Johnson & Johnson said on Thursday it has fully enrolled participants for the first late-stage trial of its Covid-19 single-dose vaccine candidate.
The study, named Ensemble, has enrolled about 45,000 participants and is being conducted by its unit Janssen, J&J said in a statement, adding that it expects interim data from the trial by the end of January 2021.
J&J also said it plans to submit an emergency use authorization application to the US Food and Drug Administration in February if the data from the study is safe and effective.
A separate late-stage clinical trial of an investigational Covid-19 vaccine candidate by Janssen to explore a two-dose regimen was ongoing, J&J said.
The Ensemble trial was paused for over a week in October after a patient developed an “unexplained illness” during the study. The company later said it would resume the trial after an evaluation found no clear cause for the illness.