biostudies-literatureUnknown21(1)Kandinov BModerna, IncThe safety, immunogenicity, and efficacy of the original formulation of the investigational mRNA-1010 vaccine for seasonal influenza were investigated in two randomized, active-controlled, phase 3 trials in adults (NCT05415462 and NCT05566639), and the results were used to evaluate hemagglutination inhibition (HAI) titers as correlates of risk and protection against influenza-like illness. mRNA-1010 (50-µg) demonstrated an acceptable reactogenicity and safety profile among the >14,000 adult participants vaccinated in both trials. The efficacy profile of mRNA-1010 was generally reflective of immunogenicity findings, with higher immune responses against influenza A strains and lower responses against influenza B strains relative to an active comparator (licensed inactivated influenza vaccineHuman vaccines & immunotherapeutics2484088https://www.ebi.ac.uk/biostudies/studies/S-EPMC11970786biostudies-literatureAn mRNA-based seasonal influenza vaccine in adults: Results of two phase 3 randomized clinical trials and correlate of protection analysis of hemagglutination inhibition titers.PMC11970786Hall KFierro CAnanworanich JMiller JSoens MAvanesov AKandinov BNachbagauer RLlapur CRudden SSchaefers KMa CPark YGuo JEssink BHuang WEnsz DDu EZheng LZhou HVakil JPucci AHicks BfalseAn mRNA-based seasonal influenza vaccine in adults: Results of two phase 3 randomized clinical trials and correlate of protection analysis of hemagglutination inhibition titers.The safety, immunogenicity, and efficacy of the original formulation of the investigational mRNA-1010 vaccine for seasonal influenza were investigated in two randomized, active-controlled, phase 3 trials in adults (NCT05415462 and NCT05566639), and the results were used to evaluate hemagglutination inhibition (HAI) titers as correlates of risk and protection against influenza-like illness. mRNA-1010 (50-µg) demonstrated an acceptable reactogenicity and safety profile among the >14,000 adult participants vaccinated in both trials. The efficacy profile of mRNA-1010 was generally reflective of immunogenicity findings, with higher immune responses against influenza A strains and lower responses against influenza B strains relative to an active comparator (licensed inactivated influenza vaccine2025-01-01T00:00:00Z2025 Dec2026-06-02T17:32:43.043Z2025-07-08T03:13:01.512ZS-EPMC119707864017460910.1080/21645515.2025.2484088