Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults ≥50 Years of Age
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
1 other identifier
interventional
1,056
1 country
47
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2022
Shorter than P25 for phase_2
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2022
CompletedFirst Posted
Study publicly available on registry
August 15, 2022
CompletedStudy Start
First participant enrolled
August 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedApril 3, 2024
March 1, 2024
7 months
August 11, 2022
March 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Immunogenicity Endpoint: Hemagglutination inhibition (HI) titers against vaccine A and B influenza strains
28 days post-vaccination
The Percentage of Subjects with Solicited Local and Systemic Reactions
7 days post-vaccination
The Percentage of Subjects with Unsolicited Adverse Events
28 days post-vaccination
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)
180 days post-vaccination
Secondary Outcomes (1)
Immunogenicity Endpoint: Microneutralization (MN) titers against vaccine A and B influenza strains
28 days post-vaccination
Study Arms (4)
IIV-A Investigational
EXPERIMENTALaIIV-B Investigational
EXPERIMENTALaIIV-C Investigational
EXPERIMENTALLicensed IIV
ACTIVE COMPARATORInterventions
Biological/Vaccine: Investigational IIV-A Investigational 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.
Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted 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.
Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted 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.
Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted 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.
Eligibility Criteria
You may qualify if:
- Individuals ≥50 years of age 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 for at least 2 months after the study vaccination.
- Progressive, unstable or uncontrolled clinical conditions.
- Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study.
- History of any medical condition considered an adverse event of special interest (AESI).
- 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.
- Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
- Receipt of an investigational or non-registered medicinal product within 30 days prior to informed consent.
- 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
- 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.
- Study personnel or immediate family or household member of study personnel.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seqiruslead
Study Sites (47)
AMR Tempe
Tempe, Arizona, 85281, United States
Marvel Clinical Research
Huntington Beach, California, 92647, United States
California Research Center
San Diego, California, 92123, United States
The Lynn Institute of The Rockies
Colorado Springs, Colorado, 80920, United States
Clinical Research Consulting, LLC
Milford, Connecticut, 06460, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
Velocity Clinical Research - New Smyrna Beach
Edgewater, Florida, 32132, United States
CenExel RCA
Hollywood, Florida, 33024, United States
Health Awareness INC
Jupiter, Florida, 33458, United States
Global Health Research Center
Miami Lakes, Florida, 33016, United States
Precision Clinical Research
Sunrise, Florida, 33351, United States
Global Health Research Center
Tampa, Florida, 33615, United States
Platinum Research Network, LLC
Savannah, Georgia, 31405, United States
Meridian Clinical Research - Savannah
Savannah, Georgia, 31406, United States
AMR El Dorado
El Dorado, Kansas, 67042, United States
AMR Lexington
Lexington, Kentucky, 40509, United States
Meridian Clinical Research
Baton Rouge, Louisiana, 70808, United States
Medpharmics, LLC
Metairie, Louisiana, 70006, United States
Rockville Internal Medicine Group
Rockville, Maryland, 20854, United States
MedPharmics LLC
Biloxi, Mississippi, 39531, United States
Healthcare Research Network
Hazelwood, Missouri, 63042, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Sundance Clinical Research, LLC
St Louis, Missouri, 63141, United States
Meridian Clinical Research
Bellevue, Nebraska, 68005, United States
Meridian Clinical Research
Grand Island, Nebraska, 68803, United States
Meridian Clinical Research, LLC
Lincoln, Nebraska, 68510, United States
Alliance for Multispecialty Research, LLC, Las Vegas
Las Vegas, Nevada, 89119, United States
Meridian Clinical Research (Binghamton, NY)
Binghamton, New York, 13901, United States
Meridian Clinical Research, LLC
Endwell, New York, 13760, United States
Velocity Clinical Research - Syracuse
Syracuse, New York, 13057, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612, United States
Meridian Clinical Research, LLC
Cincinnati, Ohio, 45219, United States
Meridian Clinical Research, LLC
Cincinnati, Ohio, 45246, United States
Aventiv Research, Inc. Columbus
Columbus, Ohio, 43213, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Velocity Clinical Research - Medford
Medford, Oregon, 97504, United States
Velocity Clinical Research, Gaffney
Gaffney, South Carolina, 29340, United States
Velocity Clinical Research - Greenville
Greenville, South Carolina, 29615, United States
Velocity Clinical Research, Spartanburg
Spartanburg, South Carolina, 29303, United States
Meridian Clinical Research - Dakota Dunes
Dakota Dunes, South Dakota, 57049, United States
AMR Coastal Clinical Research
Knoxville, Tennessee, 37920, United States
DM Clinical Research
Tomball, Texas, 77375, United States
JBR Clinical Research
Salt Lake City, Utah, 84107, United States
Velocity Clinical Research - West Jordan
West Jordan, Utah, 84088, United States
CVS pharmacy - Charlottesville
Charlottesville, Virginia, 22902, United States
CVS pharmacy - Reston
Reston, Virginia, 20190, United States
CVS pharmacy - Richmond
Richmond, Virginia, 23235, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
August 11, 2022
First Posted
August 15, 2022
Study Start
August 25, 2022
Primary Completion
March 31, 2023
Study Completion
March 31, 2023
Last Updated
April 3, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- SEQIRUS discloses results from clinical studies within 12 months of completion of the study 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 CTD modules submitted to regulatory agencies for public release. Summary results disclosure is either in document form (e.g., 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 \[EU CTR\])