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

PHASE2CompletedINTERVENTIONAL
Enrollment

1,056

Participants

Timeline

Start Date

August 25, 2022

Primary Completion Date

March 31, 2023

Study Completion Date

March 31, 2023

Conditions
Influenza, Human
Interventions
BIOLOGICAL

Experimental: IIV-A Investigational IIV-A will be administered as a single dose intramuscularly on Day 1

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

Experimental: aIIV-B Investigational aIIV-B will be administered as a single dose intramuscularly on Day 1

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

Experimental: aIIV-C Investigational aIIV-C will be administered as a single dose intramuscularly on Day 1

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

Active Comparator: Licensed IIV IIV will be administered as a single dose intramuscularly on Day 1

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.

Trial Locations (47)

13057

Velocity Clinical Research - Syracuse, Syracuse

13760

Meridian Clinical Research, LLC, Endwell

13901

Meridian Clinical Research (Binghamton, NY), Binghamton

20190

CVS pharmacy - Reston, Reston

20854

Rockville Internal Medicine Group, Rockville

22902

CVS pharmacy - Charlottesville, Charlottesville

23235

CVS pharmacy - Richmond, Richmond

27612

M3 Wake Research, Inc., Raleigh

29303

Velocity Clinical Research, Spartanburg, Spartanburg

29340

Velocity Clinical Research, Gaffney, Gaffney

29615

Velocity Clinical Research - Greenville, Greenville

31405

Platinum Research Network, LLC, Savannah

31406

Meridian Clinical Research - Savannah, Savannah

32132

Velocity Clinical Research - New Smyrna Beach, Edgewater

33016

Global Health Research Center, Miami Lakes

33024

CenExel RCA, Hollywood

33351

Precision Clinical Research, Sunrise

33458

Health Awareness INC, Jupiter

33615

Global Health Research Center, Tampa

33756

Innovative Research of West Florida, Inc., Clearwater

37920

AMR Coastal Clinical Research, Knoxville

39531

MedPharmics LLC, Biloxi

40509

AMR Lexington, Lexington

43213

Aventiv Research, Inc. Columbus, Columbus

45219

Meridian Clinical Research, LLC, Cincinnati

45246

Meridian Clinical Research, LLC, Cincinnati

57049

Meridian Clinical Research - Dakota Dunes, Dakota Dunes

63042

Healthcare Research Network, Hazelwood

63141

Sundance Clinical Research, LLC, St Louis

64114

The Center for Pharmaceutical Research, Kansas City

67042

AMR El Dorado, El Dorado

68005

Meridian Clinical Research, Bellevue

68510

Meridian Clinical Research, LLC, Lincoln

68803

Meridian Clinical Research, Grand Island

70006

Medpharmics, LLC, Metairie

70808

Meridian Clinical Research, Baton Rouge

73112

Lynn Health Science Institute, Oklahoma City

77375

DM Clinical Research, Tomball

80920

The Lynn Institute of The Rockies, Colorado Springs

84088

Velocity Clinical Research - West Jordan, West Jordan

84107

JBR Clinical Research, Salt Lake City

85281

AMR Tempe, Tempe

89119

Alliance for Multispecialty Research, LLC, Las Vegas, Las Vegas

92123

California Research Center, San Diego

92647

Marvel Clinical Research, Huntington Beach

97504

Velocity Clinical Research - Medford, Medford

06460

Clinical Research Consulting, LLC, Milford

All Listed Sponsors
lead

Seqirus

INDUSTRY