At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 755 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 Assess the Immunogenicity and Safety of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life 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 755 participants across 13 sites.
Detailed Summary
The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Prevention
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedNov 2021
Enrollment StartNov 2021
Primary CompletionMar 2022
Study CompletionSep 2022
TodayJul 2026
First PostedNov 1, 2021
Enrollment StartNov 1, 2021
Primary CompletionMar 28, 2022
Study CompletionSep 20, 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 single IM injection.