At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,124 enrolled
Drug / intervention
Ad26.RSV.preF-based 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 3 Study to Evaluate the Safety and Immunogenicity of an Ad26.RSV.preF-based Vaccine in Adults Aged 18 to 59 Years, Including Those at High-risk for Severe RSV
In Brief
A Phase 3 clinical trial evaluating Ad26.RSV.preF-based Vaccine and Placebo for Respiratory Syncytial Virus Infection Prevention. Completed, enrolled 1,124 participants across 23 sites in 5 countries.
Detailed Summary
The purpose of the study is to investigate the safety and immunogenicity of the Ad26.RSV.preF based vaccine in adults 18 to 59 years of age who are healthy or at risk for severe Respiratory Syncytial Virus (RSV) disease, compared to adults 65 years and above.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Germany, Spain, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
Enrollment StartSep 2021
First PostedOct 2021
Primary CompletionAug 2022
TodayJul 2026
First PostedOct 7, 2021
Enrollment StartSep 29, 2021
Primary CompletionAug 12, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.7 years ago
Interventions
Ad26.RSV.preF-based Vaccinebiological
Participants will receive a single IM injection of an RSV vaccine.
Placeboother
Participants will receive a single IM injection of matching placebo.