Trials / Terminated
TerminatedNCT06252285
Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Phase III, Randomized, Observer-blind, Placebo-controlled, Multi-center, Multinational Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers (PEARL)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 6,300 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 6 Months – 21 Months
- Healthy volunteers
- Accepted
Summary
This study is a phase III, randomized, observer-blind, placebo-controlled, multinational, multi-center study to be conducted in approximately 6300 children 6 months to \< 22 months of age. The purpose of the study is to evaluate the efficacy, immunogenicity, and safety of Respiratory Syncytial Virus Toddler (RSVt) vaccine administered by intranasal route compared to placebo. Eligible participants will be randomized in a 1:1 ratio to receive 2 intranasal administrations of either the RSVt vaccine or placebo. Study duration will be 24 months for each participant. The safety follow-up will start after the first vaccination and up to the end of the study.
Detailed description
Study duration will be 24 months for each participant. The safety follow-up will start at inclusion and up to the end of the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RSVt Vaccine | Pharmaceutical form:Suspension of virus in a nasal spray-Route of administration:Intranasal |
| BIOLOGICAL | Placebo | Pharmaceutical form:Suspension of virus in a nasal spray-Route of administration:Intranasal |
Timeline
- Start date
- 2024-02-06
- Primary completion
- 2025-12-04
- Completion
- 2025-12-04
- First posted
- 2024-02-09
- Last updated
- 2026-02-03
Locations
130 sites across 16 countries: United States, Argentina, Brazil, Chile, China, Colombia, Finland, Japan, Kenya, Mexico, Nepal, Puerto Rico, South Africa, Spain, Thailand, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06252285. Inclusion in this directory is not an endorsement.