Vaccine and Treatment Evaluation Units (VTEU)

Document text

Principal Investigator: HANA M EL SAHLY
Organization: BAYLOR COLLEGE OF MEDICINE
Fiscal Year: 2020
Award: $5,921,655
Funding agency: National Institute of Allergy and Infectious Diseases

ABSTRACT
This supplement request is for a Phase 3, randomized, stratified, observer-blind, placebo-
controlled study to evaluate the efficacy, safety and immunogenicity, of mRNA-1273 vaccine
compared to placebo in adults 18 years of age and older who have no known history of SARS-
CoV-2 infection but whose locations or circumstances put them at appreciable risk of acquiring
COVID-19 and/or SARS-CoV-2 infection. This request also relates to other COVID 19 activities.

Terms: <18 year old><18 years of age><2019 novel coronavirus><2019-nCoV><21+ years old><Adult><Adult Human><COVID-19><COVID19><Evaluation><History><Infection><Location><Messenger RNA><Phase><Placebos><Randomized><Recording of previous events><Risk><SARS-CoV-2><SARS-CoV2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related coronavirus 2><Safety><Severe acute respiratory syndrome coronavirus 2><Sham Treatment><Vaccine Clinical Trial><Vaccines><Wuhan coronavirus><adulthood><age 18 years><blind><corona virus disease 2019><coronavirus disease 2019><eighteen year old><eighteen years of age><immunogenicity><mRNA><placebo controlled study><randomisation><randomization><randomly assigned><sham therapy>