Moderna will launch its pivotal Phase 3 clinical trial of its COVID-19 mRNA-based vaccine called mRNA-1273. The company estimates a start date of July 27, 2020. Some principal investigators notified the TrialSite Network that July 9 was the original start date but delays based on protocol review with NIAID scientists were reported.
Moderna, in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and Biomedical Advanced Research and Development Authority (BARDA), will evaluate the efficacy, safety and immunogenicity of mRNA-1273 to prevent COVID-19 for up to two years after the second dose of the investigational candidate. The study will seek up to 30,000 participants.
The sponsor working collaboratively with NIAID has established four primary outcome measures including 1) number of participants with a first occurrence of COVID-19 starting 14 days after second dose of mRNA (time frame Day 29 (second dose) up to day 759 (2 years after second dose); 2) Number of Participants with Adverse Events (AEs) or Medically Attended AEs (MAAEs) leading to withdrawal (time frame up to day 759); 3) Number of participants with Solicited Local and Systemic Adverse Reactions (ARs) (time frame up to Day 8 (7 days post first dose) and up to Day 36 (7 days after second dose); 4) Number of Participants with Unsolicited AEs (time frame up to Day 57 (28 days after each dose).
Moderna has recruited, in collaboration with NIAID, up to 87 sites in 29 states plus the District of Columbia to date.
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