Study to Evaluate Immunogenicity, Safety and Tolerability of Adjuvanted and Non-Adjuvanted H2N3 Influenza Vaccines in Adults

About the trial

Sponsor

Seqirus (with Biomedical Advanced Research and Development Authority)

Tested

Low dose A/H2N3c + standard dose MF59 (biological), Intermediate dose A/H2N3c + standard dose MF59 (biological), High dose A/H2N3c + standard dose MF59 (biological), High dose A/H2N3c non-adjuvanted (biological), Lowest dose A/H2N3c + high dose MF59 (biological), Low dose A/H2N3c + high dose MF59 (biological)

Dates

Started 2023-06-15; completion 2024-11-15

Results posted

Not yet

This Phase 1, randomized, observer-blind, dose-ranging clinical study is evaluating 6 different formulations of MF59-adjuvanted and non-adjuvanted H2N3 influenza vaccine. Approximately 600 healthy adult subjects are to be randomized into 1 of 6 possible treatment groups with 100 subjects per group, stratified by age group (born after or before 1968). Each subject will receive an influenza vaccine injection on Day 1 and Day 22. Subjects will be followed up for approximately 12 months after the second vaccine injection. The primary immunogenicity analysis is based on the Day 1, Day 8, Day 22, Day 29, and Day 43 serology data. The primary safety analysis is based on solicited local and syste…

From ClinicalTrials.gov, last updated 2026-09-21. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Seqirus USA Inc reported $248,095 in research payments for this study in 2025 (16 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.