NCT00566345

Efficacy Study of an Investigational Influenza Vaccine (Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection (CCII)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,670 (actual)
• Sponsor: Alachua Government Services, Inc. · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to demonstrate the efficacy of an investigational Vero-cell derived influenza vaccine to prevent infection in an adult population with an influenza virus that is antigenically similar to one of the three strains in the vaccine. All subjects will be randomized to receive a single 0.5 ml intramuscular injection from one of three lots of seasonal Vero-cell derived influenza vaccine or saline placebo. Subjects will be monitored for 180 days following vaccination for occurrence of adverse events. For determining antibody response, subjects will have one blood draw before and one blood draw 21 days after vaccination.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated seasonal influenza vaccine (split virus, Vero cell-derived)	Trivalent, non-adjuvanted vaccine; dose: 0.5 ml
OTHER	Phosphate buffered saline	Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-12-03
• Last updated: 2023-10-17
• Results posted: 2023-10-17

Locations

34 sites across 1 country: United States