At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,544 enrolled
Drug / intervention
RSVPreF3 OA investigational 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.
A Phase 3, Observer-blind, Randomized, Placebo-controlled Study to Evaluate the Non-inferiority of the Immune Response and Safety of the RSVPreF3 OA Investigational Vaccine in Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults ≥60 Years of Age
In Brief
A Phase 3 clinical trial evaluating RSVPreF3 OA investigational vaccine and Placebo for Respiratory Syncytial Virus Infections. Completed, enrolled 1,544 participants.
Detailed Summary
The aim of this study is to demonstrate the non-inferiority (NI) of the immune response and evaluate safety of RSVPreF3 older adults (OA) investigational vaccine in adults 50-59 years of age (YOA), including those who are at increased risk (AIR) of respiratory syncytial virus (RSV)-lower respiratory tract disease (LRTD), versus adults \>=60 YOA
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedOct 2022
Enrollment StartOct 2022
Primary CompletionMar 2023
Study CompletionFeb 2024
TodayJul 2026
First PostedOct 21, 2022
Enrollment StartOct 28, 2022
Primary CompletionMar 13, 2023
Study CompletionFeb 12, 2024
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 3.7 years ago
Interventions
RSVPreF3 OA investigational vaccinebiological
One dose administered intramuscularly at Day 1.
Placebodrug
One dose administered intramuscularly at Day 1.