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A Study of Ad26.COV2.S in Adults (COVID-19)

NCT04436276 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1085

Last updated 2025-02-04

Study results available
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Summary

The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S at 2 dose levels, administered intramuscularly (IM) as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort in healthy adults aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 years and in adults aged \>= 65 years in good health with or without stable underlying conditions. The purpose of the study is also to assess the safety and reactogenicity of Ad26.COV2.S administered as ad hoc booster vaccination in healthy adults aged \>= 18 to \<= 55 years and in adults \>= 65 years in good health with or without stable underlying conditions.

Conditions

  • Covid-19 Prevention

Interventions

BIOLOGICAL

Ad26.COV2.S

Participants will receive intramuscular (IM) injection of Ad26.COV2.S.

BIOLOGICAL

Placebo

Participants will receive Placebo.

Sponsors & Collaborators

  • Janssen Vaccines & Prevention B.V.

    lead INDUSTRY

Principal Investigators

  • Janssen Vaccines & Prevention B.V. Clinical Trial · Janssen Vaccines & Prevention B.V.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2023-02-21
Completion
2023-02-21
FDA Drug
Yes

Countries

  • United States
  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04436276 on ClinicalTrials.gov