Trials / Completed
CompletedNCT05687279
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)
Phase II, Randomized, Observer-blind, Placebo-controlled, Multi-center Study of a Live Attenuated Respiratory Syncytial Virus Vaccine to Assess the Vaccine Virus' Transmissibility in Household or Daycare Center Settings, Shedding, and Genetic Stability, and to Describe the Immunogenicity and Safety of the Vaccine in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 6 Months – 23 Months
- Healthy volunteers
- Accepted
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.
Detailed description
The duration of each participant's participation is up to 8 months, including the 6 months safety follow-up phone call after the second study intervention administration for the pediatric participants The treatment administration for the pediatric participants will be on D01 and D57 (1 intranasal administration each).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RSVt Vaccine | Pharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal |
| OTHER | Control Group | Pharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal |
Timeline
- Start date
- 2023-02-06
- Primary completion
- 2024-12-27
- Completion
- 2024-12-27
- First posted
- 2023-01-18
- Last updated
- 2026-01-26
- Results posted
- 2026-01-26
Locations
6 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05687279. Inclusion in this directory is not an endorsement.