NCT04505722

A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44,325 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol

Interventions

Type	Name	Description
BIOLOGICAL	Ad26.COV2.S	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.
OTHER	Placebo	Participants will receive Placebo.

Timeline

• Start date: 2020-09-07
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2020-08-10
• Last updated: 2025-02-04
• Results posted: 2022-04-15

Locations

225 sites across 8 countries: United States, Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa

Regulatory

• FDA-regulated drug study