| Primary | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off | hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was greater than or equal to ( ≥) 1:8. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Count of Participants | | Participants | | At Year 1 (12 months post primary vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y1 | Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y1 | Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
| | | Title | Denominators | Categories |
|---|
| hSBA-MenA, ≥ 1:8 | - ParticipantsOG000102
- ParticipantsOG001108
| |
| |
| Primary | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off | hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Count of Participants | | Participants | | At Year 3 (36 months post primnary vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y3 | Subjects from Year 3 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y3 | Subjects from Year 3 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
| |
| Primary | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values | hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Count of Participants | | Participants | | At Year 5 (60 months post primary vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y5 | Subjects from Year 5 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y5 | Subjects from Year 5 period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
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| Secondary | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Count of Participants | | Participants | | At Year 1 (12 months post vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y1 | Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y1 | Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
| |
| Secondary | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Count of Participants | | Participants | | At Year 3 (36 months post primary vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y3 | Subjects from Year 3 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y3 | Subjects from Year 3 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
| |
| Secondary | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Count of Participants | | Participants | | At Year 5 (60 months post primary vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y5 | Subjects from Year 5 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y5 | Subjects from Year 5 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
| |
| Secondary | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Geometric Mean | 95% Confidence Interval | Titres | | At Year 1 (12 months post primary vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y1 | Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y1 | Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
| |
| Secondary | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Geometric Mean | 95% Confidence Interval | Titres | | At Year 3 (36 months post primary vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y3 | Subjects from Year 3 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y3 | Subjects from Year 3 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
| |
| Secondary | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Geometric Mean | 95% Confidence Interval | Titres | | At Year 5 (60 months post primary vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y5 | Subjects from Year 5 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y5 | Subjects from Year 5 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
| |
| Secondary | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Count of Participants | | Participants | | At Year 1 (12 months post primary vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y1 | Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y1 | Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
| |
| Secondary | Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement | rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Count of Participants | | Participants | | At Year 3 (36 months post primary vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y3 | Subjects from Year 3 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y3 | Subjects from Year 3 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
| |
| Secondary | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128. Titers were determined by Public Health England (PHE) laboratory assay. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Count of Participants | | Participants | | At Year 3 (36 months post primary vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y3 | Subjects from Year 3 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y3 | Subjects from Year 3 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
| |
| Secondary | Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Count of Participants | | Participants | | At Year 5 (60 months post-primary vacccination). | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y5 | Subjects from Year 5 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y5 | Subjects from Year 5 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
| |
| Secondary | Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128 determined by Public Health England (PHE) laboratory assay. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Count of Participants | | Participants | | At Year 5 (60 months post-primary vacccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y5 | Subjects from Year 5 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y5 | Subjects from Year 5 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
| |
| Secondary | rSBA Antibody Titers | Titers were given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, as performed by GSK Biologicals' laboratory assay. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Year 1 (12 months post primary vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y1 | Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y1 | Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
| |
| Secondary | rSBA Antibody Titers. | Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, as performed by GSK Biologicals' laboratory assay. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Year 3 (36 months post-primary vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y3 | Subjects from Year 3 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y3 | Subjects from Year 3 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
| |
| Secondary | rSBA Antibody Titers | Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY respectively. Titers were determined by Public Health England (PHE) laboratory assay. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Year 3 (36 months following primary vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y3 | Subjects who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y3 | Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
| |
| Secondary | rSBA Antibody Titers | Titers are given as geometric mean titers (GMTs), calculated on all subjects for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively by GSK Biologicals' laboratory assay. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Year 5 (60 months post-primary vacccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y5 | Subjects from Year 5 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y5 | Subjects from Year 5 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
| |
| Secondary | rSBA Antibody Titers. | Titers are given as geometric mean titers (GMTs), calculated for all subjects for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively. Titers were determined by Public Health England (PHE) laboratory assay. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Year 5 (60 months following primary vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y5 | Subjects from Year 5 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y5 | Subjects from Year 5 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
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| Secondary | Antibody to Polysacccharide N. Meningitidis Serogroup A, C, W-135 and Y (Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY) Antibody Concentrations | Results were tabulated as geometric mean antibody concentration (GMC) calculated on all subjects, expressed in microgram per milliliter (μg/ml). | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Geometric Mean | 95% Confidence Interval | μg/ml | | At Year 1 (12 months post primary vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y1 | Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y1 | Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
| |
| Secondary | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values | The cut-off values for the assay were ≥ 0.3 μg/ml and ≥ 2.0 μg/ml respectively. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point. | Posted | | Count of Participants | | Participants | | At Year 1 (12 months post primary vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Group Y1 | Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | | OG001 | Nimenrix 2 Group Y1 | Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. |
| |
| Secondary | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:4 or 1:8. This outcome measure only concerns the Nimenrix Naive Group. | The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group. | Posted | | Count of Participants | | Participants | | At Month 60 (pre-primary vaccination with Nimenrix vaccine) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Naive Group | Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5. |
| |
| Secondary | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers | Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively. This outcome measure only concerns the Nimenrix Naive Group. | The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 60 (pre-vaccination with Nimenrix vaccine) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Naive Group | Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5. |
| |
| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values | rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 or 1:128. This outcome measure only concerns the Nimenrix Naive Group. | The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group. | Posted | | Count of Participants | | Participants | | At Month 60 (pre-primary vaccination with Nimenrix vaccine) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Naive Group | Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5. |
| |
| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively. This outcome measure only concerns the Nimenrix Naive Group. | The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 60 (pre-primary vaccination with Nimenrix vaccine) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Naive Group | Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5. |
| |
| Secondary | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:4 or 1:8. | The analysis was performed on the Booster ATP cohort for immunogenicity,which included all vaccinated subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix1 and Nimenrix 2 Group) | Posted | | Count of Participants | | Participants | | At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Booster Group Y5 | Subjects who received 1 dose on Nimenrix vaccine at 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG001 | Nimenrix 2 Booster Group Y5 | Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG002 | Nimenrix Naive Group Y5 |
|
| Secondary | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers | Titers were given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC,hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects. | The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group) | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Booster Group Y5 | Subjects who received 1 dose on Nimenrix vaccine at 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG001 | Nimenrix 2 Booster Group Y5 | Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG002 | Nimenrix Naive Group Y5 | |
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| Secondary | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | Vaccine response was defines as: for initially seronegative subjects (pre-vaccination titer < 1:4): hSBA post-vaccination antibody titers ≥ 1:8 and for seropositive subjects (pre-vaccination titers ≥ 1:4): hSBA antibody titers at least four times the pre-vaccination antibody titers. | The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group) | Posted | | Count of Participants | | Participants | | At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Booster Group Y5 | Subjects who received 1 dose on Nimenrix vaccine at 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG001 | Nimenrix 2 Booster Group Y5 | Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | |
|
| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | The cut-off values for the assay were ≥1:8 and ≥1:128. Titers were determined by Public Health England (PHE) laboratory assay. | The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group) | Posted | | Count of Participants | | Participants | | At Month 60 and 61 (just prior to and one month post-primary vaccination for Nimenrix Naive Group; one month post-booster vaccination for Nimenrix 1 and Nimenrix 2 Groups) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix 1 Booster Group Y5 | Subjects who received 1 dose on Nimenrix vaccine at 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG001 | Nimenrix 2 Booster Group Y5 | Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG002 | Nimenrix Naive Group Y5 |
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| Secondary | rSBA Antibody Titers | Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, determined by Public Health England [PHE] laboratory assay. | The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group) | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 60 and 61 (just prior to and one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups) | | | | ID | Title | Description |
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| OG000 | Nimenrix 1 Booster Group Y5 | Subjects who received 1 dose on Nimenrix vaccine at 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG001 | Nimenrix 2 Booster Group Y5 | Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG002 | Nimenrix Naive Group Y5 |
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| Secondary | Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers | Vaccine response was defined as: for initially seronegative subjects: antibody titer ≥ 1:32 at post-vaccination; and for initially seropositive subjects: antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer. Titers were determined by Public Health England (PHE) laboratory assay. | The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group) | Posted | | Count of Participants | | Participants | | At Month 61 (one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups) | | | | ID | Title | Description |
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| OG000 | Nimenrix 1 Booster Group Y5 | Subjects who received 1 dose on Nimenrix vaccine at 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG001 | Nimenrix 2 Booster Group Y5 | Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). |
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| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | Assessed solicited local symptoms were pain, redness and swelling. Any was defined as occurrence of the symptom regardless of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness/swelling was defined as redness/swelling spreading beyond 50 millimeters (mm) of injection site. | The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study who had their symptom sheets filled in. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups | | | | ID | Title | Description |
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| OG000 | Nimenrix 1 Booster Group Y5 | Subjects who received 1 dose on Nimenrix vaccine at 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG001 | Nimenrix 2 Booster Group Y5 | Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG002 | Nimenrix Naive Group Y5 | |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal. Any was defined as occurrence of the symptom regardless of their intensity grade or relationship to study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.5 °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 in this current study who had their symptom sheets filled in. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups | | | | ID | Title | Description |
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| OG000 | Nimenrix 1 Booster Group Y5 | Subjects who received 1 dose on Nimenrix vaccine at 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG001 | Nimenrix 2 Booster Group Y5 | Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG002 |
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| Secondary | Number of Subjects Reporting 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 in this current study. | Posted | | Count of Participants | | Participants | | During the 31-day (Days 0-30) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups | | | | ID | Title | Description |
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| OG000 | Nimenrix 1 Booster Group Y5 | Subjects who received 1 dose on Nimenrix vaccine at 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG001 | Nimenrix 2 Booster Group Y5 | Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG002 |
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| Secondary | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study. | Posted | | Count of Participants | | Participants | | During the 181-day (Days 0-180) post primary vaccination for Nimenrix Naive Group and post booster for Nimenrix 1 and Nimenrix 2 Groups | | | | ID | Title | Description |
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| OG000 | Nimenrix 1 Booster Group Y5 | Subjects who received 1 dose on Nimenrix vaccine at 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG001 | Nimenrix 2 Booster Group Y5 | Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG002 | Nimenrix Naive Group Y5 | Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5. |
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| Secondary | Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study. | Posted | | Count of Participants | | Participants | | During the 181-day (Days 0-180) post primary vaccination for Nimenrix Naive Group and post booster for Nimenrix 1 and Nimenrix 2 Groups | | | | ID | Title | Description |
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| OG000 | Nimenrix 1 Booster Group Y5 | Subjects who received 1 dose on Nimenrix vaccine at 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG001 | Nimenrix 2 Booster Group Y5 | Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination). | | OG002 | Nimenrix Naive Group Y5 | Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5. |
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