Safety and Immunogenicity of an MF59-Adjuvanted Influenza Vaccine in Older Adults

A Phase 2, Randomized, Stratified, Observer-Blind Clinical Study to Evaluate Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine in Older Adults

This Phase 2, randomized, observer-blind, active controlled clinical study is evaluating the safety and immunogenicity of the investigational MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 480 subjects are to be randomized into 1 of 4 possible treatment groups (investigational Influenza Vaccine or licensed Quadrivalent Influenza Vaccine comparators) at 120 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 serum.

Study Overview

• Status: Completed
• Conditions: Influenza; Human
• Intervention / Treatment: Biological: Investigational aIIV4c; Biological: aIIV4; Biological: IIV4c; Biological: RIV4

• Study Type: Interventional
• Enrollment (Actual): 471
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • 4022 - Coastal Clinical Research, an AMR company
  • Arizona
    • Tempe, Arizona, United States, 85283
      • 4002 - Clinical Research Consortium, an AMR company
  • Florida
    • Jacksonville, Florida, United States, 32205
      • 4006 - Westside Center for Clinical Research
    • Jacksonville, Florida, United States, 32216
      • 4013 - Jacksonville Center for Clinical Research
    • Oakland, Florida, United States, 33334
      • 4021 - Research Centers of America, LLC
  • Idaho
    • Boise, Idaho, United States, 83642
      • 4023 - Advanced Clinical Research
  • Kansas
    • Newton, Kansas, United States, 67114
      • 4010 - Heartland Research Associates, LLC
    • Wichita, Kansas, United States, 67207
      • 4016 - Heartland Research Associates, LLC - An AMR Company
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • 4001 - Central Kentucky Research Associates, an AMR company
  • Louisiana
    • Kenner, Louisiana, United States, 70065
      • 4014 - Medpharmi
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • 4008 - The Center for Pharmaceutical Research, an AMR company
    • Saint Louis, Missouri, United States, 63141
      • 4024 - Sundance Clinical Research, LLC
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • 4009 - Meridian Clinical Research, LLC
  • New York
    • Binghamton, New York, United States, 13901
      • 4007 - Regional Clinical Research / United Medical Associates
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • 4012 - M3 Wake Research, Inc.
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • 4004 - Sterling research
    • Cleveland, Ohio, United States, 44122
      • 4017 - Rapid Medical Research, Inc.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • 4011 - Lynn Health Science Institute
  • Texas
    • San Antonio, Texas, United States, 78229
      • 4005 - Clinical Trials of Texas, Inc.
    • Tomball, Texas, United States, 77375
      • 4018 - Martin Diagnostic Clinic
  • Utah
    • West Jordan, Utah, United States, 84088
      • 4020 - Advanced Clinical Research

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Individuals 50 years of age and older 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.

Exclusion Criteria:

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 until 2 months after the study vaccination.
2. Progressive, unstable or uncontrolled clinical conditions.
3. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
4. History of any medical condition considered an adverse event of special interest.
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. Received immunoglobulins or any blood products within 180 days prior to informed consent.
9. Received an investigational or non-registered medicinal product within 30 days prior to vaccination.
10. Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
11. Study personnel or immediate family or household member of study personnel.
12. Receipt of any influenza vaccine within 6 months prior to vaccination in this study, or plan to receive an influenza vaccine during the study period.
13. Acute (severe) febrile illness
14. 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 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: Investigational aIIV4c group; aIIV4c will be administered as a single dose intramuscularly on Day 1	Biological: Investigational aIIV4c; Investigational MF59 Adjuvanted Cell-derived 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 IIV4c group; IIV4c will be administered as a single dose intramuscularly on Day 1	Biological: IIV4c; Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Active Comparator: licensed aIIV4 group; aIIV4 will be administered as a single dose intramuscularly on Day 1	Biological: aIIV4; Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Active Comparator: licensed RIV4 group; RIV4 will be administered as a single dose intramuscularly on Day 1	Biological: RIV4; Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses		28 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses		28 days post-vaccination
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses	Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers	28 days post-vaccination
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses		28 days post-vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions	The percentage of subjects with at least one solicited AE Day 1 through Day 7 after study vaccination.	7 days post-vaccination
Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events	The percentage of subjects with at least one unsolicited AE from Day 1 to Day 29. Related AEs = considered at least possibly related to study vaccination by the investigator.	28 days post-vaccination
Safety Endpoint: 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) During the Entire Study Period		180 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses		28 days post-vaccination
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay Using Cell-derived Target Viruses		28 days post-vaccination
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses	Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers	28 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses		180 days post-vaccination
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses		180 days post-vaccination
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses		180 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses		180 days post-vaccination
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses		180 days post-vaccination

Collaborators and Investigators

• Sponsor: Seqirus
• Investigators: Study Director: Clinical Program Director, Seqirus

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2020
• Primary Completion (Actual): March 19, 2021
• Study Completion (Actual): May 24, 2021

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: October 2, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Influenza; Vaccine; Adjuvant; MF59
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: V200_10

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 Common Technical Documents (CTD) modules submitted to regulatory agencies for public release.

Summary results disclosure is either in document form (e.g., International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (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 last patient last visit (LPLV) 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