A Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Adjuvanted Influenza Vaccine Compared to a Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of Age

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

35,800

Participants

Timeline

Start Date

October 23, 2023

Primary Completion Date

November 30, 2026

Study Completion Date

December 31, 2026

Conditions
Influenza, Human
Interventions
BIOLOGICAL

aQIV or aTIV

Participants receive a 0.5-mL intramuscular dose of aQIV or aTIV on Day 1. A 0.5 mL dose of aQIV contains nominally 15 µg of hemagglutinin (HA) of each of the 2 influenza type A strains and each of the 2 influenza B strains (total of 60 µg HA). A 0.5 mL dose of aTIV contains nominally 15 µg of HA of each of the 2 influenza type A strains and of the influenza B strain (total of 45 µg HA). The strain composition of aQIV and aTIV is that recommended by the World Health Organization (WHO) for quadrivalent and trivalent influenza vaccines, respectively, contemporaneous to the timing of the study.

BIOLOGICAL

QIV or TIV

Participants receive a 0.5-mL intramuscular dose of the non-adjuvanted QIV or TIV on Day 1. A 0.5 mL dose of QIV contains nominally 15 μg of HA of each of the 2 influenza type A strains and each of the 2 influenza B strains (total of 60 μg HA). A 0.5 mL dose of TIV contains nominally 15 μg of HA of each of the 2 influenza type A strains and of the influenza B strain (total of 45 μg HA). The strain composition of QIV and TIV is that recommended by the WHO for quadrivalent and trivalent influenza vaccines, respectively, contemporaneous to the timing of the study.

Trial Locations (249)

