A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

31,835

Participants

Timeline

Start Date

November 12, 2020

Primary Completion Date

June 18, 2023

Study Completion Date

June 18, 2023

Conditions
Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19
Interventions
BIOLOGICAL

Ad26.COV2.S

Ad26.COV2.S vaccine will be administered on Day 1 and Day 57 in the double-blind phase. At unblinding visit Ad26.COV2.S vaccine will be administered to participants at Day 57 who have not yet received second vaccination and in newly enrolled participants as either single dose on Day 1 or two doses on Day 1 and Day 57. Single dose of Ad26.COV2.S vaccine will also be administered to participants initially receiving placebo. Single booster dose of Ad26.COV2.S vaccine will be given to participants in the open label phase who have received only a single vaccination with Ad26.COV2.S.

OTHER

Placebo

Placebo will be administered as IM injection on Day 1 and Day 57.

Trial Locations (126)

1000

Makati Medical Center, Manila

Medical Center Manila, Manila

1022

Dr AA Mahomed Medical Centre, Moloto South

1230

Tropical Disease Foundation, Makati

1501

Worthwhile Clinical trials, Johannesburg

1619

Peermed Clinical Trial Centre, Kempton Park

2000

Institute of Tropical Medicine Antwerp, Antwerp

2800

Az Sint-Maarten, Mechelen

3000

UZ Leuven, Leuven

3570

Anima, Alken

5000

West Visayas State University Medical Center, Iloilo City

5101

Private Practice RESPISOM Namur, Namur

6100

Riverside Medical Center, Bacolod

7130

Dr J.M. Engelbrecht Trial Site, Somerset West

7500

TREAD Research Tygerberg Hospital, Cape Town

7626

Be Part Yoluntu Centre, Western Cape

7700

Centre of Tuberculosis Research Innovation, Cape Town

8035

Hosp Univ Vall D Hebron, Barcelona

9000

Center for Vaccinology (CEVAC), Ghent

10312

Richmond Behavioral Associates, Staten Island

13760

Meridian Clinical Research, LLC, Endwell

Regional Clinical Research, Inc., Endwell

14618

Allergy Asthma Immunology of Rochester, PC (AAIR) - Research Center, Rochester

20850

Optimal Research, Rockville

20854

Meridian Clinical Research, LLC, Rockville

21075

Centennial Medical Group, Elkridge

23502

Alliance for Multispeciality Research, Norfolk

28006

Hosp. Univ. de La Princesa, Madrid

28027

Clinica Univ. de Navarra, Madrid

28046

Hosp. Univ. de La Paz, Madrid

28207

American Health Network, LLC, Charlotte

28223

Hosp. Quiron Madrid Pozuelo, Madrid

28401

Wilmington Health Associates, Wilmington

29425

Medical University of South Carolina, Charleston

29464

Coastal Carolina Research Center, Mt. Pleasant

30331

Atlanta Center for Medical Research, Atlanta

31008

Clinica Univ. de Navarra, Pamplona

31054

Hopital Rangueil, Toulouse

31059

Hopital Purpan, Toulouse

31204

Accel Research Sites, Eatonton

32127

Progressive Medical Research, Port Orange

32720

Avail Clinical Research, LLC, DeLand

32806

Clinical NeuroScience Solutions Inc, Orlando

32940

Compass Research, Melbourne, Melbourne

33009

Velocity Clinical Research, Hallandale Beach, Hallandale

33134

Prestige Clinical Research Center, Inc., Coral Gables

33135

Suncoast Research Group, Miami

33161

Behavioral Clinical Research , Inc, North Miami

33409

Palm Beach Research Center, West Palm Beach

33458

Health Awareness inc., Jupiter

33461

Altus Research, Inc, Lake Worth

33462

JEM Research LLC, Atlantis

33604

Groupe Hospitalier Sud Hôpital Haut-Leveque Service d'hematologie, Pessac

33709

Meridien Research, St. Petersburg

35216

Achieve Clinical Research, LLC, Vestavia Hills

37203

Centennial Medical Center, Nashville

40536

University of Kentucky, Lexington

42055

CHU Saint Etienne Hopital Nord, Saint-Etienne

45212

