BARDA BP-I-23-001 H5 Influenza

PHASE2CompletedINTERVENTIONAL
Enrollment

1,380

Participants

Timeline

Start Date

August 21, 2024

Primary Completion Date

January 2, 2025

Study Completion Date

June 11, 2025

Conditions
Influenza
Interventions
BIOLOGICAL

3.75 µg H5N8 antigen plus full dose AS03A

Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.

BIOLOGICAL

7.5 µg H5N8 antigen plus full dose AS03A

Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.

BIOLOGICAL

15 µg H5N8 antigen plus full dose AS03A

Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.

BIOLOGICAL

3.75 µg H5N8 antigen plus half dose AS03A

Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.

BIOLOGICAL

7.5 µg H5N8 antigen plus half dose AS03A

Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.

BIOLOGICAL

15 µg H5N8 antigen plus half dose AS03A

Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.

BIOLOGICAL

3.75 µg H5N8 antigen plus MF59

Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.

BIOLOGICAL

7.5 µg H5N8 antigen plus MF59

Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.

BIOLOGICAL

15 µg H5N8 antigen plus MF59

Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.

BIOLOGICAL

3.75 µg H5N1 antigen plus full dose AS03A

Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.

BIOLOGICAL

7.5 µg H5N1 antigen plus full dose AS03A

Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.

BIOLOGICAL

15 µg H5N1 antigen plus full dose AS03A

Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.

Trial Locations (20)

14609

Rochester Clinical Research, New York

20166

DelRicht Research - Virgina, Sterling

27518

Accellacare - Cary, Cary

28401

Accellacare - Tradd Court, Wilmington

28601

Accellacare of Hickory, Hickory

28625

Accellacare - Piedmont Healthcare, Statesville

30329

DelRicht Research - Atlanta, Atlanta

31406

Javara Research - Privia Medical Group Georgia, Savannah

40509

Alliance for Multispecialty Research - Lexington, Lexington

45212

CTI Clinical Research Center, Cincinnati

60453

Accellacare - Duly Health and Care - Oak Lawn, Oak Lawn

66219

Johnson County Clin-Trials (JCCT), Lenexa

67207

Alliance for Multispecialty Research - Wichita East - Heartland Research Associates, Wichita

70115

DelRicht Research - New Orleans - Prytania Street, New Orleans

70769

DelRicht Research - Prairieville, Prairieville

73099

Tekton Research - Oklahoma - Primary Health Partners, Yukon

74133

DelRicht Research - Tulsa, Tulsa

77384

Javara Research - Privia Medical Group Gulf Coast, Conroe

78229

Tekton Research - San Antonio, San Antonio

78745

Tekton Research - Austin, Austin

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Rho Federal Systems Division, Inc.

INDUSTRY

collaborator

ICON plc

INDUSTRY

lead

Biomedical Advanced Research and Development Authority

FED