Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection

Summary

The purpose of this study is to demonstrate the efficacy of an investigational Vero cell-derived, trivalent, seasonal influenza vaccine to prevent infection with an influenza virus that is antigenically similar to one of the three strains in the vaccine. Subjects will be randomized in a double-blind fashion to receive a single intramuscular injection of either the investigational vaccine or placebo. Blood will be drawn from all subjects for a determination of hemagglutination inhibition antibody titers on Days 0 and 21, body temperature and injection site reactions will be monitored daily for 7 days. In addition, subjects must return to the clinic promptly to have swab samples of their nose and throat taken whenever they feel flu symptoms and all subjects will be monitored for adverse events until Day 180.

Timeline

Start

2008-12

Primary completion

2009-05

Completion

2009-06

Drugs

Indications