| Primary | Number of Subjects With Serum Bactericidal Assay /Activity (rSBA) Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Baby Rabbit Complement) Titres ≥ the Cut-off | The cut-off value for the assay was greater than or equal to (≥) 1:8, as measured at the GlaxoSmithKline (GSK) laboratory. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At Month 24 post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y2 | Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y2 | Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| | | Title | Denominators | Categories |
|---|
| rSBA-MenA [M24] | - ParticipantsOG000181
- ParticipantsOG00128
| |
| |
| Primary | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | The cut-off value for the assay was ≥ 1:8. The analysis of this endpoint was performed by GSK. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At Month 36 post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y3 | Subjects from Year 3 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y3 | Subjects from Year 3 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Primary | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | The cut-off value for the assay was ≥ 1:8. The analysis of this endpoint was performed by GSK. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266] , who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At Month 48 post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y4 | Subjects from Year 4 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y4 | Subjects from Year 4 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Primary | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres | The cut-off value for the assay was ≥ 1:8. The rSBA-MenA results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE). | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At Month 36 post-primary vaccination. | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y3 | Subjects from Year 3 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y3 | Subjects from Year 3 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Primary | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres | The cut-off value for the aasay was ≥ 1:8. The rSBA-MenA results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE). | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At Month 48 post-primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y4 | Subjects from Year 4 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y4 | Subjects from Year 4 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off | The cut-off value for the assay was ≥ 1:128, as measured at the GlaxoSmithKline (GSK) laboratory. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At Month 24 post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y2 | Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y2 | Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | The cut-off value for the assay was ≥ 1:128. The analysis of this endpoint was performed by GSK. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At Month 36 post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y3 | Subjects from Year 3 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y3 | Subjects from Year 3 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | The cut-off value for the assay was ≥ 1:128. The analysis of this endpoint was performed by GSK. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At Month 48 post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y4 | Subjects from Year 4 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y4 | Subjects from Year 4 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | The results for the assay were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured at the GlaxoSmithKline (GSK) laboratory | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Geometric Mean | 95% Confidence Interval | Titres | | At Months 24 post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y2 | Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y2 | Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. The analysis of this endpoint was performed by GSK. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Geometric Mean | 95% Confidence Interval | Titres | | At Month 36 post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y3 | Subjects from Year 3 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y3 | Subjects from Year 3 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. The analysis of this endpoint was performed by GSK. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Geometric Mean | 95% Confidence Interval | Titres | | At Month 48 post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y4 | Subjects from Year 4 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y4 | Subjects from Year 4 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | The cut-off for the assay was ≥ 1:128. rSBA-MenA, MenC, MenW and MenY results for the Year 3 time point obtained by re-testing the samples in parallel at Public Health England (PHE). | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At Month 36 post-primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y3 | Subjects from Year 3 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y3 | Subjects from Year 3 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | The cut-off value for the assay was ≥ 1:128. rSBA-MenA, MenC, MenW and MenY results for the Year 4 time point obtained by re-testing the samples in parallel at Public Health England (PHE). | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At Month 48 post-primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y4 | Subjects from Year 4 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y4 | Subjects from Year 4 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. rSBA-MenA, MenC, MenW and MenY results for the Year 3 time point obtained by re-testing the samples in parallel at Public Health England (PHE). | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Geometric Mean | 95% Confidence Interval | Titres | | At Month 36 post-primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y3 | Subjects from Year 3 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y3 | Subjects from Year 3 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. rSBA-MenA, MenC, MenW and MenY results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE). | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Geometric Mean | 95% Confidence Interval | Titres | | At Month 48 post-primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y4 | Subjects from Year 4 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y4 | Subjects from Year 4 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off | The cut-off values for the assay were ≥ 1:4 and 1:8, respectively. The analysis of this endpoint was performed by GSK. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At Month 24 post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y2 | Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y2 | Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off | The cut-off for the assay were ≥ 1:4 and 1:8. The analysis of this endpoint was performed by GSK. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At Month 36 post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y3 | Subjects from Year 3 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y3 | Subjects from Year 3 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off | The cut-off for the assay were ≥ 1:4 and 1:8, as assessed by the GSK laboratory. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At Month 48 post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y4 | Subjects from Year 4 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y4 | Subjects from Year 4 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as assessed by the GSK laboratory. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Geometric Mean | 95% Confidence Interval | Titres | | At Month 24 post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y2 | Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y2 | Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as assessed by the GSK laboratory. