At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,471 enrolled
Drug / intervention
RSVpreF Vaccine +2 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, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE IN ADULTS ≥65 YEARS OF AGE
In Brief
A Phase 3 clinical trial evaluating RSVpreF Vaccine, Placebo, and 1 other intervention for Respiratory Syncytial Virus. Completed, enrolled 1,471 participants across 33 sites.
Detailed Summary
The purpose of this study is to assess the safety and immunogenicity of RSVpreF when coadministered with SIIV compared to sequential administration of the vaccines when given 1 month apart (SIIV followed by RSVpreF). Additionally, the study will contribute data supporting the development of RSVpreF as a prophylactic vaccine against RSV disease in infants through maternal immunization and in older adults through active vaccination.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus
CountriesAustralia
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedMar 2022
Enrollment StartApr 2022
Primary CompletionOct 2022
TodayJul 2026
First PostedMar 29, 2022
Enrollment StartApr 13, 2022
Primary CompletionOct 12, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 4.3 years ago
Interventions
RSVpreF Vaccinebiological
RSV Vaccine
Placeboother
Placebo
Seasonal Inactivated Influenza Vaccinebiological
SIIV