December 2, 2009 / 2:34 PM / 10 years ago

UPDATE 1-Novavax says H1N1 flu vaccine shows positive results

* Says independent panel finds vaccine well-tolerated

* Says panel recommends second part of trial to proceed

* Shares up 8 pct in pre-market trade

Dec 2 (Reuters) - Vaccine maker Novavax (NVAX.O) said its H1N1 flu vaccine showed positive results in the first phase of a two-part, mid-stage study, sending its shares up 8 percent.

The company said the first phase had enrolled 1,000 healthy volunteers aged between 18 and 64 years to receive two doses of 5 micrograms (mcg), 15 mcg or 45 mcg of its vaccine or dummy drug to determine the safety and immunogenicity of the vaccine.

A review of the preliminary data by an independent panel 14 days after the first dose showed that the vaccine was well tolerated at all three dose levels and exhibited no systemic side effects.

The company, which is conducting the study in partnership with Mexico’s Avimex Laboratories, said the panel has recommended that the trial proceed into the second phase, testing on 3,000 subjects with a 15 mcg single-dose regimen.

Shares of the Rockville, Maryland-based company rose 8 percent to $3.48 in pre-market trade. They closed at $3.21 Tuesday on Nasdaq. (Reporting by Anuradha Ramanathan in Bangalore; Editing by Deepak Kannan) ((anuradha.ramanathan@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800: Reuters Messaging: anuradha.ramanathan.reuters.com@reuters.net))

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