At a glance
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Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern
In Brief
A Phase 3 clinical trial evaluating Moderna mRNA-1273, Moderna mRNA-1273.222, and 2 other interventions for SARS-CoV-2 Infection and 2 related conditions. Completed, enrolled 14,237 participants across 47 sites in 7 countries.
Detailed Summary
The study will evaluate the clinical efficacy of different dosing regimens of the Moderna COVID-19 mRNA vaccine (100 mcg) in preventing COVID-19 disease in people who are living with HIV or have comorbidities associated with elevated risk of severe COVID-19, with the different vaccine regimens assessed determined by whether the participant had evidence of prior SARS-CoV-2 infection at enrollment.
Study Details
Timeline
Interventions
COVID-19 vaccine (mRNA-1273) developed by Moderna, Inc. is a lipid nanoparticle (LNP) dispersion of a messenger ribonucleic acid (mRNA) encoding the prefusion stabilized S protein of SARS-CoV-2 formulated in LNPs composed of 4 lipids (1 proprietary and 3 commercially available).
COVID-19 vaccine (mRNA-1273.222) developed by Moderna, Inc. is an updated bivalent version of Moderna's mRNA-1273 vaccine, composed of equal parts of mRNA-1273 and mRNA that encodes the S protein of the Omicron subvariants BA.4/.5 (which have the same S protein).
COVID-19 mRNA vaccine in 100 mcg dose given as IM injection into the deltoid muscle on Months 0, 1, and 6.
COVID-19 mRNA vaccine is to be administered as IM injection into the deltoid muscle on Months 0 and 6.