11220

84073-DM Clinical Research - Brooklyn, Brooklyn

11226

84033-Brooklyn Clinical Research, Brooklyn

13057

84077-Velocity Clinical Research - Syracuse, East Syracuse

13905

84048-Velocity Clinical Research - Binghamton, Binghamton

15241

84050-3SYNC Research, Pittsburgh

22911

84049-Charlottesville Medical Research, Charlottesville

23226

84058-Clinical Research Partners, Richmond

23435

84036-Velocity Clinical Research - Suffolk, Suffolk

27103

84079-Progressive Medicine of the Triad, LLC, Winston-Salem

27607

84102-Eximia Research - NC, Raleigh

27612

84020-M3 Wake Research/Raleigh Clinical Research, LLC, Raleigh

27701

84089-Velocity Clinical Research - Durham, Durham

28112

84035-Monroe Biomedical Research, Monroe

28403

84004-TMA Headlands LLC, dba Trial Management Associates, Wilmington

28803

84014-Asheville Clinical Research, Asheville

29303

84047-Velocity Clinical Research - Spartanburg, Spartanburg

29340

84043-Velocity Clinical Research - Gaffney, Gaffney

29379

84053-Velocity Clinical Research - Union, Union

29414

84010-M3 Wake Research/Charleston Clinical Trials, LLC, Charleston

30103

84013-M3 Wake Research/Mount Vernon Clinical Research, LLC, Sandy Springs

30189

84039-North Georgia Clinical Research, Woodstock

30315

84037-Eximia Research - GA, Atlanta

31406

84069-Velocity Clinical Research - Savannah, Savannah

31904

84054-Centricity Research Columbus, Columbus

32003

84065-Fleming Island Center for Clinical Research, Fleming Island

32086

84024-St. Johns Center for Clinical Research, Saint Augustine

32132

84061-Velocity Clinical Research - New Smyrna Beach, Edgewater

32258

84019-Green Leaf Clinical Trials, Jacksonville

32607

84027-SIMEDHealth, LLC, Gainesville

33016

84082-Global Health Research Center, Inc., Miami Lakes

33024

84081-Suncoast Research Associates, LLC, Pembroke Pines

33122

84012-Evolution Clinical Trials, Doral

33126

84016-USA and International Research Inc., Doral

33351

84051-Precision Clinical Research, Sunrise

33435

84029-Imagine Research of Palm Beach County, Boynton Beach

33458

84026-Health Awareness, Inc., Jupiter

33460

84071-3SYNC Research, Lake Worth

33615

84008-Global Health Research Center, Inc. - Tampa, Tampa

33756

84067-Innovative Research of West Florida, Inc., Clearwater

33777

84083-Accel Research Sites Network - St. Petersburg-Largo, Largo

34429

84006-Nature Coast Clinical Research - Crystal River, Crystal River

35055

84075-Cullman Clinical Trials, Cullman

35216

84046-Accel Research Sites - Birmingham, Birmingham

37203

84084-Clinical Research Associates, Inc., Nashville

37421

84068-WR-ClinSearch, LLC, Chattanooga

37909

84090-Alliance for Multispecialty Research, LLC, Knoxville

39503

84023-Velocity Clinical Research - Gulfport, Gulfport

41380

79204 - Kocaeli University Faculty of Medicine, Kocaeli

44122

84021-Velocity Clinical Research - Cleveland, Beachwood

45212

84034-CTI Clinical Research Center, Cincinnati

45219

84063-Velocity Clinical Research - Cincinnati (Mt. Auburn), Cincinnati

46383

84025-Velocity Clinical Research - Valparaiso, Valparaiso

48075

84001-Revival Research Institute, LLC, Southfield

48076

84074-DM Clinical Research - Southfield, Southfield

48334

84018-Quest Research Institute, Farmington Hills

48336

84032-Bioscope Clinical Research, LLC, Farmington Hills

48346

84044-Clarkston Medical Group, Clarkston

51106

84042-Velocity Clinical Research - Sioux City, Sioux City

59804

84108-Boeson Research MSO, Missoula

60160

84022-DM Clinical Research - River Forest, Melrose Park

60640

84060-Great Lakes Clinical Trials LLC, dba Flourish Research, Chicago

63141

84057-Sundance Clinical Research, St Louis

64131

84038-Kansas City Research Institute, Kansas City

68134

84007-Velocity Clinical Research - Omaha, Omaha

68701

84040-Velocity Clinical Research - Norfolk, Norfolk

68803

84030-Velocity Clinical Research - Grand Island, Grand Island

70006

84064-Benchmark Research, Metairie

70433

84088-Velocity Clinical Research - Covington, Covington

70508

84052-Velocity Clinical Research - Lafayette, Lafayette

70809

84055-Velocity Clinical Research - Baton Rouge, Baton Rouge

72205

84070-Baptist Health Center for Clinical Research, Little Rock

73099

84078-Tekton Research, Yukon

75024

84080-ACRC Trials, Plano

75093

84031-North Texas Family Medicine, Plano

84066-Research Your Health, Plano

75224

84072-WR-Global Medical Research, LLC, Dallas

76135

84028-Benchmark Research, Fort Worth

77008

84015-Trio Clinical Trials LLC, Houston

77339

84062-Activian Clinical Research, Kingwood

77375

84087-DM Clinical Research - Tomball, Tomball

77478

