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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...
RSVt Vaccine is an investigational live-attenuated vaccine being studied for the prevention of Respiratory Syncytial Virus (RSV) infection in infants and toddlers aged 6 to less than 24 months. It is currently in Phase 1 clinical development and is not yet approved for use.
RSVt Vaccine is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. The vaccine is in Phase 1 clinical development for Respiratory Syncytial Virus infection.
RSVt Vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed to assess its safety, transmissibility, and genetic stability.
RSVt Vaccine has one completed Phase 1 clinical trial, identified as NCT05687279. This study enrolled 80 participants and evaluated the safety, transmissibility, and genetic stability of the vaccine virus among close contacts in infants and toddlers aged 6 to less than 24 months in Puerto Rico, USA.
No, RSVt Vaccine is a live-attenuated vaccine, not a monoclonal antibody. It is designed to prevent Respiratory Syncytial Virus infection by using a weakened form of the virus to stimulate an immune response. It is currently in Phase 1 clinical development.