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NCT06252285 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Terminated
- Registry status
- Phase 3
- Development phase
- 6,300
- Enrollment target
NCT06252285: Clinical Trial Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT06252285 is a Phase 3 study that was terminated before completion, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 6,300 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (716% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06252285, a Phase 3 study, was terminated before completion, sponsored by Sanofi Pasteur, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 6,300 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL RSVt Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,300 participants |
| Start Date | 2024-02-06 |
| Est. Completion | 2025-12-04 |
| Phase | Phase 3 |
Why NCT06252285 stopped before completion
NCT06252285 is an interventional study that assigns participants to a tested intervention. Its 6,300 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (716% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06252285 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06252285 about?
NCT06252285 is a clinical study titled "Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers". 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...
What is the current status of trial NCT06252285?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 6,300 participants. The study started on 2024-02-06. Estimated completion is 2025-12-04.
What interventions are being tested in trial NCT06252285?
The interventions under investigation include: Placebo (BIOLOGICAL), RSVt Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT06252285?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06252285's enrollment target sits among peer trials
6,300 35th of 2000 higher than 1,966 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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