A Study to Evaluate Safety and Immunogenicity of One or Two Booster Vaccinations With H5N6 Influenza Vaccine in Adults Primed With H5N1 Influenza Vaccine or Unprimed

PHASE2CompletedINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

July 18, 2022

Primary Completion Date

October 24, 2022

Study Completion Date

March 24, 2023

Conditions
Influenza, HumanInfluenza in BirdsRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases
Interventions
BIOLOGICAL

aH5N6c on Day 1

MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N6 vaccine (aH5N6c) for intramuscular (IM) administration, containing 7.5 μg H5N6 hemagglutinin (HA) (A/Guangdong/18SF020/2018 (H5N6)-like) + 0.25 mL 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 (IM) administration, containing 7.5 μg H5N6 HA (A/Guangdong/18SF020/2018 (H5N6)-like) + 0.25 mL MF59 (approximately 0.5 mL total volume) given 3 weeks after the first aH5N6c vaccination

BIOLOGICAL

Placebo on Day 22

Saline placebo (sterile, 0.5 mL) given 3 weeks after the aH5N6c vaccination

Trial Locations (18)

14609

Rochester Clinical Research, Inc, Rochester

27103

AccellaCare, Winston-Salem

27609

PMG Research of Raleigh, Raleigh

32934

Optimal Research, LLC, Melbourne

33756

Innovative Research of West Florida, Inc., Clearwater

35802

Optimal Research, LLC, Huntsville

43213

Aventiv Research, Columbus

60640

Great Lakes Clinical Trials LLC, Chicago

63141

Sundance Clinical Research, LLC, St Louis

64114

The Center for Pharmaceutical Research, Kansas City

67207

Heartland Research Associates, LLC, Wichita

78229

Biogenics Research Institute, San Antonio

84095

J. Lewis Research, Inc/Jordan River Family Medicine, South Jordan

84109

J. Lewis Research, Inc/Foothill Family Clinic North, Salt Lake City

84121

J. Lewis Research, Inc/Foothill Family Clinic South, Salt Lake City

85283

Clinical Research Consortium Arizona, Tempe

92103

California Research Foundation, San Diego

06460

Clinical Research Consulting, LLC, Milford

All Listed Sponsors
lead

Seqirus

INDUSTRY