CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 44,325 enrolled
Drug / intervention
Ad26.COV2.S +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.

Search/NCT04505722
NCT04505722Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older

Janssen Vaccines & Prevention B.V.·interventional·Posted Aug 10, 2020·Updated Feb 4, 2025

In Brief

A Phase 3 clinical trial evaluating Ad26.COV2.S and Placebo for Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol. Completed, enrolled 44,325 participants across 225 sites in 8 countries.

Detailed Summary

The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParticipants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol
CountriesArgentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedAug 10, 2020
Enrollment StartSep 7, 2020
Primary CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 5.9 years ago

Interventions

Ad26.COV2.Sbiological

Ad26.COV2.S will be administered at a single dose of 5\*10\^10 virus particles (vp) on Day 1 (or Month 6 for placebo recipients) and as a single booster dose at Year 1.

Placeboother

Participants will receive Placebo.