Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Summary
This study is a Phase III, randomized, single-blind, placebo-controlled, multi-center study to be conducted in healthy infants and toddlers which will be enrolled at approximately 6 months of age (Cohort 1) and approximately 12 months of age (Cohort 2). The primary objective of the study will be to assess non-inferiority of the RSV infant and toddler (RSVt) vaccine antibody response when administered concomitantly with routine pediatric vaccines at 6 months of age (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine \[Vaxelis® or Pentacel® and Recombivax HB®\] Prevnar 20®, and RotaTeq®), and 12 months of age (M-M-R II, VARIVAX, and Prevnar 20 or per local country recommendations) compared to when administered non-concomitantly.
Timeline
- Start
- 2024-05-13
- Primary completion
- 2025-09-18
- Completion
- 2025-09-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RSVt Vaccine | Vaccine | — | Intranasal |
| Background | Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine | Vaccine | — | Intramuscular |
| Background | Haemophilus influenzae type b | Vaccine | — | Intramuscular |
| Background | Hepatitis B vaccine | Vaccine | — | Intramuscular |
| Background | Measles, mumps, and rubella vaccine | Vaccine | — | Subcutaneous |
| Background | PCV20 | Vaccine | — | Intramuscular |
| Background | Rotarix | Vaccine | — | Oral |
| Background | Varivax | Vaccine | — | Subcutaneous |