Novavax Inc. (NVAX), on Tuesday announced positive top-line-data from its Phase II dose-ranging clinical trial of its vaccine for respiratory syncytial virus in women of childbearing age. The company in a statement added that the progress supported progression to the next stage of advanced clinical testing.
The Phase II clinical study comprising 330 women of child-bearing age, examined the safety and immunogenicity of two-dose levels of Novavax' RSV F protein nanoparticle vaccine candidate with and without aluminum phosphate as an adjuvant.
The company said that the participants reported mild to moderate headache, fatigue and muscle ache, and added that it shall continue to evaluate safety over a total period of six months and immunogenicity for four months respectively.
Through the trial, the company believes that the antibodies in such vaccinated women could be expected to be naturally transferred to their infants in utero and thereby conferring passive protection at the earliest stage of life, as infants are extremely vulnerable to severe respiratory disease due to RSV.
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