At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,045 enrolled
Drug / intervention
RSVPreF3 OA 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 III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of an RSVPreF3 OA Investigational Vaccine When Co-administered With FLU aQIV (Inactivated Influenza Vaccine - Adjuvanted) in Adults Aged 65 Years and Above
In Brief
A Phase 3 clinical trial evaluating RSVPreF3 OA vaccine and FLU vaccine for Respiratory Syncytial Virus Infections. Completed, enrolled 1,045 participants across 37 sites in 5 countries.
Detailed Summary
The aim of this study is to assess the immunogenicity, safety and reactogenicity of the RSV PreFusion protein 3 older adult (RSVPreF3 OA) investigational vaccine when co-administered with an adjuvanted quadrivalent influenza (FLU aQIV) vaccine, in adults aged 65 years of age (YOA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesBelgium, Finland, France, Spain, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedOct 2022
Enrollment StartOct 2022
Primary CompletionFeb 2023
Study CompletionJul 2023
TodayJul 2026
First PostedOct 6, 2022
Enrollment StartOct 14, 2022
Primary CompletionFeb 17, 2023
Study CompletionJul 17, 2023
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 3.7 years ago
Interventions
RSVPreF3 OA vaccinebiological
One dose of RSVPreF3 OA vaccine administered intramuscularly.
FLU vaccinebiological
One dose of FLU vaccine administered intramuscularly.