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Geometric Mean | 95% Confidence Interval | Titres | | At Month 36 post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y3 | Subjects from Year 3 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y3 | Subjects from Year 3 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured by GSK. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Geometric Mean | 95% Confidence Interval | Titres | | At Month 48 post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y4 | Subjects from Year 4 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y4 | Subjects from Year 4 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | The cut-off values for the assay were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL, respectively, as measured at the GlaxoSmithKline (GSK) laboratory. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At Month 24 post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y2 | Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y2 | Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, 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, as measured by the GSK laboratory. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At Month 36 post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y3 | Subjects from Year 3 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y3 | Subjects from Year 3 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, 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, as measured by GSK. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At Month 48 post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y4 | Subjects from Year 4 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y4 | Subjects from Year 4 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured at the GlaxoSmithKline (GSK) laboratory. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At Month 24 post primary dose | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y2 | Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y2 | Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | The results were tabulated as geometric mean antibody concentration calculated on all subjects, expresssed in μg/mL, as measured by GSK. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At Month 36 post primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y3 | Subjects from Year 3 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y3 | Subjects from Year 3 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | The results were tabulated as geometric mean antibody concentration calculated on all subjects, expresssed in μg/mL, as measured by GSK. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At Month 48 post primary dose | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y4 | Subjects from Year 4 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y4 | Subjects from Year 4 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 0.2 μg/mL. Anti-PS results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE). | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At Month 36 post-primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y3 | Subjects from Year 3 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y3 | Subjects from Year 3 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, 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. Anti-PS results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE). | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At Month 48 post-primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y4 | Subjects from Year 4 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y4 | Subjects from Year 4 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in μg/mL. Anti-PS results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE). Results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At Month 36 post-primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y3 | Subjects from Year 3 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y3 | Subjects from Year 3 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
|
| Secondary | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL. Anti-PS results for the Year 4 time point obtained by re-testing the samples in parallel at Public Health England (PHE). | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At Month 48 post-primary vaccination. | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y4 | Subjects from Year 4 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y4 | Subjects from Year 4 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
|
| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | The cut-off values for the assay were 1:8 and 1:128, as measured by the PHE laboratory. | The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity 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 booster vaccination. | Posted | | Count of Participants | | Participants | | At one month (Month 49) post booster dose | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Month 49 | Subjects from Booster Group vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group). | | OG001 | Meningitec Booster Group (Month 49) | Subjects from Booster Group who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values | The cut off values for the assay were 1:8 and 1:128, as measured by the PHE laboratory. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At 12 months (Month 60) post booster dose | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y5 | Subjects from Year 5 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study | | OG001 | Meningitec Group Y5 | Subjects from Year 5 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured by the PHE laboratory. | The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity 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 booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titres | | At one month (Month 49) post booster dose | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Month 49 | Subjects from Booster Group vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group). | | OG001 | Meningitec Booster Group (Month 49) | Subjects from Booster Group who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | Results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, as measured by the PHE laboratory. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Geometric Mean | 95% Confidence Interval | Titres | | At 12 months (Month 60) post booster dose | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y5 | Subjects from Year 5 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study | | OG001 | Meningitec Group Y5 | Subjects from Year 5 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | The cut off values for the assay were ≥ 1:4 and ≥ 1:8 respectively, as measured by GSK. | The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity 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 booster vaccination. | Posted | | Count of Participants | | Participants | | At one month (Month 49) post booster dose | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Month 49 | Subjects from Booster Group vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group). | | OG001 | Meningitec Booster Group (Month 49) | Subjects from Booster Group who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | The cut off values for the assay were ≥ 1:4 and ≥ 1:8, respectively, as measured by GSK. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At 12 months (Month 60) post booster dose. | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y5 | Subjects from Year 5 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study | | OG001 | Meningitec Group Y5 | Subjects from Year 5 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | The results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, expressed in titres, as measured by GSK. | The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | Titres | | At one month (Month 49) post booster dose | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Month 49 | Subjects from Booster Group vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group). | | OG001 | Meningitec Booster Group (Month 49) | Subjects from Booster Group who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | The results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, expressed in titres, as measured by GSK. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Geometric Mean | 95% Confidence Interval | Titres | | At 12 months (Month 60) post booster dose | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y5 | Subjects from Year 5 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study | | OG001 | Meningitec Group Y5 | Subjects from Year 5 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values | The cut-off values for the assay were 0.3 μg/mL and 2.0 μg/mL, as measured by the PHE laboratory. | The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity 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 booster vaccination. | Posted | | Count of Participants | | Participants | | At one month (Month 49) post booster dose | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Month 49 | Subjects from Booster Group vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group). | | OG001 | Meningitec Booster Group (Month 49) | Subjects from Booster Group who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | The cut-off for the assay were 0.3 μg/mL and 2.0 μg/mL, as measured by the PHE laboratory. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Count of Participants | | Participants | | At 12 months (Month 60) post booster dose | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y5 | Subjects from Year 5 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study | | OG001 | Meningitec Group Y5 | Subjects from Year 5 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured by the PHE laboratory. | The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity 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 booster vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At one month (Month 49) post booster dose | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Month 49 | Subjects from Booster Group vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group). | | OG001 | Meningitec Booster Group (Month 49) | Subjects from Booster Group who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured by the PHE laboratory. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At 12 months (Month 60) post booster dose | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y5 | Subjects from Year 5 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study | | OG001 | Meningitec Group Y5 | Subjects from Year 5 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects Reporting Any Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade. | The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary study (109670) [NCT00474266], with a booster vaccine administration documented and with their symptom sheet filled-in. | Posted | | Count of Participants | | Participants | | During the 8-day period (Days 0-7) after booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Month 49 | Subjects from Booster Group vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group). | | OG001 | Meningitec Booster Group (Month 49) | Subjects from Booster Group who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects Reporting Any Solicited General Symptoms | Solicited general symptoms assessed were drowsiness, irritability, loss of appetite, temperature (measured orally). Any was defined as occurrence of any general symptoms, regardless of their intensity grade or their relationship to vaccination | The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary study (109670) [NCT00474266], with a booster vaccine administration documented, and with the symptom sheet filled-in. | Posted | | Count of Participants | | Participants | | During the 8-day period (Days 0-7) after the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Month 49 | Subjects from Booster Group vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group). | | OG001 | Meningitec Booster Group (Month 49) | Subjects from Booster Group who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects Reporting Any Adverse Events (AEs) | Any was defined as the occurrence of any adverse event regardless of intensity grade or relation to vaccination. 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 regard-less of intensity grade or relation to vaccination. | The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary study (109670) [NCT00474266], with a booster vaccine administration documented, and with their symptom sheet filled-in. | Posted | | Count of Participants | | Participants | | During the 31-day period (Days 0-30) after booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Month 49 | Subjects from Booster Group vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group). | | OG001 | Meningitec Booster Group (Month 49) | Subjects from Booster Group who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
|
| Secondary | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity. | The analysis was performed on the Total cohort for each persistence time point, which included all vaccinated subjects in the primary study (109670) [NCT00474266], who came back to the visit at the considered time point. | Posted | | Count of Participants | | Participants | | At Month 24 post primary dose | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix Group Y2 | Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y2 | Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
| |
| Secondary | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity. | The analysis was performed on the Total cohort for each persistence time point, which included all vaccinated subjects in the primary study (109670) [NCT00474266], who came back to the visit at the considered time point. | Posted | | Count of Participants | | Participants | | At Month 36 | | | | ID | Title | Description |
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| OG000 | Nimenrix Group Y3 | Subjects from Year 3 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y3 | Subjects from Year 3 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
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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 Total cohort for each persistence time point, which included all vaccinated subjects in the primary study (109670) [NCT00474266], who came back to the visit at the considered time point. | Posted | | Count of Participants | | Participants | | At Month 48 | | | | ID | Title | Description |
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| OG000 | Nimenrix Group Y4 | Subjects from Year 4 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | | OG001 | Meningitec Group Y4 | Subjects from Year 4 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
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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 the primary study (109670) [NCT00474266], with a booster vaccine administration documented. | Posted | | Count of Participants | | Participants | | From month 48 to month 49 (post booster follow up period) | | | | ID | Title | Description |
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| OG000 | Nimenrix Group Month 49 | Subjects from Booster Group vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group). | | OG001 | Meningitec Booster Group (Month 49) | Subjects from Booster Group who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
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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 Total cohort for each persistence time point, which included all vaccinated subjects in the primary study (109670) [NCT00474266], who came back to the visit at the considered time point. | Posted | | Count of Participants | | Participants | | From month 49 to month 60 | | | | ID | Title | Description |
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| OG000 | Nimenrix Group Y5 | Subjects from Year 5 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study | | OG001 | Meningitec Group Y5 | Subjects from Year 5 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. |
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