400
Participants
Start Date
August 16, 2023
Primary Completion Date
April 1, 2024
Study Completion Date
September 30, 2024
NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine
Coformulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 µg antigen and 100 µg adjuvant per mL. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg antigen with 50 µg Matrix-M adjuvant.
Prototype/XBB.1.5 Bivalent Vaccine (5 µg)
A site-mixed bivalent vaccine prepared by combining 0.25 mL of NVX-CoV2373 and 0.25 mL NVX-CoV2601. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg total antigen (2.5 µg prototype antigen + 2.5 µg Omicron XBB.1.5 antigen) with 50 µg Matrix-M adjuvant.
Velocity Clinical Research, Vestal
Westside Center for Clinical Research, Jacksonville
Alfa Medical Research, Davie
ITB Research, Miami
Clinical Research Associates, Inc, Nashville
Velocity Clinical Research, Cincinnati
DM Clinical Research - Chicago, River Forest
Johnson County Clinical Trials, Lenexa
Alliance for Multispecialty Research, LLC (AMR), Newton
AMR, Wichita
Velocity Clinical Research, Lafayette
Tekton Research, Tulsa
Research Your Health, Plano
DM Clinical Research, Houston
Medical Colleagues of Texas, LLP, Katy
Tekton Research, San Antonio
South Texas Clinical Research, Corpus Christi
Benchmark Research, Austin
Velocity Clinical Research, Meridian
Mountain View CCT Research, Pleasant View
Lead Sponsor
Novavax
INDUSTRY