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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06252285
The ClinicalTrials.gov registry entry for NCT06252285 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 6,300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06252285 reports 0 study locations.
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.
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