Phase 3 Randomized, Observer-Blinded, Placebo-Controlled Trial
A Phase 3 Randomized, Observer-Blinded, Placebo-Controlled Trial is a phase 3 trial that is a randomized, observer-blinded, placebo-controlled trial.
- See: Phase 2 Trial.
References
2021
- (Baden et al., 2021) ⇒ Lindsey R. Baden, Hana M. El Sahly, Brandon Essink, Karen Kotloff, Sharon Frey, Rick Novak, David Diemert et al. (2021). “Efficacy and Safety of the MRNA-1273 SARS-CoV-2 Vaccine.” New England Journal of Medicine 384, no. 5
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BACKGROUND: Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle–encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19.
METHODS: This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. ...
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