84059-DM Clinical Research - Sugar Land, Sugar Land

78229

84011-Clinical Trials of Texas, LLC, dba Flourish Research, San Antonio

78257

84076-DM Clinical Research - San Antonio, San Antonio

80012

84125-Lynn Institute of Denver, Aurora

80033

84123-Paradigm Research, Wheat Ridge

80501

84110-Tekton Research, Longmont

83642

84118-Velocity Clinical Research - Boise, Meridian

85012

84112-DM Clinical Research - Phoenix, Phoenix

85260

84114-Scottsdale Clinical Trials, Scottsdale

87102

84122-Albuquerque Clinical Trials, Albuquerque

89030

84106-Las Vegas Clinical Trials, North Las Vegas

89106

84117-M3 Wake Research/CRCN, Las Vegas

89119

84103-Alliance for Multispecialty Research, LLC, Las Vegas

89128

84111-Vector Clinical Trials, Las Vegas

90303

84104-Zillan Clinical Research, Inglewood

90805

84107-Long Beach Research Institute, Long Beach

90806

84109-Long Beach Clinical Trials, Long Beach

91316

84124-Leading Edge Research, Encino

91942

84105-Eximia Research - CA, La Mesa

92120

84119-Apex Clinical Research, San Diego

94568

84101-West Coast Research LLC, Dublin

95350

84115-Central Valley Research, Modesto

96001

84120-Paradigm Research, Redding

97504

84121-Velocity Clinical Research - Medford, Medford

98122

84113-DM Clinical Research - Seattle, Seattle

06460

84085-Clinical Research Consulting, LLC, Milford

06708

84017-Chase Medical Research, LLC, Waterbury

30328-6124

84086-Agile Clinical Research Trials, LLC, Atlanta

02446

84005-DM Clinical Research - Brookline, Brookline

01844

84002-ActivMed Practices and Research, LLC, Methuen

07306

84003-DM Clinical Research - New Jersey, Jersey City

02818

84009-Velocity Clinical Research - Providence, East Greenwich

Unknown

03603-University of the Sunshine Coast, Birtinya

03609-Paratus Clinical Western Sydney, Blacktown

03605-Emeritus Research - Sydney, Botany

03614-Northern Beaches Clinical Research, Brookvale

03602-Emeritus Research - Melbourne, Camberwell

03615-Momentum Clinical Research Darlinghurst, Darlinghurst

03608-Paratus Clinical Brisbane, Herston

03610-Paratus Clinical Central Coast, Kanwal

03604-Doherty Clinical Trials Limited, Melbourne

03611-Nucleus Network, Melbourne

03601-University of the Sunshine Coast - Morayfield, Morayfield

03607-University of the Sunshine Coast - South Bank, South Brisbane

03613-Momentum Clinical Research Taringa, Taringa

03612-Wollongong Clinical Reserach, Wollongong

05605-AZ Sint-Jan Brugge-Oostende - Campus Sint-Jan, Bruges

05602-Universitair Ziekenhuis Gent, Ghent

05603-Medif BVBA, Gozée

05601-Jan Yperman Ziekenhuis, Ieper

10005-MHAT Dr. Tota Venkova, Gabrovo

10018-Medical Center - Zdrave-1, Kozloduy

10029-Medical Centre Leo Clinic EOOD, Lovech

10007-Medical Center Hera EOOD, Montana

10014-Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD, Montana

10032-MHAT Zdrave, Pazardzhik

10019-MC Med Consult Pleven, Pleven

10022-Ambulatory Outpatient Medical Practice for First Patient Care Zaprin Pepelov, Plovdiv

10024-UMHAT Pulmed, Plovdiv

10026-Multiprofile Hospital for Active Treatment Sv. Panteleymon - Plovdiv, Plovdiv

10031-Medical Centre Pratia Clinic EOOD, Plovdiv

10004-Medical Center Prolet EOOD, Rousse

10012-Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse EOOD, Rousse

10016-Medical Center 1 - Sevlievo EOOD, Sevlievo

10023-DCC-1 Sliven, Sliven

10006-DCC 22 - Sofia, Sofia

10015-Medical Center Hera - Pulmonology Office, Sofia

10021-Medical Center Intermedica, Sofia

10028-Medical Center Excelsior OOD, Sofia

10030-Diagnostic-Consultative Centre Ascendent EOOD, Sofia

10027-AIPPMP D-r Zhaneta Demireva, Stamboliyski

20307-CCR Brno s.r.o., Brno

20305-Centrum ockovani a cestovni mediciny, České Budějovice

20306-ADMED, s.r.o., České Budějovice

20311-Ordinace Hradebni s.r.o, České Budějovice

20310-MUDr. Jakub Strincl, s.r.o., Liberec

20309-CCR Ostrava, s.r.o., Ostrava

20308-MUDr. Jakub Strincl, s.r.o., Protivín

20312-MEDISON s.r.o., Přeštice

24603-Helsinki South Vaccine Research Clinic, Helsinki

24602-Oulu Vaccine Research Clinic, Oulu

24601-Tampere Vaccine Research Clinic, Tampere

24604-Turku Vaccine Research Clinic, Turku

26803-UNIMED Adjara LTD - Batumi Referral Hospital, Batumi

26801-LTD Hospital Service, Kutaisi

26802-Acad. G. Chapidze Emergency Cardiology Center, Tbilisi

26804-K. Eristavi National Center of Clinical Surgery, Tbilisi

38003-Policlinico Bari, Bari

38001-PO A. Manzoni di Lecco, ASST Lecco, Lecco

38004-Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco, Milan

44004-JSC InMedica, Kaunas

44008-JSC Saulės Šeimos Medicinos Centras, Kaunas

44009-Hospital of Lithuanian University of Health Sciences Kauno klinikos, Kaunas

