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news.Biotechnology firm Novavax has completed enrollment in the Phase I/IIa study of the company's pandemic influenza vaccine including a total of approximately 230 subjects.
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The interim findings from first Phase of the study suggested that the vaccine is well tolerated and immunogenic at the 15 microgram and 45 microgram dose levels. Based upon its review of these results, the data and safety monitoring board recommended that the study continue.
Enrollment has now been completed in the second phase of the trial, which includes approximately 160 healthy adult volunteers. The safety and immunogenicity of three vaccine doses (15 micrograms, 45 micrograms and 90 micrograms) as compared with placebo will be evaluated. Top-line results for this trial are expected in the third quarter 2008.
Rahul Singhvi, president and CEO of Novavax, said: “This is an important study because the safety data collected in this trial will also be used to support the safety database for our seasonal influenza vaccine program, which is expected to begin with a Phase IIa study in the third quarter of 2008.”