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)

NCT00566345 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Alachua Government Services, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	3670
Start date	2007-11
Completion	2008-06

Conditions

• Influenza

Interventions

• Inactivated seasonal influenza vaccine (split virus, Vero cell-derived)
• Phosphate buffered saline

Primary outcomes

• Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens — 21 days to 180 days after the date of vaccination
• The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values — 21 Days after vaccination
  Consistency of each strain across the 3 different lots shown by comparison of the ratios of geometric mean HIA titers at Day 21 between individual lots for the immunogenicity analysis set.

Countries

United States