A phase 3 randomized, observer-blind, controlled study to evaluate the clinical efficacy of an mRNA- based seasonal influenza vaccine in older adults ≥65 years of age

Condition studied

Influenza, Human

Investigational medicinal product(s)

Eligibility

Primary endpoint

First occurrence, at least 14 days after dosing, of laboratory-confirmed cases of protocol-defined ILI caused by influenza A subtypes H1N1 or H3N2 or influenza B/Victoria, Occurrence of any solicited administration site and systemic events during the 7 days (including the day of study intervention administration) following study intervention administration (Day 1 to Day 7), Occurrence of unsolicited AEs during the 28 days (including the day of study intervention administration) following study intervention administration (Day 1 to Day 28), Occurrence of SAEs and AESIs up to the end of the corresponding influenza season (with at least 180 days of follow-up), For additional primary end points, kindly refer to the protocol (Section 3)

Endpoint detail

First occurrence, at least 14 days after dosing, of laboratory-confirmed cases of protocol-defined ILI, caused by influenza A subtypes H1N1 or H3N2 or influenza B/Victoria, First occurrence, at least 14 days after dosing, of laboratory-confirmed cases of protocol-defined ILI, caused by influenza A subtypes H1N1 or H3N2 or influenza B/Victoria, First occurrence, at least 14 days after dosing, of cases of SID caused by influenza A or B, First occurrence, at least 14 days after dosing, of cases of SID caused by influenza A or B