At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,459 enrolled
Drug / intervention
RSVPreF3 OA investigational vaccinebiological
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.
A Phase 3b, Open-label Study to Evaluate the Non-inferiority of the Immune Response and to Evaluate the Safety of the RSVPreF3 OA Investigational Vaccine in Adults 18-49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults >=60 Years of Age
In Brief
A Phase 3 clinical trial evaluating RSVPreF3 OA investigational vaccine for Respiratory Syncytial Virus Infections. Completed, enrolled 1,459 participants across 52 sites in 6 countries.
Detailed Summary
The aim of this study is to demonstrate the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for RSV disease, compared to older adults (OA) 60 YOA and above.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesAustralia, Canada, Germany, Japan, South Africa, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20252026
First PostedApr 2024
Enrollment StartApr 2024
Primary CompletionJul 2024
Study CompletionMar 2025
TodayJul 2026
First PostedApr 29, 2024
Enrollment StartApr 29, 2024
Primary CompletionJul 29, 2024
Study CompletionMar 18, 2025
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 2.2 years ago
Interventions
RSVPreF3 OA investigational vaccinebiological
1 dose of RSVPreF3 OA investigational vaccine is administered intramuscularly on Day 1.