33,000
Participants
Start Date
December 27, 2020
Primary Completion Date
April 10, 2023
Study Completion Date
December 15, 2023
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Days 0 and 21 in Initial Vaccination Period.
Placebo (Initial Vaccination Period)
Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21 in Initial Vaccination Period.
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period)
In Crossover Vaccination period, one dose of intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Day 0 or Day 21
Placebo (Crossover Vaccination period)
In Crossover Vaccination period, one dose of intramuscular (deltoid) injection of placebo (0.5 mL) on Day 0 or Day 21
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)
In Booster Vaccination period, one dose of intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Day 0
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Second Booster Vaccination)
In Second Booster Vaccination period, one dose of intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Day 0
Weill Cornell Chelsea CRS (Adult Site), New York
Stony Brook Responder Vaccine Program (Adult Site), Commack
Meridian Clinical Research (Pediatric Site), Binghamton
Rochester Clinical Research (Pediatric & Adult Site), Rochester
Preferred Primary Care Physicians, Inc. (Pediatric Site), Pittsburgh
Meridian Clinical Research (Pediatric Site), Washington D.C.
Howard University Hospital Howard/ University College of Medicine (Adult Site), Washington D.C.
c/o The Pediatric Center of Frederick LLC (Adult & Pediatric Site), Baltimore
Pediatric Research of Charlottesville, LLC (Pediatric Site), Charlottesville
Health Research of Hampton Roads, Inc (Pediatric & Adult Site), Newport News
Wake Forest Health Network - Pediatrics - Ford, Simpson, Lively & Rice (Pediatric Site), Salem
M3 Wake Research, Inc (Adult Site), Raleigh
M3-Emerging Medical Research, LLC (Pediatric & Adult Site), Durham
PMG Research of Rocky Mount, LLC (Adult Site), Rocky Mount
The Charlotte-Mecklenburg Hospital Authority d/b/a Atrium Health (Pediatric & Adult Site), Charlotte
Carolina Institute for Clinical Research (Adult Site), Fayetteville
Carolina Institute for Clinical Research (Adult Site), Fayetteville
Womack Army Medical Center (Adult Site), Fort Bragg
PMG Research of Wilmington, LLC (Adult Site), Wilmington
Spartanburg Medical Research (Pediatric Site), Spartanburg
Coastal Carolina Research Center (Pediatric Site), North Charleston
Medical University of South Carolina, SCTR Research Nexus (Adult Site), Charleston
Synexus Clinical Research US, Inc. (Adult Site), Anderson
Clinical Research Atlanta (Adult Site), Stockbridge
Emory University Hospital (Adult Site), Atlanta
Synexus Clinical Research US, Inc. (Adult Site), Atlanta
Atlanta Center for Medical Research (Adult Site), Atlanta
Tekton Research, Inc. (Pediatric Site), Chamblee
Columbus Regional Research Institute (Adult Site), Columbus
Synexus Clinical Research US, Inc. (Adult Site), The Villages
Jacksonville Center for Clinical Research (Pediatric & Adult Site), Jacksonville
SIMED Health, LLC / SIMED Research (Adult Site), Gainesville
University Clinical Research-Deland, LLC dba Accel Research Sites (Pediatric & Adult Site), DeLand
Clinical Neuroscience Solutions Inc (Pediatric & Adult Site), Orlando
Headlands Research Orlando (Adult Site), Orlando
M D Clinical (Adult Site), Hallandale
Miami Veterans Affairs Medical Center (Adult Site), Miami
Suncoast Research Associates, LLC (Adult Site), Miami
Acevedo Clinical Research Associates (Pediatric Site), Miami
Suncoast Research Associates, LLC (Adult Site), Miami
Comprehensive Clinical Trials, Llc (Pediatric & Adult site), West Palm Beach
Tampa Heart & Cardiovascular Center (Adult Site), Tampa
Office Of John S. Curran MD (Adult Site), Tampa
Synexus Clinical Research US, Inc (Adult Site), Pinellas Park
Meridien Research/Accel Research (Pediatric & Adult site), Lakeland
Asclepes Research Centers (Adult & Pediatric Site), Spring Hill
Alabama Clinical Therapeutics, Llc (Pediatric Site), Birmingham
Accel Research Sites (Adult Site), Birmingham
Central Research Associates, Inc (Pediatric Site), Birmingham
Clinical Research Associates (Pediatric Site), Nashville
Clinical and Translational Research Center at Meharry Medical College (Adult Site), Nashville
WR Clinsearch, LLC (Pediatric & Adult Site), Chattanooga
Accellacare of Bristol (Pediatric & Adult Site), Bristol
Holston Medical Group (Pediatric Site), Kingsport
Accellacare US Inc., d/b/a Accellacare of Knoxville (Adult Site), Knoxville
Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare (Pediatric & Adult Site), Memphis
MedPharmics, LLC-Biloxi (Pediatric & Adult Site), Gulfport
Kentucky Pediatric/Adult Research (Pediatric Site), Bardstown
Brownsboro Park Pediatrics (Pediatric Site), Louisville
Aventiv Research Inc (Pediatric Site), Columbus
Dr. Shelly David Senders MD Inc. dba Senders Pediatrics (Pediatric Site), Cleveland
Velocity Clinical Research (Pediatric & Adult Site), Cleveland
Synexus Clinical Research, US, Inc. (Adult Site), Akron
PanAmerican Clinical Research Mexico S.A de C.V (Adult Site), Guadalajara
Sterling Research Group, Ltd. (Adult Site), Cincinnati
Synexus Clinical Research US, Inc. (Adult Site), Cincinnati
Sterling Research Group, Ltd (Pediatric & Adult Site), Cincinnati
Buynak Clinical Research, P.C. (Pediatric & Adult Site), Valparaiso
Synexus USA (Adult Site), Evansville
VA Ann Arbor Healthcare System (Adult Site), Ann Arbor
Wayne State University/ Children's Hospital of Michigan (Adult Site), Detroit
Meridian Clinical Research (Adult Site), Sioux City
The University of Iowa Hospitals & Clinics (Adult Site), Iowa City
Synexus Clinical Research US, Inc. (Adult Site), Richfield
University of Minnesota (Adult Site), Minneapolis
American Indian Clinical Trials Research Network (Pediatric & Adult Site), Eagle Butte
Synexus Clinical Research US, Inc (Adult Site), Chicago
Cedar Crosse Research Center (Adult Site), Chicago
Providea Health Partners LLC (Adult Site), Evergreen Park
Instituto Nacional de Salud Publica (INSP) - Cuernavaca - Centro de Investigacion en Salud Poblacional (CISP) (Adult Site), Cuernavaca
Sundance Clinical Research, LLC (Pediatric & Adult Site), St Louis
The Curators of University of Missouri (Adult Site), Columbia
Johnson County Clin-Trials, Inc. (Pediatric & Adult Site), Lenexa
Alliance for Multispecialty Research (AMR) (Pediatric Site), Newton
AMR Wichita East (Formerly Heartland Research Associates) (Pediatric SIte), Wichita
Meridian Clinical Research Associates, LLC (Pediatric & Adult Site), Omaha
University Of Nebraska Medical Center (Pediatric & Adult Site), Omaha
Meridian Clinical Research (Adult & Pediatric Site), Norfolk
Med Pharmics, LLC (Pediatric & Adult Site), Metairie
Meridian Clinical Research Baton Rouge (Pediatric Site), Baton Rouge
Meridian Clinical Research, LLC (Adult Site), Baton Rouge
Willis-Knighton Physician Network (Adult Site), Shreveport
Lynn Institute of the Ozarks (Adult Site), Little Rock
Preferred Research Partners, Inc. (Adult Site), Little Rock
Medical Research International (Adult Site), Oklahoma City
Lynn Health Science Institute (Pediatric & Adult Site), Oklahoma City
Research Your Health (Pediatric & Adult site), Plano
Ventavia Research Group, LLC (Pediatric Site), Fort Worth
Benchmark Research (Pediatric & Adult Site), Fort Worth
PanAmerican Clinical Research Mexico (Adult Site), Juriquilla
Ventavia Research Group, LLC (Pediatric Site), Houston
Baylor College of Medicine (Adult Site), Houston
DM Clinical Research - Pediatric Healthcare of NW Houston, P.A. (Pediatric Site), Houston
Texas Center for Drug Development, Inc (Pediatric & Adult Site), Houston
DM Clinical Research (Pediatric & Adult Site), Tomball
The University Of Texas Medical Branch (Utmb) (Pediatric Site), League City
AES San Antonio (Adult Site), San Antonio
University of Texas Health Science Center San Antonio (Adult Site), San Antonio
Tekton Research, Inc. (Pediatric Site), San Antonio
Centex Studies, Inc (Adult Site), McAllen
Benchmark Research (Pediatric & Adult Site), Austin
University of Colorado Clinical and Translational Research Centers (Pediatric & Adult Site), Aurora
Lynn Institute of the Rockies (Adult Site), Colorado Springs
Advanced Clinical Research (Pediatric & Adult Site), Meridian
Wee Care Pediatrics (Pediatric Site), Layton
Wee Care Pediatrics (Pediatric Site), Syracuse
Advanced Clinical Research (Adult Site), West Jordan
The Pain Center of Arizona (Adult Site), Phoenix
Foothills Research Center-CCT Research (Pediatric Site), Phoenix
Alliance for Multispecialty Research, LLC (Adult Site), Tempe
Clinical Research Center of Nevada (Pediatric Site), Las Vegas
Synexus Clinical Research US, Inc. (Adult Site), Henderson
Clinical Research Consortium (Adult Site), Las Vegas
National Research Institute (Pediatric & Adult Site), Los Angeles
Premier Health Research Center, Llc (Pediatric Site), Downey
Coast Clinical Research, LLC (Pediatric Site), Bellflower
WR-PRI, LLC (Adult Site), Los Alamitos
Orange County Research Institute (Pediatric Site), Ontario
Empire Clinical Research (Pediatric & Adult Site), Pomona
FAICIC S. DE R.L. DE C.V. (Adult Site), Veracruz
Velocity Clinical Research (Pediatric & Adult Site), Chula Vista
eStudySite - Corporate Offices (Adult Site), La Mesa
Synexus Clinical Research US, Inc. (Adult Site), Vista
Paradigm Clinical Research Centers, Inc (Pediatric Site), La Mesa
California Research Foundation (Pediatric & Adult Site), San Diego
Advanced Clinical Research - Rancho Paseo (Pediatric & Adult Site), Banning
Anaheim Clinical Trials (Adult Site), Anaheim
Dignity Health Medical Foundation - Woodland (Adult Site), Woodland
University of California Davis Health (Pediatric & Adult Site), Sacramento
Benchmark Research (Pediatric & Adult Site), Sacramento
Unidad de Atencion Medica e Investigacion en Salud (UNAMIS) (Adult Site), Mérida
Velocity Clinical Research (Pediatric & Adult Site), Medford
University of Washington VTEU (Adult Site), Seattle
MultiCare Institute for Research & Innovation (Adult Site), Cheney
Atlanta - Morehouse School of Medicine (Adult Site), Atlanta
Beth Israel Deaconess Medical Center (Adult Site), Boston
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill (Pediatric & Adult Site), Chapel Hill
The Miriam Hospital (TMH) (Adult Site), Providence
Omega Medical Research, Providence (Pediatric & Adult Site), Warwick
CAIMED Investigacion en Salud S.A de C.V (Adult Site), Mexico City
Caimed Investigacion en Salud S.A. de C.V. (Adult Site), Mexico City
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Adult Site), Mexico City
Ponce Medical School Foundation Inc. / CAIMED Cneter (Pediatric & Adult Site), Ponce
University of Puerto Rico Medical Sciences Campus Maternal Infant Studies Center (Adult Site), San Juan
Lead Sponsor
Department of Health and Human Services
FED
Novavax
INDUSTRY