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A Phase 3, Randomized, Observer-blind, Active-controlled Study to Investigate the Safety, Reactogenicity, and Efficacy of mRNA-1010 Candidate Seasonal Influenza Vaccine Compared with a Licensed Inactivated Seasonal Influenza Vaccine in Adults ≥50 Years of Age
A Phase 3, Randomized, Observer-blind, Active-controlled Study to Investigate the Safety, Reactogenicity, and Efficacy of mRNA-1010 Candidate Seasonal Influenza Vaccine Compared with a Licensed Inactivated Seasonal Influenza Vaccine in Adults ≥50 Years of Age
Updated 14 October 2024
Participants will be randomized in a 1:1 ratio to receive a single dose of mRNA-1010 or an active comparator. Randomization will be stratified by age category (≥ 50 to < 65 years or ≥ 65 years), influenza vaccine status in the previous influenza season (received or not received), and prior receipt of any mRNA investigational influenza vaccine (received or not received) at Screening. Approximately 50% of enrolled participants will be ≥ 65 years of age, including approximately 10% who are ≥ 75 years of age at Screening.
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