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

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ClinicalTrials.gov Identifier: NCT04817657
Expanded Access Status : No longer available
First Posted : March 26, 2021
Last Update Posted : March 26, 2021
Sponsor:
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



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

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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
Investigators
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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