NCT04817657

Brief Summary

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

First QC Date

March 24, 2021

Last Update Submit

March 24, 2021

Conditions

Healthy

Interventions

Ad26.COV2.SBIOLOGICAL

Participants will be administered 0.5 milliliter suspension of Ad26.COV2.S 1\*10\^11 virus particles per milliliter (vp/ml) as intramuscular injection.

Also known as: VAC31518, JNJ-78436735

Sponsors & Collaborators

MeSH Terms

Interventions

Ad26COVS1

Intervention Hierarchy (Ancestors)

COVID-19 VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 26, 2021

Last Updated

March 26, 2021

Record last verified: 2021-03