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

Phase 3Active Not RecruitingNCT06087640

Seqirus35,800 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

35,800

Conditions

Influenza, Human

Interventions

aQIV or aTIVBIOLOGICAL

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: In order to participate in this study, all subjects must meet ALL of the inclusion criteria described. 1. Adults of ≥65 years of age on the day of vaccination. 2. 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. 3. Individuals who have the ability to comply with study procedures including follow-up. Exclusion Criteria: In order to participate in this study, all subjects must not meet any of the exclusion criteria described below: 1. Bedridden subjects (i.e. confined to bed by sickness or old age). 2. Subjects that are incapacitated and because of that in need of a Legally Authorized Representative. 3. Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study. 4. 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. 5. Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis. 6. Clinical conditions representing a contra-indication to intramuscular administration of vaccines or blood draw. 7. Abnormal function of the immune system resulting from: 1. Clinical conditions; 2. Systemic administration of corticosteroids (PO/IV/IM) at a dose ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent; Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted; 3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. 8. Receipt of immunoglobulins or any blood products within 180 days prior to informed consent. 9. Receipt of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the study vaccination, or planned use during the entire study period. 10. Acute (severe) febrile illness. 11. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study. 12. Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.

Outcomes

Primary Outcomes

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

ILI = influenza-like illness; RT-PCR = reverse transcription-polymerase chain reaction

Time frame: 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)

Secondary Outcomes

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