A phase 3 randomized, observer-blind, controlled study to evaluate the immunogenicity, reactogenicity and safety of an mRNA-based seasonal influenza vaccine, in adults 18-64 years of age

Condition studied

Influenza, Human

Investigational medicinal product(s)

Eligibility

Primary endpoint

•HI titers at Day 29 •NI titers at Day 29 •HI seroconversion from baseline to Day 29, Solicited AEs • Occurrence of any solicited administration site and systemic events during the 7 days following study intervention administration. Unsolicited AEs • Occurrence of unsolicited AEs during the 28 days following study intervention administration. MAAEs, SAEs and AESIs • Occurrence of SAEs and AESIs up to 6 months following study intervention administration.

Endpoint detail

• HI titers at Day 29 • HI seroconversion from baseline to Day 29, • Fold increase in HI titers at Day 29 relative to baseline • HI seroprotection at baseline and Day 29 • NI titers at Day 29 • Fold increase in NI titers at Day 29 relative to baseline • NI seroconversion from baseline to Day 29 • Virus neutralization titers at Day 29 by MN assay • Fold increase in virus neutralization titers at Day 29 relative to baseline • Virus neutralization seroconversion from baseline to Day 29