A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants
Condition: Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol
MeSH terms: COVID-19
Intervention: Ad26.COV2.S; Placebo
Intervention description: Ad26.COV2.S will be administered at a single dose of 5*10^10 virus particles (vp) on Day 1 (or Month 6 for placebo recipients) and as a single booster dose at Year 1.; Participants will receive Placebo.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44325.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prevention; Vaccine

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.
    

Eligibility criteria:

        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