drugset / Trial / NCT06647407
Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study is the first study of Sanofi's Pentavalent Meningococcal ABCYW vaccine clinical development program to be conducted in the pediatric population below 10 years of age. The aim of the study is to assess 2 formulations of the MenPenta vaccine compared to licensed meningococcal vaccines when administered alone in children (Stage 1) or concomitantly with routine pediatric vaccines in toddlers (Stage 2) and infants (Stage 3). Study details include: The study duration per participant will be up to 12 months for children in Stage 1 and toddlers in Stage 2 and 16 to-19 months for infants in Stage 3.
Timeline
- Start
- 2024-11-05
- Primary completion
- 2027-05-17
- Completion
- 2027-05-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bexsero | Vaccine | — | Intramuscular |
| Comparator | MenACYW conjugate vaccine | Vaccine | — | Intramuscular |
| Subject | Pentavalent Meningococcal ABCYW vaccine | Vaccine | — | Intramuscular |
| Background | Acetaminophen | Small molecule | — | Oral |
| Background | Infanrix hexa | Vaccine | — | Intramuscular |
| Background | Infanrix hexa | Vaccine | — | Oral |
| Background | Prevnar 13 | Vaccine | — | Intramuscular |
| Background | Rotarix | Vaccine | — | Intramuscular |