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Novavax initiates second early-stage trial of bird flu vaccine candidate

Thursday, May 10 2012 | Comments
Evidence Grade 0 What's This?
Novavax Inc. started a second Phase I study of its monovalent virus-like particle (VLP) vaccine candidate to prevent potential pandemic disease stemming from A/H5N1 avian influenza viruses. 

The purpose of the randomized, observer-blinded, dose-ranging trial is to evaluate the safety of the VLP A/H5N1 avian flu vaccine candidate and determine its immunogenicity with and without the use of an adjuvant. The design of the trial is identical to that of another A/H5N1 VLP vaccine study Novavax initiated earlier this month.

The target enrollment of the current study is 333 healthy participants, who will be randomized into six treatment groups that will include varying doses of the vaccine, with or without an adjuvant, or placebo. The study participants will receive two identical intramuscular injections at a 21-day interval, with follow-up approximately 13 months from the first dose. 

Novavax is developing the vaccine under a contract with Department of Health and Human Services' Biomedical Advanced Research and Development Authority.

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