Safety and Immunogenicity of a Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine in Adult and Elderly Populations

PHASE2CompletedINTERVENTIONAL
Enrollment

211

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

August 31, 2013

Study Completion Date

August 31, 2013

Conditions
Influenza
Interventions
BIOLOGICAL

Influenza A/H3N2 variant Vaccine

Investigational influenza virus H3N2v vaccine, a monovalent type A inactivated vaccine (H3N2v MIV) for intramuscular use, is a sterile clear and slightly opalescent suspension prepared from influenza virus propagated in embryonated chicken eggs. The H3N2v MIV contains no preservative. Subjects will be stratified by age (approximately 100 (up to 120) subjects 18-64 years old and approximately 100 (up to 120) subjects \>/=65 years old) to receive two doses of H3N2v MIV, delivered intramuscularly as 15 micrograms (mcg) of hemagglutinin (HA)/0.5 milliliter (mL) dose, 21 days apart

Trial Locations (4)

30030-1705

Emory Vaccine Center - The Hope Clinic, Decatur

52242-1009

University of Iowa - Infectious Disease Clinic, Iowa City

77030-3411

Baylor College of Medicine - Molecular Virology and Microbiology, Houston

98101-1466

Group Health Research Institute - Seattle, Seattle

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01746082 - Safety and Immunogenicity of a Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine in Adult and Elderly Populations | Biotech Hunter | Biotech Hunter