NCT00782431

Immunogenicity and Safety Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) in Adults Aged 50 Years and Older

Phase 3 Double Blind Clinical Study of Effectiveness and Safety of Vero Cell-Derived, Trivalent, Seasonal Influenza Vaccine in Adults Aged 50 Years and Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,208 (actual)
• Sponsor: Alachua Government Services, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to demonstrate the effectiveness (seroprotection and seroconversion as measured by the hemagglutination inhibition \[HI\] assay) of an investigational Vero cell-derived, trivalent, seasonal influenza vaccine in adults 50 years of age and older. Subjects will be randomized in a double-blind fashion to receive a single intramuscular injection of either the investigational vaccine or a licensed egg-derived seasonal influenza vaccine. Blood will be drawn from all subjects for a determination of HI antibody titers on Days 0 and 21, body temperature and injection site reactions will be monitored daily for 7 days. In addition, subjects will be monitored for adverse events and rises in body temperature until Day 21 and again until Day 180.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Vero cell derived, trivalent, seasonal influenza vaccine	Single intramuscular injection
BIOLOGICAL	Licensed egg-derived, trivalent seasonal influenza vaccine	Single intramuscular injection

Timeline

• Start date: 2008-11-01
• Primary completion: 2008-12-01
• Completion: 2009-07-01
• First posted: 2008-10-31
• Last updated: 2026-01-02
• Results posted: 2026-01-02

Locations

30 sites across 1 country: United States