Phase
Condition
Corona Virus
Coronavirus
Treatment
Ad26.COV2.S
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Cohort 1: Participant received Ad26.COV2.S in VAC31518COV3001. The interval betweenthe Ad26.COV2.S primary vaccination should preferably be greater than or equal to (>=) 6 months prior to study vaccination on VAC31518COV2008, however a window ofmaximum -20 days is allowed; Cohort 2: Participant completed primary vaccinationwith a 2-dose regimen of BNT162b2 vaccine. The last dose of BTN162b2 shouldpreferably be >=6 months prior to study vaccination on COV2008, however a window ofa maximum of -20 days is allowed
Participant must provide consent indicating that he or she understands the purpose,procedures and potential risks and benefits of the study, and is willing toparticipate in the study
Participant agrees to not donate bone marrow, blood, and blood products from thestudy vaccine administration until 3 months after receiving the study vaccine
Participant must be willing to provide verifiable identification, has means to becontacted and to contact the investigator during the study
Participant must be able to read, understand, and complete questionnaires in theelectronic clinical outcome assessment (eCOA) (that is, the Coronavirus disease (COVID-19) signs and symptoms surveillance question, the e-Diary, and the electronicpatient-reported outcomes (ePROs). Participants with visual impairment are eligiblefor study participation and may have caregiver assistance in completing the eCOAquestionnaires
Exclusion
Exclusion Criteria:
Participant has a clinically significant acute illness (this does not include minorillnesses such as diarrhea or mild upper respiratory tract infection) or temperature >= 38.0 degree Celsius (C) (100.4 degree Fahrenheit [F]) within 24 hours prior tothe planned study vaccination; randomization at a later date is permitted at thediscretion of the investigator. Please notify the sponsor (or medical monitor) ofthis decision
Participant has a known or suspected allergy or history of anaphylaxis or otherserious adverse reactions to vaccines or their excipients (including specificallythe excipients of the study vaccine
Participant received treatment with immunoglobulins (Ig) in the 3 months orexogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the study vaccine or has any plans toreceive such treatment during the study
Participant has a known history of confirmed severe acute respiratory syndromecoronavirus-2 (SARS-CoV-2) infection
Participant has a history of heparin-induced thrombocytopenia or thrombosis incombination with thrombocytopenia
Participant has a history of acute polyneuropathy (example. Guillain-Barre syndrome)
History of capillary leak syndrome
Study Design
Connect with a study center
Central Phoenix Medical Clinic
Phoenix, Arizona 85020
United StatesSite Not Available
Synexus Clinical Research US Inc
Tucson, Arizona 85741
United StatesSite Not Available
Synexus Clinical Research US, Inc
Tucson, Arizona 85741
United StatesSite Not Available
Anaheim Clinical Trials, LLC
Anaheim, California 92801
United StatesSite Not Available
Ark Clinical Research
Long Beach, California 90815
United StatesSite Not Available
Velocity Clinical Research
North Hollywood, California 91606
United StatesSite Not Available
Velocity Clinical Research, Denver
Denver, Colorado 80209
United StatesSite Not Available
Velocity Clinical Research, Hallandale Beach
Hallandale Beach, Florida 33009
United StatesSite Not Available
Research Centers of America, LLC
Hollywood, Florida 33024
United StatesSite Not Available
Synexus Clinical Research US Inc
Orlando, Florida 32806
United StatesSite Not Available
Synexus Clinical Research US, Inc
Orlando, Florida 32806
United StatesSite Not Available
Synexus Clinical Research US Inc
The Villages, Florida 32162
United StatesSite Not Available
Synexus Clinical Research US, Inc
The Villages, Florida 32162
United StatesSite Not Available
Optimal Research
Peoria, Illinois 61614
United StatesSite Not Available
Johnson County Clin-Trials
Lenexa, Kansas 66219
United StatesSite Not Available
University of Kentucky
Lexington, Kentucky 40536
United StatesSite Not Available
Clinical Trials Management, LLC
Metairie, Louisiana 70006
United StatesSite Not Available
Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Rochester Clinical Research, Inc
Rochester, New York 14609
United StatesSite Not Available
Velocity Clinical Research, Anderson
Anderson, South Carolina 29621
United StatesSite Not Available
Accellacare US Inc
Mount Pleasant, South Carolina 29464
United StatesSite Not Available
Coastal Carolina Research Center
North Charleston, South Carolina 29405
United StatesSite Not Available
Crofoot Research Center
Houston, Texas 77098
United StatesSite Not Available
Velocity Clinical Research, Salt Lake City
West Jordan, Utah 84088
United StatesSite Not Available

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