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Phase 3 trial of Novavax investigational Coronavirus vaccine starts
Phase 3 trial of Novavax investigational Coronavirus vaccine starts
The Phase 3 trial of another investigational Covid-19 vaccine developed by biotechnology company Novavax, Inc., has started enrolling adult volunteers, the US National Institutes of Health (NIH) announced.
Washington:The Phase 3 trial of another investigational Covid-19 vaccine developed by biotechnology company Novavax, Inc., has started enrolling adult volunteers, the US National Institutes of Health (NIH) announced.
In a statement issued on Monday, the NIH said that the randomised, placebo-controlled trial will enrol approximately 30,000 people at some 115 sites in the US and Mexico, reports Xinhua news agency.
It will evaluate the safety and efficacy of NVX-CoV2373, the vaccine candidate.
Volunteers will be asked to give informed consent prior to their participation in the trial, according to the NIH statement.
They will be grouped into two cohorts: individuals 18 through 64 years old and those aged 65 and older, with a goal of enrolling at least 25 percent of all volunteers who are 65 years old or older, it said.
Participants will be followed closely for potential vaccine side effects and will be asked to provide blood samples at specified time points after each injection and during the following two years, according to the NIH.
Scientists will analyse the blood samples to detect and quantify immune responses to SARS-CoV-2, the virus that causes Covid-19.
Novavax is leading the trial as the regulatory sponsor.
The US National Institute of Allergy and Infectious Diseases, and the Biomedical Advanced Research and Development Authority, are funding the trial.
