994
Participants
Start Date
October 16, 2023
Primary Completion Date
May 21, 2024
Study Completion Date
May 21, 2024
NVX-CoV2373 (5μg)
Coformulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 μg/mL and 100 μg adjuvant per mL, respectively
NVX-CoV2601 (5μg)
The vaccination regimen will comprise one IM injection on Day 0 at a dose of 5 µg of antigen with 50 µg Matrix-M adjuvant.
NVX-CoV2601(5μg)
The vaccination regimen will comprise one IM injection on Day 0 at a dose of 5 µg of antigen with 75 µg Matrix-M adjuvant.
NVX-CoV2601 (35μg)
The vaccination regimen will comprise one IM injection on Day 0 at a dose of 35 µg of antigen with 50 µg Matrix-M adjuvant.
NVX-CoV2601(35μg)
The vaccination regimen will comprise one IM injection on Day 0 at a dose of 35 µg of antigen with 75 µg Matrix-M adjuvant.
NVX-CoV2601(50μg)
The vaccination regimen will comprise one IM injection on Day 0 at a dose of 50 µg of antigen with 100 µg Matrix-M adjuvant
Bivalent BA.4/5
The bivalent BA.4/5 (or recommended mRNA vaccine at the time of the conduct of this study) Omicron subvariant/prototype licensed mRNA vaccine will be procured and stored per the manufacturer's instructions. For this vaccine group, treatment will be administered open label as a single IM injection
Velocity Clinical Research, Binghamton
Clinical Research Partners, Richmond
Health Research of Hampton Roads, Inc, Newport News
Javara Inc./Wake Forest Health Network, LLC, Winston-Salem
M3 Wake Research Inc, Raleigh
Trial Management Associates, LLC, Wilmington
Hypercore (Lucas Research), New Bern
Velocity Clinical Research, Gaffney, Gaffney
Coastal Carolina Research Center an ALCANZA Clinical Research company, North Charleston
Neurostudies CRU, Decatur
CRA Headlands LLC, Stockbridge
Velocity Clinical Research, Savannah
Wr-Msra, Llc, Lake City
Deland CRU, DeLand
Headlands Research Orlando LLC, Orlando
Research Institute of South Florida, Miami
Suncoast Research Associates, LLC, Miami
Precision Clinical Research, LLC, Sunrise
Health Awareness, Jupiter
TrueBlue Clinical Research, Tampa
Professional Urgent Care Services, Largo
ARS-Birmingham CRU, Birmingham
Velocity Clinical Research, Gulfport, Gulfport
Velocity Clinical Research, Cincinnati
Velocity Clinical Research, Cincinnati
Velocity Clinical Research, Sioux City
Velocity Clinical Research, Omaha
Velocity Clinical Research, Norfolk
Velocity Clinical Research, Grand Island
Velocity Clinical Research, Metairie, Metairie
Velocity Clinical Research - Covington, Covington
Velocity Clinical Research, Baton Rouge
Tekton Research, Edmond
Lynn Health Science Institute, Oklahoma City
Research Your Health, Plano
Benchmark Research, San Angelo
Central Texas Clinical Research, LLC, Austin
Velocity Clinical Research, Meridian
Velocity Clinical Research, Salt Lake City, West Jordan
Tucson Neuroscience Research, Tucson
Velocity Clinical Research, Chula Vista, Chula Vista
Velocity Clinical Research, San Diego, La Mesa
Artemis - San Diego, San Diego
WR-MCCR, San Diego
Artemis Institute for Clinical Research, Riverside
Velocity Clinical Research, Grants Pass, Grants Pass
Velocity Clinical Research, Banning, Banning
Activmed Practices and Research, LLC, Methuen
Activmed Practices and Research, LLC, Portsmouth
Velocity Clinical Research, Providence, East Greenwich
Lead Sponsor
Novavax
INDUSTRY