Study of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

30,918

Participants

Timeline

Start Date

November 19, 2020

Primary Completion Date

August 25, 2021

Study Completion Date

April 30, 2022

Conditions
SARS-CoV-2 Infection
Interventions
DRUG

Intramuscular injection

Subjects will receive two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once)

BIOLOGICAL

Intramuscular vaccine

Subjects will receive two doses of 3.75 µg of CoVLP adjuvanted with AS03 adjuvant given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once)

Trial Locations (91)

3100

RM Pharma Specialists S.A. de C.V., Mexico City

5000

Sanatorio Allende, Córdoba

13760

Meridian Clinical Research, Endwell

20010

Investigación Biomédica para el Desarrollo de Fármacos, S.A. de C.V., Aguascalientes

20017

Ascension Providence Health System, Washington D.C.

27612

M3 Wake Research, Inc, Raleigh

28303

Carolina Institute for Clinical Research, Fayetteville

28403

Trial Management Associates LLC, Wilmington

31406

Meridian Clinical Research, Savannah

33024

Research Centers of America, Hollywood

33155

AppleMed Research Inc, Miami

33351

Precision Clinical Research, Sunrise

33410

Elixia COVID-19, Palm Beach

35216

Achieve Clinical Research, LLC dba Accel Research Sites, Birmingham

43213

Aventiv Research Inc, Columbus

44122

Velocity Clinical Research, Cleveland

45070

Investigación Biomédica para el Desarrollo de Fármacos, S.A. de C.V., Zapopan

45242

Velocity Clinical Research - Cincinnati, Cincinnati

48236

Ascension St. John Vaccine Research Unit, Grosse Pointe Woods

51106

Meridian Clinical Research, Sioux City

60644

Affinity Health, Chicago

68130

Methodist Physicians, Fremont

68134

Meridian Clinical Research LLC, Omaha

68516

Be Well Clinical Studies, LLC, Lincoln

68701

Meridian Clinical Research LLC, Norfolk

70433

Benchmark Research, Covington

72410

Integra RGH Centro de Investigacion, Clinica de Ozonoterapia RGH AC, Puebla City

75093

Research Your Health, Plano

75224

Global Medical Research, Dallas

76135

Benchmark Research, Fort Worth

77375

DM Clinical Research/Martin Diagnostic Clinic, Tomball

77479

Mt. Olympus Medical Research, LLC, Sugar Land

Sugar Lakes Family Practice, Sugar Land

78705

Benchmark Research, Austin

78745

Tekton Research, Austin

80230

Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C., Culiacán

83687

ASR, LLC, Nampa

84088

Advanced Clinical Research, Inc., West Jordan

84405

South Ogden Family Medicine, Ogden

85283

Fiel Family and Sports Medicine/CCT, Tempe

89030

Las Vegas Clinical Trials, North Las Vegas

89103

Forte Family Practice/ CCT Research, Las Vegas

89109

Excel Clinical Research, Las Vegas

91303

Hope Clinical Research, Canoga Park

91900

Sociedad de Metabolismo y Corazon S.C (SOMECO), Veracruz

92108

Wr-McCr, Llc, San Diego

92660

Pharmacology Research Institute, Newport Beach

92845

CNS Network, Garden Grove

97130

Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica en Yucatan S.C.P. (CEMDEICY S.C.P.), Mérida

90806-3221

Long Beach Clinical Trial Services Inc., Long Beach

33134-4321

Alliance for Multispecialty Research, Coral Gables

08009

Hassman Research Institute, Berlin

02886

Velocity Clinical Research Providence, Warwick

C1128AAF

Mautalen Salud e Investigación (Expertia SA), Buenos Aires

C1405BOA

Fundación FunDaMos, Buenos Aires

C1426

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich, Buenos Aires

T4000

Clinica Mayo de UMCB SRL, San Miguel de Tucumán

70200-730

Instituto de Pesquisas Clinicas L2IP, Brasília

83606-177

Unidade Hospital do Rocio, Campo Largo

30150-221

Santa Casa De Misericordia De Belo Horizonte, Minas Gerais

90035-001

Centro de Pesquisa Clinica - Hospital Moinhos de Vento, Porto Alegre

20241-180

IBPClin Instituto Brasil de Pequisa Clinica, Rio de Janeiro

15090-000

Fundação Faculdade Regional de Medicina de Sao Jose do Rio Preto, São Paulo

13271-130

Azidus Brasil Pesquisa e Desenvolvimento Ltda, Valinhos

T4N 6V7

CARe Clinic, Red Deer

B3K 6R8

IWK Health Centre- Dalhousie University-Canadian Center for Vaccinology, Halifax

L6T 0G1

Aggarwal and Associates Ltd, Brampton

N1H 1B1

Dawson Clinical Research Inc., Guelph

L3Y 5G8

SKDS Research Inc., Newmarket

M4G 3E8

LMC Clinical Research Inc. (CPU), Toronto

M9W 4L6

Manna Research Toronto, Toronto

G6W OM5

Manna Research (Quebec), Lévis

J7J 2K8

Manna Research (Mirabel), Mirabel

H9H 4Y6

McGill University Health Centre Vaccine Study Centre, Pierrefonds

G1E 7G9

CHU de Québec-Université Laval, Québec

G1N 4V3

Diex Research Quebec Inc., Québec

J6E 2B4

Diex Recherche Joliette, Saint-Charles-Borromée

J1J 2G2

Q&T Research Sherbrooke Inc., Sherbrooke

J1L 0H8

Diex Recherche Sherbrooke, Sherbrooke

AB25 2ZD

NHS Grampian, Aberdeen

B15 2SQ

Synexus Midlands Clinical Research Centre, Birmingham

BH7 7DW

University Hospital Southampton NHS Foundation Trust (UHS), Bournemouth

CF10 4BZ

Public Health Wales, Cardiff

CF15 9SS

Synexus Wales DRS, Cardiff

CM17ET

Mid and South Essex NHS Foundation Trust, Chelmsford

PR7 7 NA

Synexus Lancashire DRS, Chorley

DE22 3NE

University Hospitals Derby and Burton, Derby

HA1 3UJ

London North West University Healthcare NHS Trust, Harrow

SE5 9PJ

Kings College Hospital, London

M15 6SE

Synexus Manchester DRS, Manchester

YO31 8HE

University of York/York Teaching Hospital, York

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medicago

INDUSTRY

NCT04636697 - Study of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults | Biotech Hunter | Biotech Hunter