A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age

Overview

This Phase 3 study is a randomized, observer-blind study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a licensed quadrivalent influenza vaccine in adults 50 to 64 years of age. The aim of the study is to demonstrate a noninferior immune response for aQIV versus the comparator vaccine for all four vaccine strains, and a superior immune response for at least two of the four vaccine strains.

Full Title of Study: “A Phase 3, Randomized, Observer-blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of an MF59-adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine in Comparison With a Licensed Quadrivalent Influenza Vaccine, in Adults 50 to 64 Years of Age”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 9, 2023

Interventions

  • Biological: aQIV
    • Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
  • Biological: Comparator QIV
    • Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1

Arms, Groups and Cohorts

  • Experimental: aQIV
    • Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
  • Active Comparator: Comparator QIV
    • Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains

Clinical Trial Outcome Measures

Primary Measures

  • Immunogenicity Endpoint: Geometric mean titer (GMT) and GMT ratio of hemagglutination inhibition (HI) antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
    • Time Frame: Day 22
  • Immunogenicity Endpoint: Seroconversion rate (SCR) and SCR difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
    • Time Frame: Day 1 to Day 22

Secondary Measures

  • Immunogenicity Endpoint: GMT and GMT ratio of HI antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
    • Time Frame: Day 22
  • Immunogenicity Endpoint: GMT and GMT ratio of HI antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
    • Time Frame: Day 181
  • Immunogenicity Endpoint: GMT and GMT ratio of HI antibodies at Day 271 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
    • Time Frame: Day 271
  • Immunogenicity Endpoint: GMT of HI antibodies on Day 1, Day 22, Day 181, and Day 271 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
    • Time Frame: Day 1 to Day 271
  • Immunogenicity Endpoint: Geometric mean fold increase (GMFI) for Day 22/Day 1, Day 181/Day 1, and Day 271/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
    • Time Frame: Day 1 to Day 271
  • Immunogenicity Endpoint: The percentage of subjects with a titer ≥1:40 at Day 1, Day 22, Day 181, and Day 271 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
    • Time Frame: Day 1 to Day 271
  • Immunogenicity Endpoint: SCR at Day 22, Day 181, and Day 271 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
    • Time Frame: Day 1 to Day 271
  • Safety Endpoint: Solicited local and systemic AEs for 7 days following vaccination
    • Time Frame: Day 1 through Day 7
  • Safety Endpoint: All unsolicited AEs for 21 days following vaccination
    • Time Frame: Day 1 through Day 22
  • Safety Endpoint: Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal from the study, and Adverse Events of Special Interest (AESIs)
    • Time Frame: Day 1 through Day 271

Participating in This Clinical Trial

Inclusion Criteria

In order to participate in this study, all subjects must meet ALL of the following inclusion criteria:

  • Individuals 50 through 64 years of age on the day of informed consent – Individuals who have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry – Individuals who can comply with study procedures including follow-up – Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method, at least 30 days prior to informed consent, which they intend to use for at least 2 months after the study vaccination Exclusion Criteria:

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

  • Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to study entry and who do not plan to do so until 2 months after the study vaccination – Progressive, unstable or uncontrolled clinical conditions – Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study – History of any medical condition considered an AESI – Known history of Guillain Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis – Clinical conditions representing a contraindication to intramuscular vaccination and blood draws – 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 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 is also permitted 3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent – Received immunoglobulins or any blood products within 180 days prior to informed consent – Received an investigational or non-registered medicinal product within 30 days prior to informed consent, or who are unwilling to refuse participation in another clinical study at any time during the conduct of this study (note: concomitant participation in an observational study not involving drugs, vaccines, or medical devices, is acceptable) – Receipt of any influenza vaccine within 6 months prior to enrollment in this study, or plan to receive influenza vaccine during the study period – Receipt of any (investigational or licensed) COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to enrollment or plan to receive any COVID-19 vaccine within 7 days from study vaccination – Receipt of any inactivated non-influenza vaccine within 14 days or live-attenuated vaccine within 28 days prior to enrollment in this study or plan to receive any other non-influenza vaccine within 28 days from study vaccination – 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 or household member of study personnel

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Seqirus
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Program Director, Study Director, Seqirus
  • Overall Contact(s)
    • Clinical Trial Disclosure Manager, +1 855 358 8966, seqirus.clinicaltrials@seqirus.com

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