Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Stopped early · Phase 3 · Has a placebo group
Conditions studied: RSV Immunisation
In brief
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.
Key facts
- Study ID
- NCT06252285
- Run by
- Sanofi Pasteur, a Sanofi Company
- People needed
- 6300
- Starts
- 2024-02-06
- Expected to finish
- 2025-12-04
- Last updated by the study team
- 2026-02-03
Who can join
Age: 1 and older, up to 2. Sex: any. Healthy volunteers: accepted.
Where it is running
- Lakeview Clinical Research- Site Number : 8400024 — Guntersville, Alabama, United States
- Novak Clinical Research- Site Number : 8400069 — Tucson, Arizona, United States
- Madera Family Medical Group- Site Number : 8400029 — Madera, California, United States
- Integrated Clinical Research- Site Number : 8400056 — Tarzana, California, United States
- National Institute of Clinical Research - Victorville - Hesperia Road- Site Number : 8400040 — Victorville, California, United States
- Moore Clinical Research - Brandon- Site Number : 8400065 — Brandon, Florida, United States
- Invictus Clinical Research Group- Site Number : 8400035 — Coconut Creek, Florida, United States
- Site Number : 8400031 — Doral, Florida, United States
- Nona Pediatric Center- Site Number : 8400068 — Orlando, Florida, United States
- Teena Hughes Pediatrics- Site Number : 8400042 — Tampa, Florida, United States
- Morehouse School of Medicine - Atlanta- Site Number : 8400037 — Atlanta, Georgia, United States
- Emory-Children's Center- Site Number : 8400001 — Atlanta, Georgia, United States
- Agile Clinical Research Trials- Site Number : 8400015 — Atlanta, Georgia, United States
- Tekton Research, LLC - 4961 Buford Hwy - Georgia - PPDS- Site Number : 8400064 — Chamblee, Georgia, United States
- Velocity Clinical Research - (Macon - Georgia) - PPDS- Site Number : 8400041 — Macon, Georgia, United States
- iResearch Savannah - CenExel - PPDS- Site Number : 8400032 — Savannah, Georgia, United States
- Medical Research Partners - Ammon- Site Number : 8400059 — Ammon, Idaho, United States
- Clinical Research Prime- Site Number : 8400013 — Idaho Falls, Idaho, United States
- Leavitt Women's Healthcare- Site Number : 8400033 — Idaho Falls, Idaho, United States
- Snake River Research- Site Number : 8400046 — Idaho Falls, Idaho, United States
- Michigan Institute of Research- Site Number : 8400055 — Allen Park, Michigan, United States
- Vida Clinical Studies - Dearborn Heights- Site Number : 8400072 — Dearborn Heights, Michigan, United States
- Great Lakes Research Institute- Site Number : 8400060 — Southfield, Michigan, United States
- Clinical Research Institute - Minneapolis- Site Number : 8400011 — Minneapolis, Minnesota, United States
- Central Research Associates - Flourish - PPDS- Site Number : 8400009 — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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