At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 459 enrolled
Drug / intervention
RSV 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 Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels of an Ad26.RSV.preF-based Vaccine in Adults Aged 60 Years and Older
In Brief
A Phase 2 clinical trial evaluating RSV Vaccine and Placebo for Healthy. Completed, enrolled 459 participants across 9 sites.
Detailed Summary
The purpose of this study is to explore the dose-response relationship of immune responses induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine (Cohorts 2 and 3).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartJul 2020
Primary CompletionSep 2020
Study CompletionApr 2021
TodayJul 2026
First PostedJul 1, 2020
Enrollment StartJul 16, 2020
Primary CompletionSep 24, 2020
Study CompletionApr 9, 2021
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.0 years ago
Interventions
RSV Vaccinebiological
Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
Placeboother
Participants will receive a single IM injection of placebo on Day 1.