drugset / Trial / NCT03673462
Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The primary objective of this study was to describe the safety profile of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine and Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) Conjugate Vaccine when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers.
Timeline
- Start
- 2018-09-17
- Primary completion
- 2023-03-16
- Completion
- 2023-03-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MenACYW conjugate vaccine | Vaccine | — | Intramuscular |
| Comparator | Menveo | Vaccine | — | Intramuscular |
| Background | Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine | Vaccine | — | Intramuscular |
| Background | Hepatitis B vaccine | Vaccine | — | Intramuscular |
| Background | Measles, mumps, and rubella virus vaccine, live | Vaccine | — | Subcutaneous |
| Background | Prevnar 13 | Vaccine | — | Intramuscular |
| Background | Rotarix | Vaccine | — | Oral |
| Background | Varivax | Vaccine | — | Subcutaneous |
Indications
No indication recorded.