A Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S vaccine for the Prevention of COVID-19 disease in Adults Aged 18 Years and Older

Phase 1

• Conditions: MedDRA version: 23.1Level: LLTClassification code 10084465Term: COVID-19 vaccinationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]; Healthy Volunteers, with or without comorbidities (Prevention of SARS-CoV-2-mediated COVID-19)

• Registration Number: EUCTR2020-003643-29-GB
• Lead Sponsor: Janssen Vaccines & Prevention B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-05
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30000

Inclusion Criteria

1. Participant is =18 to <60 years or =60 yearsof age on the day of signing the ICF.
2. Stage 1: In the investigator’s clinical judgement, participant must be either in good or stable health, including a BMI <30 kg/m2.
Participants may have underlying illnesses (not associated with increased risk of progression to severe COVID-19 as specified in Exclusion Criteria), as long as their symptoms and signs are stable and well-controlled. If participants are on medication for a condition not part of the comorbidities listed in Exclusion Criteria, the medication dose cannot have been increased within 12 weeks preceding the 1st vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of relevant medical history and BMI at screening.
As of Stage 2: In the investigator’s clinical judgement, participant may have a stable and well-controlled comorbidity including comorbidities associated with an increased risk of progression to severe COVID-19 as specified in Exclusion Criteria (eg, stable/well-controlled HIV infection).
If participants are on medication for comorbidity (including comorbidities associated with an increased risk of progression to severe COVID-19), the medication dose cannot have been increased within 12 weeks preceding the 1st vaccination and must be expected to remain stable for the duration of the study. Participants will be included on the basis of relevant medical history and BMI at screening.
3. Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies.
4. Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after the last dose of the study vaccine.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 21000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9000

Exclusion Criteria

1. Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature =38.0ºC (100.4°F) within 24 hours prior to the planned 1st dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor.
2. Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine).
3. Participant has abnormal function of the immune system resulting from:
a. Clinical conditions (eg, autoimmune disease or potential immune mediated disease or known or suspected immunodeficiency, or patient on hemodialysis) expected to have an impact on the immune response of the study vaccine. Participants with clinical conditions stable under non-immunomodulator treatment (eg, autoimmune thyroiditis, autoimmune inflammatory rheumatic disease such as rheumatoid arthritis) may be enrolled at the discretion of the investigator. Non-immunomodulator treatment is allowed as well as steroids at a non-immunosuppressive dose or route of administration.
b. Chronic (>10 days) or recurrent use of systemic corticosteroids within 6 months before administration of the 1st dose of study vaccine and during the study. A substantially immunosuppressive steroid dose is considered to be =2 weeks of daily receipt of 20 mg of prednisone or equivalent. Ocular, topical or inhaled steroids are allowed.
c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 6 months before administration of the 1st dose of study vaccine and during the study.
4. Participant received treatment with Ig in the 3 months or blood products in the 4 months before the planned administration of the 1st dose of study vaccine or has any plans to receive such treatment during the study.
5. Participant received or plans to receive:
a. Licensed live attenuated vaccines – within 28 days before or after planned administration of the 1st or subsequent study vaccinations.
b. Other licensed (not live) vaccines – within 14 days before or after planned administration of the 1st or subsequent study vaccinations.
6. Participant previously received a coronavirus vaccine.
7. Participant received an investigational drug within 30 days(including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days or received investigational Ig or investigational 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 1st dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study.
8. Participant is pregnant or planning to become pregnant within 3 months after the last dose of study vaccine.
9. Participant has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the wellbeing) or that could prevent, limit, or confound the protocol-specified assessments.
10. Stage 1: Participants with comor

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified