Leiden, Netherlands-based biotechnology company Crucell NV has commenced a large randomized, observer-blind and dose-ranging study to test its vaccine against avian influenza virus in humans. The trial, performed in collaboration with a team based in Leicester, UK, will oversee the vaccination of 560 healthy adults.
Crucell stated that three types of vaccine will be tested for safety and immunogenicity: its non-adjuvanted whole virion vaccine, an alum-adjuvanted whole virion vaccine and a virosomal subunit vaccine, all based on the H9N2 virus. The whole virion vaccine will be administered by both intramuscular and intradermal routes.
The firm noted that trials with potentially-pandemic subtypes of influenza A such as H9N2 can be used in support of a pandemic core dossier, and could form the basis for rapid approval by regulatory authorities worldwide of a vaccine against an actual pandemic threat once it emerges.
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