A vaccine to protect against infection with the bird flu virus, the pathogen experts fear is capable of causing pandemic disease in humans, proved safe and effective in a preliminary clinical trial with children, mirroring the results of a recent trial conducted in adults, Hungarian researchers report in the Pediatric Infectious Disease Journal.

Fluval (also called avian influenza A (H5N1) vaccine) was developed and produced by Omninvest LTD (Hungary), report Dr. Zoltan Vajo, of the National Center for Immunology and Allergy in Budapest, and co-authors.

Twelve healthy children, 9 to 17 years of age, received a single dose of Fluval by intramuscular injection. No side effects were detected.

On day 21, the rate of protection was 75 percent. Similar results using the same vaccine were reported last year following a clinical trial involving 146 adults.

This vaccine fulfilled all U.S. and European criteria required for licensure, the authors note.

Vajo’s team also points out that Fluval requires only one dose, while other H5N1 vaccines approved by regulatory agencies require more doses, with at least two injections administered 21 to 28 days apart.

SOURCE: Pediatric Infectious Disease Journal, December 2008.