Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly
confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult
participants.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Infectious Diseases
Enrollment Eligibility
Inclusion Criteria:
- Contraceptive (birth control) use should be consistent with local regulations
regarding the acceptable methods of contraception for those participating in clinical
studies
- All participants of childbearing potential must: have a negative highly sensitive
urine pregnancy test at screening; and have a negative highly sensitive urine
pregnancy test immediately prior to each study vaccine administration
- Participant agrees to not donate bone marrow, blood, and blood products from the first
study vaccine administration until 3 months after receiving the last dose of study
vaccine
- Must be willing to provide verifiable identification, has means to be contacted and to
contact the investigator during the study
- Must be able to read, understand, and complete questionnaires in the electronic
clinical outcome assessment (eCOA) (that is, the coronavirus disease-2019 [COVID 19]
signs and symptoms surveillance question, the e-Diary, and the electronic
patient-reported outcomes (ePROs). Note: Participants with visual impairment are
eligible for study participation and may have caregiver assistance in completing the
electronic clinical outcome assessment (eCOA) questionnaires
Exclusion Criteria:
- Participant has a clinically significant acute illness (this does not include minor
illnesses such as diarrhea or mild upper respiratory tract infection) or temperature
greater than or equal to (>=) 38.0 degree Celsius (100.4-degree Fahrenheit) within 24
hours prior to the planned first dose of study vaccine; randomization at a later date
is permitted at the discretion of the investigator and after consultation with the
sponsor
- Participant received or plans to receive: (a) licensed live attenuated vaccines -
within 28 days before or after planned administration of study vaccine ; and (b) other
licensed (not live) vaccines - within 14 days before or after planned administration
of study vaccine
- Participant previously received a coronavirus vaccine
- Participant received an investigational drug (including investigational drugs for
prophylaxis of COVID-19) within 30 days or used an invasive investigational medical
device within 30 days or received investigational immunoglobulin (Ig) or monoclonal
antibodies within 3 months, or received convalescent serum for COVID-19 treatment
within 4 months or received an investigational vaccine (including investigational
Adenoviral-vectored vaccines) within 6 months before the planned administration of the
first dose of study vaccine or is currently enrolled or plans to participate in
another investigational study during the course of this study
Accepts Healthy Volunteers
Call +1 (305) 2434045