Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05687279 | 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) | PHASE1 | COMPLETED | 80 | — | — | Feb 6, 2023 | Dec 27, 2024 | Jan 26, 2026 | 6 | United States, Puerto Rico |
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...