Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RSVt Vaccine · 1 trial · 1 indication
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.
Nasal swabs were collected to assess the shedding of the attenuated RSV vaccine strain and quantified by RSVt qRT PCR assay. Quantified virus shedding was defined as vaccine virus shedding \>=lower limit of quantification (LLOQ=3.37 log10 copies/mL).
Nasal swabs were collected to identify the difference in genetic sequence of mutated vaccine virus segments compared to the reference strain vaccine virus isolates in the vaccine virus positive swabs from pediatric participants receiving placebo after each vaccination. Detected virus shedding was defined as vaccine virus shedding \>=LOD (2.80 log10 copies/mL).
| Arm | Type | Description |
|---|---|---|
| RSVt Vaccine Group | EXPERIMENTAL | 2 intranasal administrations (56 days apart) of the RSVt vaccine at D01 and D57 |
| Control Group | PLACEBO_COMPARATOR | 2 intranasal administrations (56 days apart) of the placebo at D01 and D57 |
| Name | Type | Description |
|---|---|---|
| RSVt Vaccine | BIOLOGICAL | Pharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal |
| Control Group | OTHER | Pharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal |
Inclusion Criteria: * Aged 6 months to \< 24 months on the day of inclusion (from the day of the 6 months after birth to the day before the 2nd birthday) * Participants who are healthy as determined by medical evaluation including medical history. * Born at full term of pregnancy (≥ 37 weeks) or bo...
The RSVt vaccine is an investigational live-attenuated vaccine being developed by Sanofi for the prevention of respiratory syncytial virus infection. It is designed to be given to infants and toddlers, a population at risk of severe RSV disease. It remains in clinical development and is not approved.
The RSVt vaccine is being studied for the prevention of respiratory syncytial virus infection in infants and toddlers 6 to under 24 months of age. RSV is a common cause of lower respiratory tract illness in young children. The vaccine is investigational and has not been approved for use.
Sanofi, which trades on the New York Stock Exchange under the ticker SNY, is developing the RSVt vaccine. The company is the sponsor of the clinical program evaluating the candidate in infants and toddlers. No other developer is named for this asset.
The RSVt vaccine is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently listed as active. The vaccine is investigational and has not been approved by the FDA or any other regulator.
The RSVt vaccine has been evaluated in one completed Phase 1 trial, NCT05687279. That study assessed the safety, transmissibility, and genetic stability of the vaccine virus among close contacts of infants and toddlers 6 to under 24 months of age in Puerto Rico. It enrolled 80 participants.
NCT05687279 was a randomized, double-blind, placebo-controlled Phase 1 study. It enrolled 80 healthy volunteers aged 6 months to under 24 months and was conducted in the United States, including Puerto Rico. The trial evaluated safety, transmissibility, and genetic stability of the vaccine virus among close contacts, and it is now completed.