| Primary | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Against Neisseria Meningitidis Serogroups Antibody Titers Greater Than or Equal to (≥) 1:8, One Month Post Dose 3 for the Nimenrix 3+1 Group | The cut-off value for the rSBA titers was ≥ 1:8. Neisseria meningitidis serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) antibodies were assessed. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects, who complied with the vaccination schedule and for whom data concerning immunogenicity endpoint measures were available. This endpoint was specified to be analysed for the Nimenrix 3+1 Group only. | Posted | | Count of Participants | | Participants | | At Month 5 (one month post-dose 3) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
| | | Title | Denominators | Categories |
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| rSBA-MenA | | | | rSBA-MenC | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup A one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants | | | | | Percentage of subjects | 100 | | | 2-Sided | 95 | 98.9 | 100 | | | Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%. | | Superiority or Other | |
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| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:8 Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group | The cut-off value for the rSBA titers was ≥ 1:8 | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects, who complied with the vaccination schedule and for whom data concerning immunogenicity endpoint measures were available. | Posted | | Count of Participants | | Participants | | At Month 13 (prior booster) and at Month 14 (one month after the booster dose) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
| |
| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:128, One Month Post-dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group | The cut-off value for the rSBA titers was ≥ 1:128 | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects, who complied with the vaccination schedule and for whom data concerning immunogenicity endpoint measures were available. | Posted | | Count of Participants | | Participants | | At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
| |
| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers One Month Post Dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group | Antibody titers are presented as geometric mean titers (GMTs). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects, who complied with the vaccination schedule and for whom data concerning immunogenicity endpoint measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
| |
| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups | The cut-off values for the rSBA antibody titers were ≥ 1:8 and ≥ 1:128 | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects, who complied with the vaccination schedule and for whom data concerning immunogenicity endpoint measures were available. | Posted | | Count of Participants | | Participants | | At Months 5 (one month post-primary dose for Nimenrix 1+1 Group), 13 (prior booster dose for Nimenrix 1+1 and prior primary dose for Nimenrix Control Group) and 14 (post booster dose for Nimenrix 1+1 and post-primary dose for Nimenrix Control Group) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix Control Group | Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers for Nimenrix 1+1 and Nimenrix Control Groups | Antibody titers are presented as geometric mean titers (GMTs). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects, who complied with the vaccination schedule and for whom data concerning immunogenicity endpoint measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Months 5 (one month post-primary dose for Nimenrix 1+1 Group), 13 (prior booster dose for Nimenrix 1+1 and prior primary dose for Nimenrix Control Group) and 14 (post booster dose Nimenrix 1+1 and post-primary dose for Nimenrix Control Group) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix Control Group | Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | Number of Subjects With Booster Responses for rSBA-MenA, C rSBA-MenC, Y rSBA-MenY and W-135 rSBA-MenW-135 in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group | Vaccine/Booster response was defined as: for seronegative subjects (rSBA titers < 1:8 pre-vaccination at Month 13), antibody titer ≥ 1:32 at post vaccination; for seropositive subjects (rSBA titers >= 1:8 pre-vaccination at Month 13), antibody titer at post vaccination ≥ 4-fold the pre vaccination antibody titer. | The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects, who complied with the vaccination schedule at Month 13 (booster dose for Nimenrix 3+1 and Nimenrix 1+1 and first dose in Nimenrix Control) and for whom data concerning immunogenicity endpoint measures were available | Posted | | Count of Participants | | Participants | | At Month 14 (one month post-booster dose for Nimenrix 3+1 and Nimenrix 1+1 and post-primary dose for Nimenrix Control Group) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | |
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| Secondary | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y Antibody Titers Greater Than or Equal to (≥) the Cut-off Values (One Month Post-primary for Nimenrix 3+1 and 1+1 Groups) | The cut-off value for the hSBA titers was ≥ 1:4 and ≥ 1:8. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 50% of subjects from each group. | Posted | | Count of Participants | | Participants | | At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
|
