NCT00800605

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

Double Blind, Placebo Controlled Phase 3 Study of the Efficacy of an Investigational Vero Cell-Derived Influenza Vaccine to Prevent Culture Confirmed Influenza Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7,250 (actual)
• Sponsor: Alachua Government Services, Inc. · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Vero cell-derived, trivalent, seasonal influenza vaccine	Single intramuscular injection
BIOLOGICAL	Placebo: Phosphate-buffered saline	Single intramuscular injection

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-05-01
• Completion: 2009-06-01
• First posted: 2008-12-02
• Last updated: 2025-11-24
• Results posted: 2025-11-24

Locations

36 sites across 1 country: United States