A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older

CompletadoFase 3ClinicalTrials.gov

ID: NCT04505722Tipo: INTERVENTIONALInicio: 7 de sept de 2020Fin estimado: 31 de mar de 2023

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

biological

Ad26.COV2.S

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.

other

Placebo

Participants will receive Placebo.

Ubicaciones

Clínica y Maternidad Suizo Argentina

Buenos Aires, Argentina

CIPREC

Buenos Aires, Argentina

Helios Salud Sa

Buenos Aires, Argentina

CEMEDIC

Buenos Aires, Argentina

Centro Medico Viamonte SRL

Ciudad Autonoma Buenos Aires, Argentina

Clinical Trials Division-Stamboulian Servicios de Salud

Ciudad Autonoma Buenos Aires, Argentina

Fundacion Huesped

Ciudad Autonoma de Buenos Aire, Argentina

CEMIC Saavedra

Ciudad de Buenos Aires, Argentina

Hospital J. M. Ramos Mejía

Ciudad de Buenos Aires, Argentina

Instituto Medico Platense

La Plata, Argentina

Hospital Italiano de La Plata

La Plata, Argentina

DIM Clinica Privada

Ramos Mejía, Argentina

Patrocinadores

PrincipalJanssen Vaccines & Prevention B.V.

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