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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04817657
Expanded Access Status : No longer available
First Posted : March 26, 2021
Last Update Posted : March 26, 2021
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment
Healthy Biological: Ad26.COV2.S

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: COVID Vaccine VAC31518 Pre-approval Access Study

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Intervention Details:
  • Biological: Ad26.COV2.S
    Participants will be administered 0.5 milliliter suspension of Ad26.COV2.S 1*10^11 virus particles per milliliter (vp/ml) as intramuscular injection.
    Other Name: VAC31518, JNJ-78436735

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04817657

Sponsors and Collaborators
Janssen Research & Development, LLC
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04817657    
Other Study ID Numbers: CR109001
VAC31518COV4006 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021