Clinical trial NCT05501561: Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults ≥50 Years of Age
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza, Human
Keywords: influenza, vaccine, MF59, adjuvant
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2022-08-15
Enrollment: 1056
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, 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.


Eligibility criteria: 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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Primary outcomes:
measure: Immunogenicity Endpoint: Hemagglutination inhibition (HI) titers against vaccine A and B influenza strains
timeFrame: 28 days post-vaccination
measure: The Percentage of Subjects with Solicited Local and Systemic Reactions
timeFrame: 7 days post-vaccination
measure: The Percentage of Subjects with Unsolicited Adverse Events
timeFrame: 28 days post-vaccination
measure: 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)
timeFrame: 180 days post-vaccination
Secondary outcomes:
measure: Immunogenicity Endpoint: Microneutralization (MN) titers against vaccine A and B influenza strains
timeFrame: 28 days post-vaccination
Other outcomes:
Locations:
city: Tempe
country: United States
facility: AMR Tempe
state: Arizona
city: Huntington Beach
country: United States
facility: Marvel Clinical Research
state: California
city: San Diego
country: United States
facility: California Research Center
state: California
city: Colorado Springs
country: United States
facility: The Lynn Institute of The Rockies
state: Colorado
city: Milford
country: United States
facility: Clinical Research Consulting, LLC
state: Connecticut
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Edgewater
country: United States
facility: Velocity Clinical Research - New Smyrna Beach
state: Florida
city: Hollywood
country: United States
facility: CenExel RCA
state: Florida
city: Jupiter
country: United States
facility: Health Awareness INC
state: Florida
city: Miami Lakes
country: United States
facility: Global Health Research Center
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: Tampa
country: United States
facility: Global Health Research Center
state: Florida
city: Savannah
country: United States
facility: Platinum Research Network, LLC
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research - Savannah
state: Georgia
city: El Dorado
country: United States
facility: AMR El Dorado
state: Kansas
city: Lexington
country: United States
facility: AMR Lexington
state: Kentucky
city: Baton Rouge
country: United States
facility: Meridian Clinical Research
state: Louisiana
city: Metairie
country: United States
facility: Medpharmics, LLC
state: Louisiana
city: Rockville
country: United States
facility: Rockville Internal Medicine Group
state: Maryland
city: Biloxi
country: United States
facility: MedPharmics LLC
state: Mississippi
city: Hazelwood
country: United States
facility: Healthcare Research Network
state: Missouri
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Bellevue
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Grand Island
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Lincoln
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Alliance for Multispecialty Research, LLC, Las Vegas
state: Nevada
city: Binghamton
country: United States
facility: Meridian Clinical Research (Binghamton, NY)
state: New York
city: Endwell
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Syracuse
country: United States
facility: Velocity Clinical Research - Syracuse
state: New York
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Cincinnati
country: United States
facility: Meridian Clinical Research, LLC
state: Ohio
city: Cincinnati
country: United States
facility: Meridian Clinical Research, LLC
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research, Inc. Columbus
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Medford
country: United States
facility: Velocity Clinical Research - Medford
state: Oregon
city: Gaffney
country: United States
facility: Velocity Clinical Research, Gaffney
state: South Carolina
city: Greenville
country: United States
facility: Velocity Clinical Research - Greenville
state: South Carolina
city: Spartanburg
country: United States
facility: Velocity Clinical Research, Spartanburg
state: South Carolina
city: Dakota Dunes
country: United States
facility: Meridian Clinical Research - Dakota Dunes
state: South Dakota
city: Knoxville
country: United States
facility: AMR Coastal Clinical Research
state: Tennessee
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research - West Jordan
state: Utah
city: Charlottesville
country: United States
facility: CVS pharmacy - Charlottesville
state: Virginia
city: Reston
country: United States
facility: CVS pharmacy - Reston
state: Virginia
city: Richmond
country: United States
facility: CVS pharmacy - Richmond
state: Virginia
Study officials:
References: