Pre-approval Access for Janssen's COVID Vaccine VAC31518 for Treating Physician Use

March 24, 2021 updated by: Janssen Research & Development, LLC

COVID Vaccine VAC31518 Pre-approval Access Study

The purpose of this Pre-approval access (PAA) program is to provide VAC31518 (Ad26.CoV2.S) vaccine for the prevention of coronavirus disease-2019 (COVID-19) infection. This PAA program may be considered to protect participants against a serious/life-threatening diseases or conditions, where there are no alternative treatments available.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 24, 2021

First Submitted That Met QC Criteria

March 24, 2021

First Posted (Actual)

March 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 26, 2021

Last Update Submitted That Met QC Criteria

March 24, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • CR109001
  • VAC31518COV4006 (Other Identifier: Janssen Research & Development, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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