44010-InlitaJSC Santara CTC, Vilnius

52802-Emotional Brain BV, Almere Stad

52804-Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care, Utrecht

55404-Optimal Clinical Trials - Central, Grafton

55402-Momentum Clinical Research Wellington, Mount Cook

55405-Pacific Clinical Research Network - West Auckland, New Lynn

55403-Optimal Clinical Trials - North, Rosedale

55401-PCRN - Auckland, Takapuna

60812-Health Index Multispecialty and Lying-In Clinic, Bacoor

60813-Norzel Medical and Diagnostic Clinic, Cebu

60808-CT CARE Group, Dasmariñas

60801-Davao Doctors Hospital, Davao City

60802-West Visayas State University Medical Center, Iloilo City

60815-St Paul's Hospital Iloilo, Iloilo City

60816-St Paul's Hospital Iloilo, Iloilo City

60803-Philippine General Hospital, Manila

60811-Philippine General Hospital, Manila

60814-Manila Doctors Hospital, Manila

60804-St. Michael Family Hospital, Marilao

60805-San Juan de Dios Hospital, Pasay

60806-Quirino Memorial Medical Center, Quezon City

60817-Silang Specialist Medical Center, Silang

61619-Krakowskie Centrum Medyczne Sp. z o.o, Krakow

61618-Centrum Medyczne AMED Oddzial w Lodzi, Lodz

61622-KOMED Nova Lublin II, Lublin

61620-KOMED Nova Pulawy, Puławy

61614-KO-MED Centra Kliniczne Staszow, Staszów

61605-RCMed Oddział Warszawa, Warsaw

61615-ETG Warszawa, Warsaw

61616-MTZ Clinical Research, Warsaw

61621-Futuremed Warszawa Centrum, Warsaw

61617-Przychodnia FutureMeds Wroclaw, Wroclaw

61623-KOMED Nova Zamosc, Zamość

64210-Sana Monitoring, Bucharest

64208-Spitalul Municipal Caracal, Caracal

64204-Ames Research Center, Călăraşi

64209-Clintrial Medical Center, Reșca

64211-Nova-Clin Medical Research Center, Timișoara

71007-Josha Research Center, Bloemfontein

71008-Madibeng Centre for Research, Brits

71011-University of Cape Town Lung Institute, Cape Town

71014-TREAD Research, Cape Town

71015-Tiervlei Trial Centre, Cape Town

71001-Ubuntu Clinical Research Krugersdorp, Krugersdorp

71010-Merclinico Middelburg, Middelburg

71009-Newtown Clinical Research Centre, Newtown

71005-Be Part Research, Paarl

71013-Into Research, Life Groenkloof Hospital, Pretoria

71003-Tsitsikamma Clinical Research Initiative, Thabazimbi

71004-FCRN Clinical Trials Centre, Vereeniging

41002-Korea University Ansan Hospital, Ansan

41001-Inha University Hospital, Incheon

41004-Hallym University Kangnam Sacred Heart Hospital, Seoul

41005-Korea University Guro Hospital, Seoul

41003-Ajou University Hospital, Suwon

72402-EAP Vic - CAP El Remei, Barcelona

72407-Futurmeds Spain Cadiz, Cadiz

72405-Futuremeds Spain Madrid, Madrid

72404-Hospital Universitario Son Espases, Palma de Mallorca

72403-Complexo Hospitalario Universitario De Santiago, Santiago de Compostela

72406-Futuremeds Spain Sevilla, Seville

72401-Hospital Povisa, Vigo

15803-Taipei Medical University - Shuang Ho Hospital, New Taipei City

15801-China Medical University Hospital, Taichung

15802-National Cheng Kung University Hospital, Tainan City

15804-Taipei Medical University - Wanfang Hospital, Taipei

15805-Taipei Medical University, Taipei

79209-Hacettepe University Faculty of Medicine, Ankara

79207-Akdeniz University Faculty of Medicine, Antalya

79212-Dicle Universitesi Tip Fakultesi, Diyarbakır

79205-Goztepe Suleyman Yalcin City Hospital, Istanbul

791210-Dokuz Eylul University Faculty of Medicine, Izmir

79208-Izmir Dr. Suat Seren Pulmonary Hospital, Izmir

79213-Ege University Hospital, Izmir

79211-Karadeniz Technical University Faculty of Medicine, Trabzon

71601-Charles River Medical Group, Mutala Trust and Infectious Disease Research Laboratory, Harare

All Listed Sponsors
lead

Seqirus

INDUSTRY

NCT06087640 - A Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Adjuvanted Influenza Vaccine Compared to a Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of Age | Biotech Hunter | Biotech Hunter