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
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.
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.
Clinical Trials on Healthy
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University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
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Dragonfly TherapeuticsRecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult MaleAustralia
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University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
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Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
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Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
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Umm Al-Qura UniversityActive, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult SubjectsSaudi Arabia
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Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
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University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
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PfizerNot yet recruitingHealthy | Healthy AdultsUnited States
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RAGE BioRecruitingHealthy | Healthy SmokerAustralia
Clinical Trials on Ad26.COV2.S
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Janssen Vaccines & Prevention B.V.CompletedA Study to Evaluate Dose Levels of Ad26.COV2.S Administered as a Two-dose Schedule in Healthy AdultsCOVID-19 PreventionUnited States, Germany, Brazil, Poland, South Africa
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Janssen Vaccines & Prevention B.V.CompletedCoronavirus Disease-2019 (COVID-19) PreventionMexico, South Africa, Brazil, Argentina, India
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Janssen Vaccines & Prevention B.V.Completed
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Janssen Vaccines & Prevention B.V.Completed
-
Janssen Vaccines & Prevention B.V.CompletedCOVID-19 PreventionUnited States, South Africa, Brazil
-
Centre Hospitalier Universitaire de Saint EtienneTerminated
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University Medical Center GroningenRadboud University Medical Center; Erasmus Medical Center; Academisch Medisch... and other collaboratorsCompletedKidney Diseases | Covid19 | SARS-CoV2 Infection | Vaccine Response ImpairedNetherlands
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Janssen Vaccines & Prevention B.V.CompletedParticipants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19United States, United Kingdom, Belgium, France, Spain, Germany, Philippines, Brazil, Colombia, South Africa
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Janssen Vaccines & Prevention B.V.CompletedParticipants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the ProtocolUnited States, Mexico, South Africa, Brazil, Chile, Colombia, Peru, Argentina