At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 304 enrolled
Drug / intervention
Ad26.COV2.Sbiological
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, Observer-blind, Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Dose Levels of Ad26.COV2.S Administered as a One- or Two-dose Regimen in Healthy Adolescents From 12 to 17 Years Inclusive
In Brief
A Phase 2 clinical trial evaluating Ad26.COV2.S for Coronavirus Disease-2019 (COVID-19) Prevention. Completed, enrolled 304 participants across 18 sites in 5 countries.
Detailed Summary
The primary purpose of this study is to assess the safety, reactogenicity, and humoral immune response of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule or as a 2-dose schedule (56-day interval) in adolescents.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Brazil, India, Mexico, South Africa
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
First PostedAug 2021
Enrollment StartSep 2021
Primary CompletionAug 2023
TodayJul 2026
First PostedAug 16, 2021
Enrollment StartSep 27, 2021
Primary CompletionAug 14, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.9 years ago
Interventions
Ad26.COV2.Sbiological
Ad26.COV2.S will be administered as intramuscular (IM) injection.