At a glance
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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)
In Brief
A Phase 3 clinical trial evaluating Inactivated seasonal influenza vaccine (split virus, Vero cell-derived) and Phosphate buffered saline for Influenza. Completed, enrolled 3,670 participants across 34 sites.
Detailed 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.
Study Details
Timeline
Interventions
Trivalent, non-adjuvanted vaccine; dose: 0.5 ml
Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml