Moderna’s mRNA influenza vaccine, mRNA-1010, met all coprimary endpoints across all 4 A and B strains (A/H1N1, A/H3N2, influenza B/Yamagata, B/Victoria) compared with a licensed comparator, according to results from a phase 3 study.
The phase 3 P303 study (ClinicalTrials.gov Identifier: NCT05827978) evaluated the immunogenicity, reactogenicity, and safety of mRNA-1010 seasonal influenza vaccine in adults 18 years of age and older. Study participants were randomly assigned to receive a single intramuscular dose of mRNA-1010 or Fluarix, a licensed quadrivalent inactivated seasonal influenza vaccine.
Interim analysis showed that the mRNA-1010 vaccine met all coprimary endpoints demonstrating higher hemagglutination inhibition (HAI) geometric mean titers and seroconversion rates for all 4 strains compared with Fluarix.
Findings from a phase 1/2 head-to-head study also showed that mRNA-1010 elicited higher HAI titers against A/H1N1, A/H3N2, and B/Victoria and comparable titers to B/Yamagata when compared with Fluzone High-Dose, a quadrivalent influenza vaccine indicated for individuals 65 years of age and older.
“Our mRNA platform is working,” said Stéphane Bancel, CEO of Moderna. “With today’s positive phase 3 flu results, along with previous results in COVID and RSV, we are now three for three on advancing respiratory disease programs to positive phase 3 data.”
Moderna expands the field of mRNA medicine with positive clinical results across cancer, rare disease, and infectious disease. News release. Moderna. September 13, 2023. https://investors.modernatx.com/news/news-details/2023/Moderna-Expands-the-Field-of-mRNA-Medicine-with-Positive-Clinical-Results-Across-Cancer-Rare-Disease-and-Infectious-Disease/default.aspx.