Active — Not RecruitingPhase 3

A Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Adjuvanted Influenza Vaccine Compared to a Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of Age

United States35,800 participantsStarted 2023-10-23

Plain-language summary

This Phase 3 study is a randomized, observer-blind study of MF59-adjuvanted influenza vaccine (aQIV or aTIV) compared with a non-adjuvanted influenza vaccine (QIV or TIV) in adults ≥65 years of age. The aim of the study is to evaluate MF59-adjuvanted influenza vaccine compared with non-adjuvanted influenza vaccine in the prevention of reverse transcription-polymerase chain reaction (RT-PCR)-confirmed influenza A and/or B in subjects ≥65 years of age.

Who can participate

Age range65 Years

SexALL

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Inclusion criteria

✓. Adults of ≥65 years of age on the day of vaccination.
✓. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
✓. Individuals who have the ability to comply with study procedures including follow-up.

Exclusion criteria

✕. Bedridden subjects (i.e. confined to bed by sickness or old age).
✕. Subjects that are incapacitated and because of that in need of a Legally Authorized Representative.
✕. Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study.
✕. Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study, or severe allergic reaction (e.g. anaphylaxis) to previous influenza vaccination.
✕. Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
✕. Clinical conditions representing a contra-indication to intramuscular administration of vaccines or blood draw.
✕. Abnormal function of the immune system resulting from:
✕. Clinical conditions;

What they're measuring

Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition

Timeframe: From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for Northern Hemisphere [NH] influenza season and end of November for Southern Hemisphere [SH] influenza season)

Trial details

NCT IDNCT06087640

SponsorSeqirus

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11

View on ClinicalTrials.gov More Influenza, Human trials