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Phase 3 study ENSEMBLE is a randomized, double-blind, placebo-controlled clinical trial designed to assess the safety and effective of single-dose vaccines and placebos in up to 60,000 adults 18 years of age and older, including a significantly representative population over 60 years of age.
subjects of the study will include people with increased risk of severe neocyctic pneumonia, as well as those without the condition, and participants will be recruited in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States.
to assess the effectiveness of Jansen's vaccine against neo-crown pneumonia, trials will be conducted in countries and clinical trial sites with high rates of neo-crown pneumonia and rapid start-up.
Under the Other Transaction Agreement (OTA) (HHSO1001700018C), Phase 3 clinical trial ENSEMBLE is co-sponsored by the U.S. Biomedical Advanced Research and Development Administration (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID), of which BARDA is part of the Office of the Assistant Secretary of Disaster Preparedness and Response of the U.S. Department of Health and Human Services (HHS) and NIAID is part of the National Institutes of Health (NIH).
same time, Johnson and Johnson has agreed in principle to work with the UK government to conduct independent Phase 3 clinical trials in several countries to explore more possibilities for a two-dose option for Janssen's vaccine candidate.
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