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
A Phase 3/3b, Randomized, Observer-blind, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of Fluad and Fluad Quadrivalent Compared to a Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of Age
1 other identifier
interventional
35,800
21 countries
254
Brief Summary
This Phase 3 study is a randomized, observer-blind study of MF59-adjuvanted influenza vaccine (aQIV or aTIV) compared with a non-adjuvanted influenza vaccine (QIV or TIV) in adults ≥65 years of age. The aim of the study is to evaluate MF59-adjuvanted influenza vaccine compared with non-adjuvanted influenza vaccine in the prevention of reverse transcription-polymerase chain reaction (RT-PCR)-confirmed influenza A and/or B in subjects ≥65 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2023
Typical duration for phase_3
254 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2023
CompletedFirst Posted
Study publicly available on registry
October 18, 2023
CompletedStudy Start
First participant enrolled
October 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 24, 2026
April 1, 2026
3 years
September 28, 2023
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition
ILI = influenza-like illness; RT-PCR = reverse transcription-polymerase chain reaction
From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for Northern Hemisphere [NH] influenza season and end of November for Southern Hemisphere [SH] influenza season)
Secondary Outcomes (14)
Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition
From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season)
Efficacy Endpoint: First-occurrence of culture-confirmed influenza, due to influenza Type A and/or B virus antigenically matched to the vaccine strains selected for the seasonal vaccine, using the protocol-defined ILI definition
From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season)
Efficacy Endpoint: First-occurrence of culture-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition
From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season)
Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the modified CDC ILI definition
From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season)
Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the WHO ILI definition
From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season)
- +9 more secondary outcomes
Study Arms (2)
MF59-adjuvanted influenza vaccine
EXPERIMENTALMF59-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains or MF59-adjuvanted TIV containing 2 influenza type A strains and 1 influenza type B strain
Non-adjuvanted influenza vaccine
OTHERNon-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains or Non-adjuvanted TIV containing 2 influenza type A strains and 1 influenza type B strain
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Adults of ≥65 years of age on the day of vaccination.
- Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- Individuals who have the ability to comply with study procedures including follow-up.
You may not qualify if:
- Bedridden subjects (i.e. confined to bed by sickness or old age).
- Subjects that are incapacitated and because of that in need of a Legally Authorized Representative.
- Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study.
- Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study, or severe allergic reaction (e.g. anaphylaxis) to previous influenza vaccination.
- Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
- Clinical conditions representing a contra-indication 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 ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent; Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted;
- 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 any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the study vaccination, or planned use during the entire study period.
- Acute (severe) febrile illness.
- Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
- Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seqiruslead
Study Sites (254)
84046-Accel Research Sites - Birmingham
Birmingham, Alabama, 35216, United States
84075-Cullman Clinical Trials
Cullman, Alabama, 35055, United States
84112-DM Clinical Research - Phoenix
Phoenix, Arizona, 85012, United States
84114-Scottsdale Clinical Trials
Scottsdale, Arizona, 85260, United States
84045-Lynn Institute of the Ozarks
Little Rock, Arkansas, 72204, United States
84070-Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205, United States
84101-West Coast Research LLC
Dublin, California, 94568, United States
84124-Leading Edge Research
Encino, California, 91316, United States
84104-Zillan Clinical Research
Inglewood, California, 90303, United States
84105-Eximia Research - CA
La Mesa, California, 91942, United States
84107-Long Beach Research Institute
Long Beach, California, 90805, United States
84109-Long Beach Clinical Trials
Long Beach, California, 90806, United States
84115-Central Valley Research
Modesto, California, 95350, United States
84120-Paradigm Research
Redding, California, 96001, United States
84119-Apex Clinical Research
San Diego, California, 92120, United States
84125-Lynn Institute of Denver
Aurora, Colorado, 80012, United States
84110-Tekton Research
Longmont, Colorado, 80501, United States
84123-Paradigm Research
Wheat Ridge, Colorado, 80033, United States
84085-Clinical Research Consulting, LLC
Milford, Connecticut, 06460, United States
84017-Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
84029-Imagine Research of Palm Beach County
Boynton Beach, Florida, 33435, United States
84067-Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
84006-Nature Coast Clinical Research - Crystal River
Crystal River, Florida, 34429, United States
84012-Evolution Clinical Trials
Doral, Florida, 33122, United States
84016-USA and International Research Inc.
Doral, Florida, 33126, United States
84061-Velocity Clinical Research - New Smyrna Beach
Edgewater, Florida, 32132, United States
84065-Fleming Island Center for Clinical Research
Fleming Island, Florida, 32003, United States
84027-SIMEDHealth, LLC
Gainesville, Florida, 32607, United States
84019-Green Leaf Clinical Trials
Jacksonville, Florida, 32258, United States
84026-Health Awareness, Inc.
Jupiter, Florida, 33458, United States
84071-3SYNC Research
Lake Worth, Florida, 33460, United States
84083-Accel Research Sites Network - St. Petersburg-Largo
Largo, Florida, 33777, United States
84082-Global Health Research Center, Inc.
