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Novavax RSV Vaccine Mid-Stage Trial Shows Positive Results

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4/2/2013 6:20 PM ET

Shares of Novavax Inc.(NVAX: Quote) rose over five percent in after-hours trade Tuesday after its mid-stage study of a vaccine for the treatment of respiratory diseases in women of childbearing age met trial goals.

Top-line data from the phase II trial of respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age accomplished the trial's protocol-specified objectives and supports progression to the next stage of advanced clinical testing, the company said in a statement.

Novavax said the the antibodies in vaccinated women can be expected to be naturally transferred to their infants in utero and thereby may confer passive protection at the earliest stage of life when these infants are extremely vulnerable to severe respiratory disease due to the virus.

The mid-stage study enrolled 330 women of childbearing age who received either one or two injections of a single-dose of vaccine or placebo. The trial evaluated the safety and immunogenicity of two doses of vaccine with and without aluminum phosphate as an adjuvant.

Novavax said the vaccine was well-tolerated and the safety profile was similar to that observed in the early-stage clinical trial.

"These results confirm that our RSV vaccine candidate has the potential to induce clinically useful immunity and has raised no safety concerns. The primary immunogenicity measures confirmed that the vaccine is a potent antigen and the aluminum phosphate adjuvant further enhanced the antibody responses," said Gregory Glenn SVP and Chief Medical Officer of Novavax.

NVAX closed Tuesday's trading at $2.35, down $0.02 or 0.84%, on a volume of 1.8 million shares on the Nasdaq. The stock gained $0.13 or 5.53% in after-hours trade.

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by RTT Staff Writer

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