Clinical trial NCT04576702: Safety and Immunogenicity of an MF59-Adjuvanted Influenza Vaccine in Older Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Human
Keywords: Influenza
Vaccine
MF59
Adjuvant
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2020-10-06
Enrollment: 471
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 28 days post-vaccination
measure: 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
timeFrame: 28 days post-vaccination
measure: 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
timeFrame: 28 days post-vaccination
measure: 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
timeFrame: 28 days post-vaccination
Secondary outcomes:
measure: Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions
timeFrame: 7 days post-vaccination
measure: Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events
timeFrame: 28 days post-vaccination
measure: 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
timeFrame: 180 days post-vaccination
measure: 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
timeFrame: 28 days post-vaccination
measure: 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
timeFrame: 28 days post-vaccination
measure: 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
timeFrame: 28 days post-vaccination
measure: 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
timeFrame: 180 days post-vaccination
measure: 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
timeFrame: 180 days post-vaccination
measure: 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
timeFrame: 180 days post-vaccination
measure: 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
timeFrame: 180 days post-vaccination
measure: 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
timeFrame: 180 days post-vaccination
Other outcomes:
Locations:
city: Mobile
country: United States
facility: 4022 - Coastal Clinical Research, an AMR company
state: Alabama
city: Tempe
country: United States
facility: 4002 - Clinical Research Consortium, an AMR company
state: Arizona
city: Jacksonville
country: United States
facility: 4006 - Westside Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: 4013 - Jacksonville Center for Clinical Research
state: Florida
city: Oakland
country: United States
facility: 4021 - Research Centers of America, LLC
state: Florida
city: Boise
country: United States
facility: 4023 - Advanced Clinical Research
state: Idaho
city: Newton
country: United States
facility: 4010 - Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: 4016 - Heartland Research Associates, LLC - An AMR Company
state: Kansas
city: Lexington
country: United States
facility: 4001 - Central Kentucky Research Associates, an AMR company
state: Kentucky
city: Kenner
country: United States
facility: 4014 - Medpharmi
state: Louisiana
city: Kansas City
country: United States
facility: 4008 - The Center for Pharmaceutical Research, an AMR company
state: Missouri
city: Saint Louis
country: United States
facility: 4024 - Sundance Clinical Research, LLC
state: Missouri
city: Omaha
country: United States
facility: 4009 - Meridian Clinical Research, LLC
state: Nebraska
city: Binghamton
country: United States
facility: 4007 - Regional Clinical Research / United Medical Associates
state: New York
city: Raleigh
country: United States
facility: 4012 - M3 Wake Research, Inc.
state: North Carolina
city: Cincinnati
country: United States
facility: 4004 - Sterling research
state: Ohio
city: Cleveland
country: United States
facility: 4017 - Rapid Medical Research, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: 4011 - Lynn Health Science Institute
state: Oklahoma
city: San Antonio
country: United States
facility: 4005 - Clinical Trials of Texas, Inc.
state: Texas
city: Tomball
country: United States
facility: 4018 - Martin Diagnostic Clinic
state: Texas
city: West Jordan
country: United States
facility: 4020 - Advanced Clinical Research
state: Utah
Study officials:
affiliation: Seqirus
name: Clinical Program Director
role: STUDY_DIRECTOR
References: