Study to Evaluate Safety and Immunogenicity of Different Priming and Booster Regimens With Adjuvanted H5N8 and/or H5N6 Influenza Vaccine in Adults

PHASE2CompletedINTERVENTIONAL
Enrollment

480

Participants

Timeline

Start Date

June 7, 2023

Primary Completion Date

April 25, 2024

Study Completion Date

September 25, 2024

Conditions
Influenza, HumanInfectionsRespiratory Tract InfectionsVirus DiseasesInfection Viral
Interventions
BIOLOGICAL

aH5N8c on Day 1

MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N8 vaccine (aH5N8c) for intramuscular administration, containing intermediate dose H5N8 hemagglutinin + standard dose MF59 (approximately 0.5 mL total volume)

BIOLOGICAL

aH5N6c on Day 1

MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N6 vaccine (aH5N6c) for intramuscular administration, containing intermediate dose H5N6 hemagglutinin + standard dose MF59 (approximately 0.5 mL total volume)

BIOLOGICAL

aH5N8c on Day 22

MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N8 vaccine (aH5N8c) for intramuscular administration, containing intermediate dose H5N8 hemagglutinin + standard dose MF59 (approximately 0.5 mL total volume)

BIOLOGICAL

aH5N6c on Day 22

MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N6 vaccine (aH5N6c) for intramuscular administration, containing intermediate dose H5N6 hemagglutinin + standard dose MF59 (approximately 0.5 mL total volume)

BIOLOGICAL

aH5N8c on Day 202

MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N8 vaccine (aH5N8c) for intramuscular administration, containing intermediate dose H5N8 hemagglutinin + standard dose MF59 (approximately 0.5 mL total volume)

Trial Locations (9)

30047

Lifeline Primary Care, Lilburn

30092

Georgia Clinic, Norcross

35055

Cullman Clinical Trials, Cullman

37643

Medical Care LLC, Elizabethton

51106

Velocity Clinical Research, Sioux City

68701

Velocity Clinical Research, Norfolk

68803

Velocity Clinical Research, Grand Island

70809

Velocity Clinical Research, Baton Rouge

84010

Cope Family Medicine, Bountiful

All Listed Sponsors
collaborator

Biomedical Advanced Research and Development Authority

FED

lead

Seqirus

INDUSTRY

NCT05874713 - Study to Evaluate Safety and Immunogenicity of Different Priming and Booster Regimens With Adjuvanted H5N8 and/or H5N6 Influenza Vaccine in Adults | Biotech Hunter | Biotech Hunter