Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612
Summary
This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in children using Mencevax™ ACWY (in children above 2 years) or Meningitec™ (in children below 2 years) as controls. In the long-term follow-up phase of the study, the long-term protection offered by the vaccines will be assessed up to 5 years after vaccination. Subjects will be randomized in the primary vaccination phase of the study; no new subjects will be enrolled during the long-term follow-up phase of the study.
Timeline
- Start
- 2007-02-07
- Primary completion
- 2007-12-03
- Completion
- 2007-12-03
Outcome
Met primary endpoint
registry Difference in percentage 6.44 (95% CI 1.15 to 16.04) NCT00427908 ↗
registry Difference in percentage 13.18 (95% CI 4.79 to 24.32) NCT00427908 ↗
registry Difference in percentage 4.41 (95% CI 1.51 to 12.21) NCT00427908 ↗
registry Difference in percentage 16.23 (95% CI 8.99 to 26.78) NCT00427908 ↗
Publications
- Background Vesikari T, Forsten A, Boutriau D, Bianco V, Van der Wielen M, Miller JM. A randomized study to assess the immunogenicity, antibody persistence and safety of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in children aged 2-10 years. Hum Vaccin Immunother. 2012 Dec 1;8(12):1882-91. doi: 10.4161/hv.22165. Epub 2012 Oct 2.
- Background Vesikari T, Forsten A, Boutriau D, Bianco V, Van der Wielen M, Miller JM. Randomized trial to assess the immunogenicity, safety and antibody persistence up to three years after a single dose of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in toddlers. Hum Vaccin Immunother. 2012 Dec 1;8(12):1892-903. doi: 10.4161/hv.22166. Epub 2012 Oct 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Mencevax | Vaccine | — | Subcutaneous |
| Comparator | Meningitec | Vaccine | — | Intramuscular |
| Subject | Nimenrix | Vaccine | — | Intramuscular |