Study to Assess Safety of an Inactivated H5N1 Influenza Vaccine Administered in GelVac Nasal Powder to Healthy Young Adults

Summary

This is a double-blind, placebo controlled, safety and immunogenicity study of GelVac™ nasal powder H5N1 influenza vaccine. Healthy male and female subjects between 18 and 49 years of age who are eligible for study participation will be enrolled in the trial. It is expected that 10 subjects will be screened to obtain 7 subjects who will be eligible for study participation. The primary objective is to determine the frequency and severity of local and systemic adverse events of vaccine. The secondary objective is to assess the immunogenicity of the vaccine based on geometric mean titers (GMT) of serum HAI, serum neutralizing, and nasal wash IgA antibodies.

Timeline

Start

2010-09

Primary completion

2011-04

Completion

2011-04

Drugs

Indications

No indication recorded.