| Secondary | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (One Month Post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)) -Randomized Subset of 50% of Subjects of All Three Groups | Antibody titers are presented as geometric mean titers (GMTs). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 50% of subjects from each group. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control) | The cut-off value for the hSBA titers was ≥ 1:4 and ≥ 1:8. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 75% of subjects from each group. | Posted | | Count of Participants | | Participants | | At Month 13 (pre-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and pre-vaccination for Nimenrix Control), and at Month 14 (post-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and post-vaccination for Nimenrix Control) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (Pre-booster for Nimenrix 3+1 and 1+1 Groups and Pre-vaccination for Nimenrix Control, and Post-booster for Nimenrix 3+1 and 1+1 Groups and Post-vaccination for Nimenrix Control) | Antibody titers are presented as geometric mean titers (GMTs). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 75% of subjects from each group. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 13 (pre-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and pre-vaccination for Nimenrix Control), and at Month 14 (post-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and post-vaccination for Nimenrix Control) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | Number of Subjects With Booster Responses for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group | Vaccine/Booster response was defined as: for seronegative subjects (rSBA titers < 1:4 pre-vaccination at Month 13), antibody titer ≥ 1:32 at post vaccination; for seropositive subjects (rSBA titers >= 1:4 pre-vaccination at Month 13), antibody titer at post vaccination ≥ 4-fold the pre vaccination. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 75% of subjects from each group. | Posted | | Count of Participants | | Participants | | At Month 14 (one month after the booster dose in Nimenrix 3+1 and Nimenrix 1+1 and post-vaccination in Nimenrix Control Group) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). | The anti-pneumococcal serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 25% of all subjects. | Posted | | Count of Participants | | Participants | | At Months 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) | The anti-pneumococcal serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 25% of all subjects. | Posted | | Count of Participants | | Participants | | At Months 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | Anti-pneumococcal Antibody Concentrations | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (µg/mL) | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 25% of all subjects. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | Number of Subjects With Anti-diphtheria (Anti-D) Antibodies | Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). | The analysis was performed on a randomized subset of 25% in the primary ATP cohort for immunogenicity who complied with the protocol criteria and for whom data concerning immunogenicity endpoint measures were available, for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination. | Posted | | Count of Participants | | Participants | | At Month 5 (one month post-dose 3) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG002 |
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| Secondary | Concentration of Antibodies Against Diphtheria Antigens (Anti-D) | Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL). | The analysis was performed on a randomized subset of 25% in the primary ATP cohort for immunogenicity who complied with the protocol criteria and for whom data concerning immunogenicity endpoint measures were available, for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Month 5 (one month post-dose 3) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | |
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| Secondary | Concentration of Antibodies Against Diphtheria Antigens (Anti-D) | Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL). The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis. | The analysis was performed on the Primary TVC, which included all vaccinated subjects during the primary phase. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Month 5 (one month post-dose 3) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | Concentration of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) Antigens | Concentrations are presented as geometric mean concentrations (GMCs) expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml). | The analysis was performed on a randomized subset of 25% in the primary ATP cohort for immunogenicity who complied with the protocol criteria and for whom data concerning immunogenicity endpoint measures were available, for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Month 5 (one month post-dose 3) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Immunoglobulin G (IgG) Antibodies | Cut-off values assessed were greater than or equal to ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml). | The analysis was performed on the Primary TVC included all vaccinated subjects during the primary phase. | Posted | | Count of Participants | | Participants | | At Month 5 (one month post-dose 3) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG002 | Nimenrix Control Group |
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| Secondary | Concentration of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) Antigens | Concentrations are presented as geometric mean concentrations (GMCs) expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml). | The analysis was performed on the Primary TVC, which included all vaccinated subjects during the primary phase. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Month 5 (one month post-dose 3) | | | | ID | Title | Description |
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| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG002 | Nimenrix Control Group |
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| Secondary | Antibody Titers for Anti-polio Type 1, 2 and 3 Antibodies | Antibody titers are presented as geometric mean titers (GMTs). | The analysis was performed on a randomized subset of 25% in the primary ATP cohort for immunogenicity who complied with the protocol criteria and for whom data concerning immunogenicity endpoint measures were available, for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 5 (one month post-dose 3) | | | | ID | Title | Description |
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| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG002 |
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| Secondary | Antibody Titers for Anti-polio Type 1, 2 and 3 Antibodies | Antibody titers are presented as geometric mean titers (GMTs). The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis. | The analysis was performed on the Primary TVC, which included all vaccinated subjects during the primary phase. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 5 (one month post-dose 3) | | | | ID | Title | Description |
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| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | Number of Subjects With Anti-tetanus (Anti-T) Antibodies | Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). | The analysis was performed on the ATP cohort for immunogenicity adapted for each timepoint, which included all eligible subjects, who complied with the vaccination schedule and for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 25% of subjects of all three groups. | Posted | | Count of Participants | | Participants | | At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose) | | | | ID | Title | Description |
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| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | Concentration of Antibodies Against Tetanus Antigens (Anti-T) | Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL). | The analysis was performed on the ATP cohort for immunogenicity adapted for each timepoint, which included all eligible subjects, who complied with the vaccination schedule and for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 25% of subjects of all three groups. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | Number of Subjects With Anti-tetanus (Anti-T) Antibodies | Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis. | The analysis was performed on the Adapted TVC, which included all vaccinated subjects during the primary phase. | Posted | | Count of Participants | | Participants | | At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose) | | | | ID | Title | Description |
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| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | Anti-PRP Antibody Concentrations (Geometric Mean Concentrations) in a Randomized Subset of 25% of the Subjects | The endpoints evaluating immunogenicity of the Hib component (anti-polyribosyl ribitol phosphate [anti-PRP] antibody concentrations) has been cancelled owing to the extended delay in the re-development and re-validation of the PRP assay. | No subjects were analyzed because the endpoints evaluating immunogenicity of the Hib component (anti-polyribosyl ribitol phosphate [anti-PRP] antibody concentrations) has been cancelled owing to the extended delay in the re-development and re-validation of the PRP assay. | Posted | | | | | | At Month 5 (one month post-dose 3) | | | | ID | Title | Description |
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| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | Number of Subjects With Solicited Local Symptoms (Primary Phase) | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. 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 their symptom sheets completed. | Posted | | Count of Participants | | Participants | | Within 8 days (Day 0-7) post primary vaccination | | | | ID | Title | Description |
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| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | |
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| Secondary | Number of Subjects With Solicited Local Symptoms (Booster Phase) | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. 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 at booster time point (at Month 13) who had their symptom sheets completed. | Posted | | Count of Participants | | Participants | | Within 8 days (Day 0-7) post booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | |
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| Secondary | Number of Subjects With Solicited General Symptoms (Primary Phase) | Assessed solicited general symptoms were temperature [defined as rectally temperature equal to or above 38 degrees Celsius (°C)], drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase who had their symptom sheets completed. | Posted | | Count of Participants | | Participants | | Within 8 days (Day 0-7) post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | Number of Subjects With Solicited General Symptoms (Booster Phase) | Assessed solicited general symptoms were temperature [defined as rectally temperature equal to or above 38 degrees Celsius (°C)], drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature > 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 at booster time point (at Month 13) who had their symptom sheets completed. | Posted | | Count of Participants | | Participants | | Within 8 days (Day 0-7) post booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) (Primary Phase) | 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. | Posted | | Count of Participants | | Participants | | Within 31 days (Day 0-30) post each primary vaccine dose | | | | ID | Title | Description |
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| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) (Booster Phase) | 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 at booster time point (at Month 13). | Posted | | Count of Participants | | Participants | | Within 31 days (Day 0-30) post booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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| Secondary | Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase. | Posted | | Count of Participants | | Participants | | From Day 0 to Month 19 | | | | ID | Title | Description |
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| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG002 | Nimenrix Control Group | Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
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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. | Posted | | Count of Participants | | Participants | | From Day 0 to Month 19 | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 3+1 Group | Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG001 | Nimenrix 1+1 Group | Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. | | OG002 | Nimenrix Control Group | |
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