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COMPLETED
NCT05501561
PHASE2

Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults ≥50 Years of Age

Sponsor: Seqirus

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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