COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04505722

Janssen Vaccines & Prevention B.V. Clinical Trial

JNJ.CT@sylogent.com

2020-08-10

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

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

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

2

Janssen Vaccines & Prevention B.V.

18

100

Argentina;Brazil;Chile;Colombia;Mexico;Peru;South Africa;United States

Healthy volunteers

N/A

44325

Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status With Onset at Least 14 Days After Double-blind Vaccination on Day 1 (Day 15): Double-blind Phase;Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Seronegative Status With Onset at Least 28 Days After Double-blind Vaccination on Day 1 (Day 29): Double-blind Phase;Number of Participants With Solicited Local Adverse Events (AEs) Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase);Number of Participants With Solicited Systemic AEs Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase);Number of Participants With Unsolicited AEs Up to 28 Days After Booster Vaccination (Open-label Booster Vaccination Phase)

None

Phase 3

[{"arm_notes": "1", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]