A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age

PHASE3CompletedINTERVENTIONAL
Enrollment

3,196

Participants

Timeline

Start Date

July 11, 2016

Primary Completion Date

October 4, 2017

Study Completion Date

October 4, 2017

Conditions
Avian Influenza
Interventions
BIOLOGICAL

aH5N1c

Intramuscular (IM) administration, containing 7.5 mcg H5N1 hemagglutinin antigen (HA) + 0.25 mL MF59 (approximately 0.5 mL total volume).

BIOLOGICAL

Placebo

Placebo: Saline injection

Trial Locations (26)

13901

RCR/United Medical Associates, PC, Binghamton

14609

Rochester Clinical Research, Inc, Rochester

20850

Optimal Research, LLC, Rockville

27609

PMG Research of Winston-Salem, Winston-Salem

29303

Spartanburg Medical Research, Spartanburg

29407

Medical Research South, Charleston

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

PMG Research of Raleigh, Raleigh

61614

Optimal Research, Peoria

63141

Sundance Clinical Research, LLC, St Louis

64114

The Center for Pharmaceutical Research, Kansas City

67207

Heartland Research Associates, 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, Salt Lake City

84121

J. Lewis Research, Inc. / FirstMed East, Salt Lake City

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

85224

Radiant Research, Chandler

85283

Clinical Research Consortium Arizona, Tempe

92108

Optimal Research Site, San Diego

92123

California Research Foundation, San Diego

06460

Clinical Research Consulting, LLC, Milford

All Listed Sponsors
collaborator

Biomedical Advanced Research and Development Authority

FED

lead

Seqirus

INDUSTRY

NCT02839330 - A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age | Biotech Hunter | Biotech Hunter