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

Summary

This is a Phase II open-label study in approximately 200, and up to 240, healthy males and non-pregnant females, aged 18 years and older. This study is designed to assess the safety, reactogenicity, and immunogenicity of an unadjuvanted subvirion monovalent inactivated influenza H3N2v vaccine manufactured by Sanofi Pasteur. 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 vaccine, delivered intramuscularly as 15mcg HA/0.5mL dose, 21 days apart. The duration of the study for each subject will be approximately 7 months.

Timeline

Start

2013-01

Primary completion

2013-08

Completion

2013-08

Publications

• Keitel WA, Jackson LA, Edupuganti S, Winokur PL, Mulligan MJ, Thornburg NJ, Patel SM, Rouphael NG, Lai L, Bangaru S, McNeal MM, Bellamy AR, Hill HR; VTEU H3N2v Vaccine Study Work Group. Safety and Immunogenicity of a Subvirion Monovalent Unadjuvanted Inactivated Influenza A(H3N2) Variant Vaccine in Healthy Persons >/=18 Years Old. J Infect Dis. 2015 Aug 15;212(4):552-61. doi: 10.1093/infdis/jiv056. Epub 2015 Feb 3.

Drugs

Indications