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December 17 (Reuters) – Johnson & Johnson said on Thursday it had fully recruited participants for the first advanced trial of its single-dose COVID-19 vaccine candidate.
The study, named Ensemble, has recruited around 45,000 participants and is being conducted by its Janssen unit, J&J said in a statement, adding that it expects provisional data from the trial by the end of January 2021.
J&J also said it plans to submit an emergency use clearance application to the U.S. Food and Drug Administration (FDA) in February if the study data is safe and effective.
A separate advanced-stage clinical trial of an experimental COVID-19 vaccine candidate by Janssen to explore a two-dose regimen was underway, J&J said.
The Ensemble trial was suspended for more than a week in October after a patient developed “unexplained illness” during the study. The company later said it would resume the trial after an assessment found no clear cause for the disease.
Reporting by Derek Francis in Bengaluru; edited by Uttaresh.V
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