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
1 other identifier
interventional
471
1 country
21
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2020
Shorter than P25 for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2020
CompletedFirst Posted
Study publicly available on registry
October 6, 2020
CompletedStudy Start
First participant enrolled
October 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2021
CompletedResults Posted
Study results publicly available
April 17, 2024
CompletedApril 17, 2024
April 1, 2024
5 months
September 17, 2020
March 5, 2024
April 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (11)
Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions
7 days post-vaccination
Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events
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
- +6 more secondary outcomes
Study Arms (4)
Investigational aIIV4c group
EXPERIMENTALaIIV4c will be administered as a single dose intramuscularly on Day 1
licensed IIV4c group
ACTIVE COMPARATORIIV4c will be administered as a single dose intramuscularly on Day 1
licensed aIIV4 group
ACTIVE COMPARATORaIIV4 will be administered as a single dose intramuscularly on Day 1
licensed RIV4 group
ACTIVE COMPARATORRIV4 will be administered as a single dose intramuscularly on Day 1
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Individuals 50 years of age and older 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.
You may not qualify if:
- 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.
- 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 adverse event of special interest.
- Known history of Guillain Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
- Clinical conditions representing a contraindication 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 of ≥ 20 mg/day of prednisone or equivalent for more than 14 consecutive days within 90 days prior to informed consent5.
- 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 vaccination.
- 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.
- Study personnel or immediate family or household member of study personnel.
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seqiruslead
Study Sites (21)
4022 - Coastal Clinical Research, an AMR company
Mobile, Alabama, 36608, United States
4002 - Clinical Research Consortium, an AMR company
Tempe, Arizona, 85283, United States
4006 - Westside Center for Clinical Research
Jacksonville, Florida, 32205, United States
4013 - Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
4021 - Research Centers of America, LLC
Oakland, Florida, 33334, United States
4023 - Advanced Clinical Research
Boise, Idaho, 83642, United States
4010 - Heartland Research Associates, LLC
Newton, Kansas, 67114, United States
4016 - Heartland Research Associates, LLC - An AMR Company
Wichita, Kansas, 67207, United States
4001 - Central Kentucky Research Associates, an AMR company
Lexington, Kentucky, 40509, United States
4014 - Medpharmi
Kenner, Louisiana, 70065, United States
4008 - The Center for Pharmaceutical Research, an AMR company
Kansas City, Missouri, 64114, United States
4024 - Sundance Clinical Research, LLC
St Louis, Missouri, 63141, United States
4009 - Meridian Clinical Research, LLC
Omaha, Nebraska, 68134, United States
4007 - Regional Clinical Research / United Medical Associates
Binghamton, New York, 13901, United States
4012 - M3 Wake Research, Inc.
Raleigh, North Carolina, 27612, United States
4004 - Sterling research
Cincinnati, Ohio, 45219, United States
4017 - Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
4011 - Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
4005 - Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
4018 - Martin Diagnostic Clinic
Tomball, Texas, 77375, United States
4020 - Advanced Clinical Research
West Jordan, Utah, 84088, United States
Related Publications (1)
Essink BJ, Vermeulen W, Andrade C, de Rooij R, Isakov L, Casula D, Albano FR. A randomised phase 2 immunogenicity and safety study of a MF59-adjuvanted quadrivalent subunit inactivated cell-derived influenza vaccine (aQIVc) in adults aged 50 years and older. Vaccine. 2025 Apr 2;51:126791. doi: 10.1016/j.vaccine.2025.126791. Epub 2025 Feb 12.
PMID: 39946829DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Seqirus Clinical Trial Manager
- Organization
- Seqirus
Study Officials
- STUDY DIRECTOR
Clinical Program Director
Seqirus
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2020
First Posted
October 6, 2020
Study Start
October 8, 2020
Primary Completion
March 19, 2021
Study Completion
May 24, 2021
Last Updated
April 17, 2024
Results First Posted
April 17, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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
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 \[EU CTR\])