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NCT05687279 · ClinicalTrials.gov registry record · Phase 1
Study on a Live-attenuated Respiratory Syncytial Virus Vaccine for Assessment of Safety, Transmissibility, and Genetic Stability of the Vaccine Virus Among Close Contacts in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA)
A Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT05687279: Completed Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT05687279 is a Phase 1 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05687279, a Phase 1 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
The primary purpose of the study is to assess the shedding, transmission, and genetic stability of the live-attenuated RSVt vaccine after each intranasal vaccination (56 days apart) in infants and toddlers 6 to \< 24 months of age.
Primary Outcome
Nasal swabs were collected to assess the presence of vaccine virus after first vaccination. Vaccine virus transmission was defined as presence of detected vaccine virus confirmed by RSVt quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay (vaccine virus shedding \>=lower limit of detection \[LOD=2.80 log10 copies/mL\]) in pediatric participants receiving placebo. Percentages are rounded off to the tenth decimal place.
Interventions
- OTHER Control Group
- BIOLOGICAL RSVt Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2023-02-06 |
| Est. Completion | 2024-12-27 |
| Phase | Phase 1 |
What the finished NCT05687279 record still lists
NCT05687279 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 2 interventions - of which Control Group is the first listed.
NCT05687279 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05687279 about?
NCT05687279 is a clinical study titled "Study on a Live-attenuated Respiratory Syncytial Virus Vaccine for Assessment of Safety, Transmissibility, and Genetic Stability of the Vaccine Virus Among Close Contacts in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA)". The primary purpose of the study is to assess the shedding, transmission, and genetic stability of the live-attenuated RSVt vaccine after each intranasal vaccination (56 days apart) in infants and toddlers 6 to \< 24 months of age.
What is the current status of trial NCT05687279?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2023-02-06. Estimated completion is 2024-12-27.
What interventions are being tested in trial NCT05687279?
The interventions under investigation include: Control Group (OTHER), RSVt Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05687279?
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 NCT05687279's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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