Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults ≥50 Years of Age

A Phase 2b, Randomized, Observer-Blind, Antigen and Adjuvant Dose-Confirmation Clinical Study to Evaluate Safety and Immunogenicity of Different Formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Cell-derived Influenza Vaccine (aQIVc) in Older Adults ≥50 Years of Age

This Phase 2, randomized, observer-blind, dose-confirmation Clinical study is evaluating different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 1000 subjects are to be randomized into 1 of 4 possible treatment groups with 250 participants per group. Every participant will receive an influenza vaccine injection on Day 1 and will be followed up for approximately 6 months following injection. The primary immunogenicity analysis is based on Day 29 serology data.

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Biological: Experimental: IIV-A Investigational IIV-A will be administered as a single dose intramuscularly on Day 1; Biological: Experimental: aIIV-B Investigational aIIV-B will be administered as a single dose intramuscularly on Day 1; Biological: Experimental: aIIV-C Investigational aIIV-C will be administered as a single dose intramuscularly on Day 1; Biological: Active Comparator: Licensed IIV IIV will be administered as a single dose intramuscularly on Day 1

• Study Type: Interventional
• Enrollment (Actual): 1056
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85281
      • AMR Tempe
  • California
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research
    • San Diego, California, United States, 92123
      • California Research Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80920
      • The Lynn Institute of The Rockies
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Clinical Research Consulting, LLC
  • Florida
    • Clearwater, Florida, United States, 33756
      • Innovative Research of West Florida, Inc.
    • Edgewater, Florida, United States, 32132
      • Velocity Clinical Research - New Smyrna Beach
    • Hollywood, Florida, United States, 33024
      • Cenexel RCA
    • Jupiter, Florida, United States, 33458
      • Health Awareness Inc
    • Miami Lakes, Florida, United States, 33016
      • Global Health Research center
    • Sunrise, Florida, United States, 33351
      • Precision Clinical Research
    • Tampa, Florida, United States, 33615
      • Global Health Research center
  • Georgia
    • Savannah, Georgia, United States, 31405
      • Platinum Research Network, LLC
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research - Savannah
  • Kansas
    • El Dorado, Kansas, United States, 67042
      • AMR El Dorado
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • AMR Lexington
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Meridian Clinical Research
    • Metairie, Louisiana, United States, 70006
      • MedPharmics, LLC
  • Maryland
    • Rockville, Maryland, United States, 20854
      • Rockville Internal Medicine Group
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
      • MedPharmics LLC
  • Missouri
    • Hazelwood, Missouri, United States, 63042
      • Healthcare Research Network
    • Kansas City, Missouri, United States, 64114
      • The Center for Pharmaceutical Research
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical Research, LLC
  • Nebraska
    • Bellevue, Nebraska, United States, 68005
      • Meridian Clinical Research
    • Grand Island, Nebraska, United States, 68803
      • Meridian Clinical Research
    • Lincoln, Nebraska, United States, 68510
      • Meridian Clinical Research, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Alliance for Multispecialty Research, LLC, Las Vegas
  • New York
    • Binghamton, New York, United States, 13901
      • Meridian Clinical Research (Binghamton, NY)
    • Endwell, New York, United States, 13760
      • Meridian Clinical Research, LLC
    • Syracuse, New York, United States, 13057
      • Velocity Clinical Research - Syracuse
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research, Inc.
  • Ohio
    • Cincinnati, Ohio, United States, 45246
      • Meridian Clinical Research, LLC
    • Cincinnati, Ohio, United States, 45219
      • Meridian Clinical Research, LLC
    • Columbus, Ohio, United States, 43213
      • Aventiv Research, Inc. Columbus
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research - Medford
  • South Carolina
    • Gaffney, South Carolina, United States, 29340
      • Velocity Clinical Research, Gaffney
    • Greenville, South Carolina, United States, 29615
      • Velocity Clinical Research - Greenville
    • Spartanburg, South Carolina, United States, 29303
      • Velocity Clinical Research, Spartanburg
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 57049
      • Meridian Clinical Research - Dakota Dunes
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • AMR Coastal Clinical Research
  • Texas
    • Tomball, Texas, United States, 77375
      • DM Clinical Research
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • JBR Clinical Research
    • West Jordan, Utah, United States, 84088
      • Velocity Clinical Research - West Jordan
  • Virginia
    • Charlottesville, Virginia, United States, 22902
      • CVS pharmacy - Charlottesville
    • Reston, Virginia, United States, 20190
      • CVS pharmacy - Reston
    • Richmond, Virginia, United States, 23235
      • CVS pharmacy - Richmond

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

1. Individuals ≥50 years of age on the day of informed consent.
2. 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.
3. Individuals who can comply with study procedures including follow-up .

4. 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.

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Exclusion Criteria:

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

1. 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 informed consent and who do not plan to do so for at least 2 months after the study vaccination.
2. Progressive, unstable or uncontrolled clinical conditions.
3. Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study.
4. History of any medical condition considered an adverse event of special interest (AESI).
5. Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
6. Clinical conditions representing a contraindication 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 of ≥20 mg/day of prednisone or equivalent for more than 14 consecutive days within 90 days prior to informed consent5.
   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 an investigational or non-registered medicinal product within 30 days prior to informed consent.
10. Receipt of any COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to informed consent or plan to receive any COVID-19 vaccine within 7 days from study vaccination
11. Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to informed consent or who are planning to receive any vaccine within 28 days from the study vaccines.
12. Study personnel or immediate family or household member of study personnel.
13. Receipt of any influenza vaccine within 6 months prior to informed consent, or plan to receive an influenza vaccine during the study period.
14. Acute (severe) febrile illness,

15. 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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IIV-A Investigational	Biological: Experimental: IIV-A Investigational IIV-A will be administered as a single dose intramuscularly on Day 1; Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Experimental: aIIV-B Investigational	Biological: Experimental: aIIV-B Investigational aIIV-B will be administered as a single dose intramuscularly on Day 1; Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Experimental: aIIV-C Investigational	Biological: Experimental: aIIV-C Investigational aIIV-C will be administered as a single dose intramuscularly on Day 1; Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Active Comparator: Licensed IIV	Biological: Active Comparator: Licensed IIV IIV will be administered as a single dose intramuscularly on Day 1; Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Immunogenicity Endpoint: Hemagglutination inhibition (HI) titers against vaccine A and B influenza strains	28 days post-vaccination
The Percentage of Subjects with Solicited Local and Systemic Reactions	7 days post-vaccination
The Percentage of Subjects with Unsolicited Adverse Events	28 days post-vaccination
The Percentage of Subjects with Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs)	180 days post-vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Immunogenicity Endpoint: Microneutralization (MN) titers against vaccine A and B influenza strains	28 days post-vaccination

Collaborators and Investigators

• Sponsor: Seqirus

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: influenza, vaccine, MF59, adjuvant
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: V201_07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

SEQIRUS supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the CTD modules submitted to regulatory agencies for public release.

Summary results disclosure is either in document form (e.g., ICH E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry [EU CTR])

• IPD Sharing Time Frame: SEQIRUS discloses results from clinical studies within 12 months of completion of the study unless otherwise mandated by local laws or regulations.
• IPD Sharing Access Criteria: SEQIRUS will consider requests from qualified scientific and medical researchers to disclose protocols, anonymized subject-level data and study-level data when there is medical, scientific and/or public health interest to ensure the safe use of a Seqirus product licensed on or after 1 January 2014 in the United States (US) and/or the European Union (EU). This applies to Seqirus-sponsored interventional studies initiated after 27 September 2007 and ongoing as of 26 December 2007, that have been included as part of a US or EU submission package which received approval in US and EU on or after 1 January 2014 and have been accepted for publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No