CTI Clinical Trial and Consulting Services, Cincinnati

48202

Henry Ford Health Systems, Detroit

49503

Cherry Street Services, Inc., Grand Rapids

54511

Hôpital de Brabois Adultes, Vandœuvre-lès-Nancy

60637

The University Of Chicago Medicine, Chicago

60640

Great Lakes Clinical Trials, Chicago

67114

Heartland Research Associates, LLC, Newton

70121

Ochsner Clinic Foundation, New Orleans

70601

Centex Studies, Inc., Lake Charles

72211

Woodland International Research Group, Little Rock

73112

Lynn Health Science Institute, Oklahoma City

75014

Hopital Cochin, Paris

75571

Hopital Saint-Antoine, Paris

77058

Centex Studies, Inc., Houston

77073

Centex Studies, Inc., Houston

77081

Texas Center for Drug Development Inc, Houston

77598

Tranquility Clinical Research, Webster

78229

Endeavor Clinical Trials, LLC, San Antonio

78504

Centex Studies, Inc., McAllen

80020

IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S., Barranquilla

80033

Paradigm Clinical Research Centers, Inc., Wheat Ridge

81675

Klinikum rechts der Isar der TU Munchen, München

84107

JBR Clinical Research, Salt Lake City

85018

Hope Research Institute, Phoenix

85020

Central Phoenix Medical Clinic, Phoenix

85712

Quality of Life Medical & Research Center, LLC, Tucson

Synexus Clinical Research US Inc, Tucson

87102

Medpharmics, LLC, Albuquerque

90069

Anthony Mills Medical, Inc, Los Angeles

90703

Synexus Clinical Research US Inc, Cerritos

90806

Ark Clinical Research, Long Beach

91911

eStudySite, Chula Vista

92103

Artemis Institute for Clinical Research, San Diego

95684

Benchmark Research, Sacramento

470001

T Y C Inversiones S A S Grupsalud, Santa Marta

760042

Centro Medico Imbanaco de Cali S.A., Santiago de Cali

46617-2808

The South Bend Clinic Center for Research, South Bend

63110-1035

Washington University School Of Medicine, St Louis

08009

Hassman Research Institute, LLC., Berlin

07753

Jersey Shore University Medical Center, Neptune City

91350 200

Hospital Nossa Senhora da Conceicao S A, Porto Alegre

20221-160

Ministerio da Saude - Hospital dos Servidores do Estado - RJ, Rio de Janeiro

21040-900

Instituto Nacional de Infectologia Evandro Chagas (INI) - FIOCRUZ, Rio de Janeiro

01246-900

Instituto de infectologia Emilio Ribas, São Paulo

02141-000

Centro de Referencia E Treinamento Dst/Aids, São Paulo

Unknown

Fundacion Cardiomet CEQUIN, Armenia

Asistencia Cientifica de Alta Complejidad S.A.S, Bogotá

Leicester Royal Infirmary, Leicester

34295 cedex 05

CHU de Montpellier Hopital Saint Eloi, Montpellier

0002

VX Pharma, Pretoria

08916

Hosp. Univ. Germans Trias I Pujol, Badalona

08023

Hosp. Quiron Barcelona, Barcelona

08063

Hosp Clinic de Barcelona, Barcelona

B15 2GW

Queen Elizabeth Hospital, Birmingham

LD3 0UL

Powys Teaching Local Health Board - Bronllys Hospital, Brecon

BN2 5BE

Brighton & Sussex University Hospitals NHS Trust, Brighton

BS2 8HW

University Hospitals Bristol NHS Trust, Bristol

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust, Cambridge

DD1 9SY

Ninewells Hospital, Dundee

NW3 2QG

Royal Free Hospital, Hampstead

SE1 9RT

Guy's and St Thomas' Hospital, London

W2 1NY

Imperial College London and Imperial College Healthcare NHS Trust, London

M13 9WL

Central Manchester University Hospitals NHS Foundation Trust, Manchester

NE1 4LP

Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

OX3 7JX

University of Oxford, Oxford

PL6 8DH

Derriford Hospital, Plymouth

S10 2SB

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield

SO16 6YD

Southampton General Hospital, Southampton

All Listed Sponsors
lead

Janssen Vaccines & Prevention B.V.

INDUSTRY

NCT04614948 - A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults | Biotech Hunter | Biotech Hunter