A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers
Summary
The purpose of this study was to evaluate the optimal vaccination schedule for a Quadrivalent Meningococcal Polysaccharide (A, C, Y and W-135) Tetanus Protein Conjugate Vaccine (MenACYW Conjugate vaccine) in order to provide an effective protein conjugate quadrivalent meningococcal vaccine in the population with the highest incidence of disease. Objectives: * To describe the safety profile of MenACYW Conjugate vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations. * To describe the immunogenicity profile of MenACYW Conjugate vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations. * To describe the immunogenicity profiles of selected licensed pediatric vaccines (Pentacel, Prevnar, M-M-RII, and Varivax) when administered either concomitantly with or without MenACYW Conjugate vaccine.
Timeline
- Start
- 2009-12-16
- Primary completion
- 2012-02-13
- Completion
- 2012-02-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined) | Vaccine | 0.5 ml | Intramuscular |
| Subject | Hepatitis B vaccine | Vaccine | 0.5 ml | Intramuscular |
| Subject | M-M-R II | Vaccine | 0.5 ml | Subcutaneous |
| Subject | Prevnar 13 | Vaccine | 0.5 ml | Intramuscular |
| Subject | Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate | Vaccine | 0.5 ml | Intramuscular |
| Subject | Rotarix | Vaccine | — | Oral |
| Subject | Varivax | Vaccine | 0.5 ml | Subcutaneous |