A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

660

Participants

Timeline

Start Date

September 7, 2023

Primary Completion Date

November 15, 2023

Study Completion Date

May 20, 2024

Conditions
COVID-19
Interventions
BIOLOGICAL

XBB.1.5 Vaccine (Booster)

Omicron sub variant XBB.1.5 SARS-CoV-2 rS /Matrix-M Adjuvant the monovalent \[5 μg/50 μg\] NVX-CoV2601) XBB.1.5 Vaccine (Booster)

BIOLOGICAL

XBB.1.5 Vaccine (single dose)

Omicron sub variant XBB.1.5 SARS-CoV-2 rS /Matrix-M Adjuvant the monovalent \[5 μg/50 μg\] NVX-CoV2601) XBB.1.5 Vaccine ( single dose)

Trial Locations (30)

14609

Rochester Clinical Research, Rochester

19147

DM Clinical Research, Philadelphia

21201

University of Maryland, Baltimore

23606

Health Research of Hampton Roads, Newport News

30046

Tekton Research, Lawrenceville

33134

AMR LLC-Miami, Coral Gables

33458

Health Awareness,LLC, Jupiter

33912

AMR, Fort Myers

36608

AMR, Mobile

37909

AMR, Knoxville

63141

Sundance Clinical Research, St Louis

64114

AMR, Kansas City

67114

Alliance for Multispecialty RSCH, Newton

67218

Tekton Research, Wichita

68701

Velocity Clinical Research, Norfolk

70119

AMR New Orleans, New Orleans

73099

Tekton Research, Yukon

75093

Research For Your Health, Plano

76135

Benchmark Research, Fort Worth

77706

Tekton Research, Beaumont

78229

Tekton Research, San Antonio

78520

Pan American clinical Research,LLC, Brownsville

78705

Benchmark Research, Austin

78745

Tekton Research, Austin

80918

Lynn Institute of the Rockies, Colorado Springs

84041

AMR Layton Research Centre, Layton

87109

AXCES Research, Albuquerque

89119

AMR, Las Vegas

95864

Benchmark Research, Sacramento

98104

University of Washington, Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novavax

INDUSTRY