At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 80 enrolled
Drug / intervention
RSVt Vaccine +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating RSVt Vaccine and Control Group for Respiratory Syncytial Virus Infection. Completed, enrolled 80 participants across 6 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infection
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
First PostedJan 2023
Enrollment StartFeb 2023
Primary CompletionDec 2024
TodayJul 2026
First PostedJan 18, 2023
Enrollment StartFeb 6, 2023
Primary CompletionDec 27, 2024
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 3.5 years ago
Interventions
RSVt Vaccinebiological
Pharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal
Control Groupother
Pharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal