Dec 17 (Reuters) – Johnson & Johnson said on Thursday that it has fully enrolled participants in the first late phase of the study of its single-dose COVID-19 vaccine.
The study, called Ensemble, has enrolled approximately 45,000 participants and is being conducted by the Janssen unit, J&J said in a statement here, adding that it expects interim data from the study by the end of January 2021.
J&J also said it plans to file an emergency use permit with the U.S. Food and Drug Administration (FDA) in February if the data from the study is safe and effective.
A separate late-stage clinical trial of a COVID-19 vaccine candidate by Janssen to investigate a two-dose regimen was underway, J&J said.
The Ensemble study was interrupted for more than 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 disease.
Reporting by Derek Francis in Bengaluru; edited by Uttaresh.V