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

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Seqirus

Status and phase

Active, not recruiting
Phase 3

Conditions

Influenza, Human

Treatments

Biological: aQIV
Biological: QIV

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 aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a non-adjuvanted quadrivalent influenza vaccine (QIV) in adults ≥65 years of age. The aim of the study is to evaluate aQIV compared with QIV 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.

  • 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

In order to participate in this study, all subjects must not meet any of the exclusion criteria described below:

  • 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;
  • 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;
  • Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
  • Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
  • 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.
  • Acute (severe) febrile illness.
  • 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.
  • Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.
  • Participation in the current study for more than one season.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

35,800 participants in 2 patient groups

aQIV
Experimental group
Description:
MF59-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
Treatment:
Biological: aQIV
Comparator QIV
Other group
Description:
Non-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
Treatment:
Biological: QIV

Trial contacts and locations

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Central trial contact

Clinical Trial Disclosure Manager; Use Central Contact

Data sourced from clinicaltrials.gov

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