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

Seqirus

Status and phase: Active, not recruiting; Phase 3

Conditions: Influenza, Human

Treatments: Biological: QIV or TIV; Biological: aQIV or aTIV

Study type: Interventional

Funder types: Industry

Identifiers

NCT06087640

V118_24

Details and patient eligibility

About

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.

Enrollment: 35,800 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35,800 participants in 2 patient groups

MF59-adjuvanted influenza vaccine

Experimental group

Description:

MF59-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains or MF59-adjuvanted TIV containing 2 influenza type A strains and 1 influenza type B strain

Treatment:

Biological: aQIV or aTIV

Non-adjuvanted influenza vaccine

Other group

Description:

Non-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains or Non-adjuvanted TIV containing 2 influenza type A strains and 1 influenza type B strain

Treatment:

Biological: QIV or TIV