126) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Priorix-Tetra Group | Subjects received 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0, 1 dose of Meningitecâ„¢ vaccine on Day 42 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. |
| |
| Secondary | Anti-mumps Antibody Concentrations | Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in units per milliliter (U/mL) in all groups. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | U/mL | | 42 days after the first vaccine dose (Day 42) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 | Priorix-Tetra Group | Subjects received 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0, 1 dose of Meningitecâ„¢ vaccine on Day 42 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. |
|
| Secondary | Anti-mumps Antibody Concentrations | Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in U/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | U/mL | | 42 days after the second Priorix-Tetra vaccine dose (Day 126) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Priorix-Tetra Group | Subjects received 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0, 1 dose of Meningitecâ„¢ vaccine on Day 42 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. |
| |
| Secondary | Anti-rubella Antibody Concentrations | Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in international units per millilier (IU/mL) in all groups. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | 42 days after the first vaccine dose (Day 42) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 | Priorix-Tetra Group | Subjects received 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0, 1 dose of Meningitecâ„¢ vaccine on Day 42 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. |
|
| Secondary | Anti-rubella Antibody Concentrations | Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in IU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | 42 days after the second Priorix-Tetra vaccine dose (Day 126) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Priorix-Tetra Group | Subjects received 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0, 1 dose of Meningitecâ„¢ vaccine on Day 42 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. |
| |
| Secondary | Anti-varicella Antibody Titers | Anti-varicella antibody titers were given as geometric mean titers (GMTs) for all groups. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 42 days after the first vaccine dose (Day 42) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 | Priorix-Tetra Group | Subjects received 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0, 1 dose of Meningitecâ„¢ vaccine on Day 42 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | |
|
| Secondary | Anti-varicella Antibody Titers | Anti-varicella antibody titers were given as geometric mean titers (GMTs) in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 42 days after the second Priorix-Tetra vaccine dose (Day 126) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Priorix-Tetra Group | Subjects received 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0, 1 dose of Meningitecâ„¢ vaccine on Day 42 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. |
| |
| Secondary | Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination | Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group and Priorix-Tetra Group, respectively. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0. | 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) after vaccination with first dose of Priorix-Tetra vaccine at Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Priorix-Tetra Group | Subjects received 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0, 1 dose of Meningitecâ„¢ vaccine on Day 42 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. |
| |
| Secondary | Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0 | Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group, Nimenrix Group and Meningitec Group, respectively. The analysis was performed only on subjects receiving meningitis vaccination (Priorix-Tetra) at Day 0. | 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) after vaccination with Nimenrix or Meningitec at Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 | Meningitec Group | Subjects received 1 dose of Meningitecâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. |
|
| Secondary | Number of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed were drowsiness, fever (measured rectally and temperature ≥ 38.0°C ), irritability and loss of appetite, Meningismus, Parotiditis and Rash. | 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) follow-up period after first vaccination dose in all groups | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 | Priorix-Tetra Group | Subjects received 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0, 1 dose of Meningitecâ„¢ vaccine on Day 42 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG003 |
|
| Secondary | Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms | Solicited general symptoms assessed were fever (measured rectally and temperature ≥ 38.0°C ), Meningismus, Parotiditis and Rash. | 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 43-day (Days 0-42) after first vaccination dose | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 | Priorix-Tetra Group | Subjects received 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0, 1 dose of Meningitecâ„¢ vaccine on Day 42 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG003 | Meningitec Group |
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| Secondary | Number of Subjects Reporting Specific Adverse Events (AEs) | Specific AEs include: rash, New Onset of Chronic Illness(es) (NOCI), and/or conditions prompting emergency room (ER) visits or non-routine physician office visits. | The analysis was performed on the Total Vaccinated Cohort (TVC ), which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | From Day 0 up to Month 6 after first vaccine dose | | | | ID | Title | Description |
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| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 | Priorix-Tetra Group | Subjects received 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0, 1 dose of Meningitecâ„¢ vaccine on Day 42 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG003 | Meningitec Group |
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| Secondary | Number of Subjects Reporting Unsolicited Symptoms | Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | During the 43-day (Days 0-42) post Dose 1 vaccination period | | | | ID | Title | Description |
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| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 | Priorix-Tetra Group | Subjects received 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0, 1 dose of Meningitecâ„¢ vaccine on Day 42 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG003 | Meningitec Group |
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| Secondary | Number of Subjects Reporting Unsolicited Symptoms | Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | During the 43-day (Days 0-42) follow-up period after each vaccination | | | | ID | Title | Description |
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| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 | Priorix-Tetra Group | Subjects received 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0, 1 dose of Meningitecâ„¢ vaccine on Day 42 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG003 | Meningitec Group |
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/ incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | From Day 0 up to Month 6 after vaccination | | | | ID | Title | Description |
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| OG000 | Nimenrix + Priorix-Tetra Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine and 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG001 | Nimenrix Group | Subjects received 1 dose of Nimenrixâ„¢ vaccine on Day 0 followed by 2 doses of Priorix-Tetraâ„¢ vaccine, respectively 42 and 84 days later. | | OG002 | Priorix-Tetra Group | Subjects received 1 dose of Priorix-Tetraâ„¢ vaccine on Day 0, 1 dose of Meningitecâ„¢ vaccine on Day 42 and a second dose of Priorix-Tetraâ„¢ vaccine on Day 84. | | OG003 |
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