At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 250 enrolled
Drug / intervention
Ad26.RSV.preF-based 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 Randomized, Double-blind Phase 3 Study to Compare the Immunogenicity of Clinical Trial Material of an Ad26.RSV.preF-based Vaccine for Phase 3 With Clinical Trial Material Representative of Phase 2b in Adults Aged 60 to 75 Years
In Brief
A Phase 3 clinical trial evaluating Ad26.RSV.preF-based vaccine for Respiratory Syncytial Virus Prevention. Completed, enrolled 250 participants across 9 sites.
Detailed Summary
The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses induced by vaccination with one dose of the Phase 3 clinical trial material (CTM) compared with one dose of the Phase 2b CTM.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Prevention
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
Enrollment StartOct 2021
First PostedOct 2021
Primary CompletionMar 2022
Study CompletionSep 2022
TodayJul 2026
First PostedOct 19, 2021
Enrollment StartOct 8, 2021
Primary CompletionMar 7, 2022
Study CompletionSep 22, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 4.7 years ago
Interventions
Ad26.RSV.preF-based vaccinebiological
Ad26.RSV.preF-based vaccine will be administered as a single intramuscular injection.