| Primary | Percentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value. | The cut-off value for the rSBA-MenA, rSBA-MenW-135 and rSBA-Y titers was greater than or equal to (≥) 1:8. Indication of the immunogenicity of the 2-dose and 3-dose schedules: the lower limit of the two-sided exact 95% CI for the percentage of subjects with post-primary vaccination rSBA antibody titre ≥ 1:8 is greater than or equal to the pre-defined clinical limit of 80%. | The analysis was performed on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all subjects who complied with the protocol, who were administered a vaccine containing rSBA-MenA, rSBA-MenW-135 and rSBA-Y components (i.e. only Group Nimenrix 3 and Nimenrix 2) and with available data for the considered assay and time point. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | One month after the final primary vaccination at Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
| | | Title | Denominators | Categories |
|---|
| rSBA-MenA | - ParticipantsOG000462
- ParticipantsOG001456
| |
| |
| Primary | Number of Subjects With rSBA-MenC Antibody Titers ≥ the Cut-off Value | The cut-off value for rSBA-MenC titers was ≥ 1:8. | The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2)and with the blood sample schedule for Visit 4 (Month 3). | Posted | | Count of Participants | | Participants | | One month after the final primary vaccination at Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. | | OG002 | Menjugate Group |
|
| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values | The cut-off values for rSBA-Men antibody titers were greater than or equal to (≥) 1:8 and ≥ 1:128 at pre-vaccination | The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for a randomized subset of 50% subjects for each of the 4 serogroups in the investigational groups, and in a randomized subset of 50% and 25% subjects for MenC, MenA, MenW, MenY in control groups. | Posted | | Count of Participants | | Participants | | Pre-primary vaccination at Month 0 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for a randomized subset of 50% subjects for each of the 4 serogroups in the investigational groups, and in a randomized subset of 50% and 25% subjects for MenC, MenA, MenW, MenY in control groups. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Pre-primary vaccination at Month 0 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. | |
|
| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values | The cut-off values for the rSBA-Men antibody titers were greater than or equal to (≥) 1:8 and ≥ 1:128. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11). | Posted | | Count of Participants | | Participants | | Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. | |
|
| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11). | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. | | OG002 |
|
| Secondary | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values | The cut-off values for hSBA antibody titers were greater than or equal to (≥) 1:4 and ≥ 1:8. | The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who used hSBA complement and who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3). | Posted | | Count of Participants | | Participants | | Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who used hSBA complement and who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3). | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. | |
|
| Secondary | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values | The cut-off values for hSBA antibody titers were greater than or equal to (≥) 1:4 and ≥ 1:8. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who used hSBA complement and who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11). | Posted | | Count of Participants | | Participants | | Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who used hSBA complement and who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11). | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. | | OG002 |
|
| Secondary | Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values | The cut-off values for anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F concentrations were greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL) and ≥ 0.35 µg/mL | The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects. | Posted | | Count of Participants | | Participants | | Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Anti-pneumococcal Serotypes Antibody Concentrations | Anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in µg/mL. | The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values | The cut-off values for anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F concentrations were ≥ 0.15 µg/mL and ≥ 0.35 µg/mL | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects. | Posted | | Count of Participants | | Participants | | Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Anti-pneumococcal Serotypes Antibody Concentrations | Anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in µg/mL. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off Value | The cut-off value for anti-D and anti-T concentrations was greater than or equal to (≥) 0.1 IU/mL | The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects. | Posted | | Count of Participants | | Participants | | Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). | The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value | The cut-off value for anti-D and anti-T concentrations was greater than or equal to (≥) 0.1 IU/mL | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects. | Posted | | Count of Participants | | Participants | | Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off Value | The cut-off value for anti-PT, anti-FHA and anti-PRN concentrations was greater than or equal to (≥) 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects. | Posted | | Count of Participants | | Participants | | Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in EL.U/mL. | The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off Value | The cut-off value for anti-PT, anti-FHA and anti-PRN concentrations was greater than or equal to (≥) 5 EL.U/mL. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects. | Posted | | Count of Participants | | Participants | | Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in EL.U/mL. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Values | The cut-off values for anti-HBs concentrations were greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL) and ≥ 100 mIU/mL. | The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects. | Posted | | Count of Participants | | Participants | | Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Anti-HBs Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). | The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Values | The cut-off values for anti-HBs concentrations were greater than or equal to (≥) 10 mIU/mL and ≥ 100 mIU/mL. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects. | Posted | | Count of Participants | | Participants | | Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Anti-HBs Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off Values | The cut-off values for anti-PRP antibody concentrations were greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL) and ≥ 1.0 µg/mL. | The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects. | Posted | | Count of Participants | | Participants | | Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Anti-PRP Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). | The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off Values | The cut-off values for anti-PRP antibody concentrations were greater than or equal to (≥) 0.15 µg/mL and ≥ 1.0 µg/mL. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects. | Posted | | Count of Participants | | Participants | | Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Anti-PRP Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Number of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value | The cut-off value for anti-poliovirus type 1, 2 and 3 antibody concentrations was greater than or equal to (≥) 1:8. | The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects. | Posted | | Count of Participants | | Participants | | Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Anti-polio Type 1, 2 and 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. | |
