A Phase I/IIa Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of an H5N1 Virus-Like Particle (VLP) Influenza Vaccine (Recombinant)

NCT00519389 Phase 1/Phase 2 COMPLETED

This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or placebo in healthy adults 18 to 40 years of age.

Details

Lead sponsor	Novavax
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	230
Start date	2007-07
Completion	2008-11

Conditions

• Pandemic Influenza

Interventions

• H5N1 VLP Vaccine
• Placebo

Primary outcomes

• Safety and reactogenicity of H5N1 VLP Vaccine — 6 months

Countries

United States