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Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults ≥50 Years of Age
Sponsor: Seqirus
Summary
This Phase 2, randomized, observer-blind, dose-confirmation clinical study evaluated different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 1000 subjects were randomized into 1 of 4 possible treatment groups with approximately 250 participants per group. Every participant received an influenza vaccine injection on Day 1 and were to be followed up for approximately 6 months following injection. The primary immunogenicity analysis is based on Day 29 serology data.
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
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1056
Start Date
2022-08-25
Completion Date
2023-03-31
Last Updated
2026-06-30
Healthy Volunteers
Yes
Conditions
Interventions
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1
Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher hemagglutinin \[HA\] dose), 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.
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1
Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), 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.
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1
Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), 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.
Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1
Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), 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.
Locations (47)
AMR Tempe
Tempe, Arizona, United States
Marvel Clinical Research
Huntington Beach, California, United States
California Research Center
San Diego, California, United States
The Lynn Institute of The Rockies
Colorado Springs, Colorado, United States
Clinical Research Consulting, LLC
Milford, Connecticut, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States
Velocity Clinical Research - New Smyrna Beach
Edgewater, Florida, United States
CenExel RCA
Hollywood, Florida, United States
Health Awareness INC
Jupiter, Florida, United States
Global Health Research Center
Miami Lakes, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Global Health Research Center
Tampa, Florida, United States
Platinum Research Network, LLC
Savannah, Georgia, United States
Meridian Clinical Research - Savannah
Savannah, Georgia, United States
AMR El Dorado
El Dorado, Kansas, United States
AMR Lexington
Lexington, Kentucky, United States
Meridian Clinical Research
Baton Rouge, Louisiana, United States
Medpharmics, LLC
Metairie, Louisiana, United States
Rockville Internal Medicine Group
Rockville, Maryland, United States
MedPharmics LLC
Biloxi, Mississippi, United States
Healthcare Research Network
Hazelwood, Missouri, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Meridian Clinical Research
Bellevue, Nebraska, United States
Meridian Clinical Research
Grand Island, Nebraska, United States
Meridian Clinical Research, LLC
Lincoln, Nebraska, United States
Alliance for Multispecialty Research, LLC, Las Vegas
Las Vegas, Nevada, United States
Meridian Clinical Research (Binghamton, NY)
Binghamton, New York, United States
Meridian Clinical Research, LLC
Endwell, New York, United States
Velocity Clinical Research - Syracuse
Syracuse, New York, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, United States
Meridian Clinical Research, LLC
Cincinnati, Ohio, United States
Meridian Clinical Research, LLC
Cincinnati, Ohio, United States
Aventiv Research, Inc. Columbus
Columbus, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Velocity Clinical Research - Medford
Medford, Oregon, United States
Velocity Clinical Research, Gaffney
Gaffney, South Carolina, United States
Velocity Clinical Research - Greenville
Greenville, South Carolina, United States
Velocity Clinical Research, Spartanburg
Spartanburg, South Carolina, United States
Meridian Clinical Research - Dakota Dunes
Dakota Dunes, South Dakota, United States
AMR Coastal Clinical Research
Knoxville, Tennessee, United States
DM Clinical Research
Tomball, Texas, United States
JBR Clinical Research
Salt Lake City, Utah, United States
Velocity Clinical Research - West Jordan
West Jordan, Utah, United States
CVS pharmacy - Charlottesville
Charlottesville, Virginia, United States
CVS pharmacy - Reston
Reston, Virginia, United States
CVS pharmacy - Richmond
Richmond, Virginia, United States