Safety and Immunogenicity of an MF59-Adjuvanted Influenza Vaccine in Older Adults
NCT ID: NCT04576702
Last Updated: 2024-04-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
471 participants
INTERVENTIONAL
2020-10-08
2021-05-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Investigational aIIV4c group
aIIV4c will be administered as a single dose intramuscularly on Day 1
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.
licensed IIV4c group
IIV4c will be administered as a single dose intramuscularly on Day 1
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.
licensed aIIV4 group
aIIV4 will be administered as a single dose intramuscularly on Day 1
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.
licensed RIV4 group
RIV4 will be administered as a single dose intramuscularly on Day 1
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
50 Years
ALL
Yes
Sponsors
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Seqirus
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Program Director
Role: STUDY_DIRECTOR
Seqirus
Locations
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4022 - Coastal Clinical Research, an AMR company
Mobile, Alabama, United States
4002 - Clinical Research Consortium, an AMR company
Tempe, Arizona, United States
4006 - Westside Center for Clinical Research
Jacksonville, Florida, United States
4013 - Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
4021 - Research Centers of America, LLC
Oakland, Florida, United States
4023 - Advanced Clinical Research
Boise, Idaho, United States
4010 - Heartland Research Associates, LLC
Newton, Kansas, United States
4016 - Heartland Research Associates, LLC - An AMR Company
Wichita, Kansas, United States
4001 - Central Kentucky Research Associates, an AMR company
Lexington, Kentucky, United States
4014 - Medpharmi
Kenner, Louisiana, United States
4008 - The Center for Pharmaceutical Research, an AMR company
Kansas City, Missouri, United States
4024 - Sundance Clinical Research, LLC
St Louis, Missouri, United States
4009 - Meridian Clinical Research, LLC
Omaha, Nebraska, United States
4007 - Regional Clinical Research / United Medical Associates
Binghamton, New York, United States
4012 - M3 Wake Research, Inc.
Raleigh, North Carolina, United States
4004 - Sterling research
Cincinnati, Ohio, United States
4017 - Rapid Medical Research, Inc.
Cleveland, Ohio, United States
4011 - Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
4005 - Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
4018 - Martin Diagnostic Clinic
Tomball, Texas, United States
4020 - Advanced Clinical Research
West Jordan, Utah, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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V200_10
Identifier Type: -
Identifier Source: org_study_id
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