|
| Secondary | Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value | The cut-off value for anti-poliovirus type 1, 2 and 3 antibody concentrations was greater than or equal to (≥) 1:8. | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects. | Posted | | Count of Participants | | Participants | | Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Anti-polio Type 1, 2 and 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. | | OG002 |
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. For the Nimenrix 2, Menjugate and NeisVac-C groups, results corresponding to Dose 2 are for Infanrix hexa and Synflorix vaccination at Visit 2 (Month 1), while results corresponding to Dose 3 refer to the vaccination at Visit 3 (Month 2). | The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. For the considered assay and time point data was reported only for the Primary Vaccination doses. | Posted | | Count of Participants | | Participants | | During the 8-day (Days 0-7) post-vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | |
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. | The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. No data was applicable for the Nimenrix 2 Group, Menjugate Group and NeisVac-C Group since meningococcal vaccine was not given in Dose 2. | Posted | | Count of Participants | | Participants | | During the 8-day (Days 0-7) post-meningococcal vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrixâ„¢ Hexa Vaccination | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. | The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. For the considered assay and time point data was reported only for the Primary Vaccination doses. | Posted | | Count of Participants | | Participants | | During the 8-day (Days 0-7) post-Infanrix hexa vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. | The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. For the considered assay and time point data was reported only for the primary vaccination doses. | Posted | | Count of Participants | | Participants | | During the 8-day (Days 0-7) post-Synflorix vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. | The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets. | Posted | | Count of Participants | | Participants | | During the 8-day (Days 0-7) post-meningococcal booster vaccination period | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrixâ„¢ Hexa Vaccination | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. | The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets. | Posted | | Count of Participants | | Participants | | During the 8-day (Days 0-7) post-Infanrixâ„¢ hexa booster vaccination period | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
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| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. | Posted | | Count of Participants | | Participants | | Within 31-days (Days 0-30) post-each primary vaccination dose | | | | ID | Title | Description |
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| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorixâ„¢ Vaccination | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. | The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets. | Posted | | Count of Participants | | Participants | | During the 8-day (Days 0-7) post-Synflorixâ„¢ booster vaccination period | | | | ID | Title | Description |
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| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as rectal temperature greater than or equal to (≥) 38 degrees Celsius (°C)]. Any = occurrence of any general symptoms, regardless of their intensity grade or relationship to study vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Not eating at all. Grade 3 Temperature= temperature above 40.0 (°C). Related = symptom assessed by the investigator as related to the vaccination. For the Nimenrix 2, Menjugate and NeisVac-C groups, results corresponding to Dose 2 are for Infanrix™ hexa and Synflorix™ vaccination at Visit 2 (Month 1), while results corresponding to Dose 3 refer to the vaccination at Visit 3 (Month 2). | The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. | Posted | | Count of Participants | | Participants | | During the 8-day (Days 0-7) post-vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination) | | | | ID | Title | Description |
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| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as rectal temperature greater than or equal to (≥) 38 degrees Celsius (°C)]. Any = occurrence of any general symptoms, regardless of their intensity grade or relationship to study vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Not eating at all. Grade 3 Temperature= temperature above 40.0 (°C). Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets. | Posted | | Count of Participants | | Participants | | During the 8-day (Days 0-7) post-booster vaccination period | | | | ID | Title | Description |
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| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
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| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets. | Posted | | Count of Participants | | Participants | | Within 31-days (Days 0-30) post-booster vaccination period | | | | ID | Title | Description |
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| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. | Posted | | Count of Participants | | Participants | | Throughout the entire study (from Day 0 to Month 16) | | | | ID | Title | Description |
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| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. | | OG002 |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets. | Posted | | Count of Participants | | Participants | | From Booster vaccination (Month 10) up to Extended Safety Follow-Up (ESFU) (Month 16) | | | | ID | Title | Description |
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| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. | |
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| Secondary | Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | NOCIs assessed included asthma, autoimmune disorders, type 1 diabetes and allergies. | The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. | Posted | | Count of Participants | | Participants | | During 31-days (Days 0-30) post-each primary vaccination dose (Day 0 to Month 3) and from primary vaccination up to ESFU (Month 16) | | | | ID | Title | Description |
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| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. | | OG002 |
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| Secondary | Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | NOCIs assessed included asthma, autoimmune disorders, type 1 diabetes and allergies. | The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets. | Posted | | Count of Participants | | Participants | | From Booster vaccination (Month 10 to Month 11) up to ESFU (Month 16) | | | | ID | Title | Description |
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| OG000 | Nimenrix 3 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrixâ„¢ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 3, 4 and 12 months of age. | | OG001 | Nimenrix 2 Group | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrixâ„¢ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrixâ„¢ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrixâ„¢ hexa and Synflorixâ„¢ vaccines at 2, 4 and 12 months of age. | | OG002 | Menjugate Group |
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