Miami Lakes, Florida, 33016, United States
84081-Suncoast Research Associates, LLC
Pembroke Pines, Florida, 33024, United States
84024-St. Johns Center for Clinical Research
Saint Augustine, Florida, 32086, United States
84051-Precision Clinical Research
Sunrise, Florida, 33351, United States
84008-Global Health Research Center, Inc. - Tampa
Tampa, Florida, 33615, United States
84037-Eximia Research - GA
Atlanta, Georgia, 30315, United States
84086-Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30328-6124, United States
84054-Centricity Research Columbus
Columbus, Georgia, 31904, United States
84013-M3 Wake Research/Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30103, United States
84069-Velocity Clinical Research - Savannah
Savannah, Georgia, 31406, United States
84039-North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
84118-Velocity Clinical Research - Boise
Meridian, Idaho, 83642, United States
84060-Great Lakes Clinical Trials LLC, dba Flourish Research
Chicago, Illinois, 60640, United States
84022-DM Clinical Research - River Forest
Melrose Park, Illinois, 60160, United States
84025-Velocity Clinical Research - Valparaiso
Valparaiso, Indiana, 46383, United States
84042-Velocity Clinical Research - Sioux City
Sioux City, Iowa, 51106, United States
84055-Velocity Clinical Research - Baton Rouge
Baton Rouge, Louisiana, 70809, United States
84088-Velocity Clinical Research - Covington
Covington, Louisiana, 70433, United States
84052-Velocity Clinical Research - Lafayette
Lafayette, Louisiana, 70508, United States
84064-Benchmark Research
Metairie, Louisiana, 70006, United States
84005-DM Clinical Research - Brookline
Brookline, Massachusetts, 02446, United States
84002-ActivMed Practices and Research, LLC
Methuen, Massachusetts, 01844, United States
84044-Clarkston Medical Group
Clarkston, Michigan, 48346, United States
84018-Quest Research Institute
Farmington Hills, Michigan, 48334, United States
84032-Bioscope Clinical Research, LLC
Farmington Hills, Michigan, 48336, United States
84001-Revival Research Institute, LLC
Southfield, Michigan, 48075, United States
84074-DM Clinical Research - Southfield
Southfield, Michigan, 48076, United States
84023-Velocity Clinical Research - Gulfport
Gulfport, Mississippi, 39503, United States
84038-Kansas City Research Institute
Kansas City, Missouri, 64131, United States
84057-Sundance Clinical Research
St Louis, Missouri, 63141, United States
84108-Boeson Research MSO
Missoula, Montana, 59804, United States
84030-Velocity Clinical Research - Grand Island
Grand Island, Nebraska, 68803, United States
84040-Velocity Clinical Research - Norfolk
Norfolk, Nebraska, 68701, United States
84007-Velocity Clinical Research - Omaha
Omaha, Nebraska, 68134, United States
84117-M3 Wake Research/CRCN
Las Vegas, Nevada, 89106, United States
84103-Alliance for Multispecialty Research, LLC
Las Vegas, Nevada, 89119, United States
84111-Vector Clinical Trials
Las Vegas, Nevada, 89128, United States
84106-Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030, United States
84003-DM Clinical Research - New Jersey
Jersey City, New Jersey, 07306, United States
84122-Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
84048-Velocity Clinical Research - Binghamton
Binghamton, New York, 13905, United States
84077-Velocity Clinical Research - Syracuse
East Syracuse, New York, 13057, United States
84014-Asheville Clinical Research
Asheville, North Carolina, 28803, United States
84089-Velocity Clinical Research - Durham
Durham, North Carolina, 27701, United States
84035-Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
84102-Eximia Research - NC
Raleigh, North Carolina, 27607, United States
84020-M3 Wake Research/Raleigh Clinical Research, LLC
Raleigh, North Carolina, 27612, United States
84004-TMA Headlands LLC, dba Trial Management Associates
Wilmington, North Carolina, 28403, United States
84079-Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, 27103, United States
84021-Velocity Clinical Research - Cleveland
Beachwood, Ohio, 44122, United States
84034-CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
84063-Velocity Clinical Research - Cincinnati (Mt. Auburn)
Cincinnati, Ohio, 45219, United States
84078-Tekton Research
Yukon, Oklahoma, 73099, United States
84121-Velocity Clinical Research - Medford
Medford, Oregon, 97504, United States
84050-3SYNC Research
Pittsburgh, Pennsylvania, 15241, United States
84009-Velocity Clinical Research - Providence
East Greenwich, Rhode Island, 02818, United States
84010-M3 Wake Research/Charleston Clinical Trials, LLC
Charleston, South Carolina, 29414, United States
84043-Velocity Clinical Research - Gaffney
Gaffney, South Carolina, 29340, United States
84056-Coastal Carolina Research Center, LLC
North Charleston, South Carolina, 29405, United States
84047-Velocity Clinical Research - Spartanburg
Spartanburg, South Carolina, 29303, United States
84053-Velocity Clinical Research - Union
Union, South Carolina, 29379, United States
84068-WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
84090-Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37909, United States
84084-Clinical Research Associates, Inc.
Nashville, Tennessee, 37203, United States
84072-WR-Global Medical Research, LLC
Dallas, Texas, 75224, United States
84028-Benchmark Research
Fort Worth, Texas, 76135, United States
84015-Trio Clinical Trials LLC
Houston, Texas, 77008, United States
84062-Activian Clinical Research
Kingwood, Texas, 77339, United States
84080-ACRC Trials
Plano, Texas, 75024, United States
84031-North Texas Family Medicine
Plano, Texas, 75093, United States
84066-Research Your Health
Plano, Texas, 75093, United States
84011-Clinical Trials of Texas, LLC, dba Flourish Research
San Antonio, Texas, 78229, United States
84076-DM Clinical Research - San Antonio
San Antonio, Texas, 78257, United States
84059-DM Clinical Research - Sugar Land
Sugar Land, Texas, 77478, United States
84087-DM Clinical Research - Tomball
Tomball, Texas, 77375, United States
84049-Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
84058-Clinical Research Partners
Richmond, Virginia, 23226, United States
84036-Velocity Clinical Research - Suffolk
Suffolk, Virginia, 23435, United States
84113-DM Clinical Research - Seattle
Seattle, Washington, 98122, United States
03603-University of the Sunshine Coast
Birtinya, Australia
03609-Paratus Clinical Western Sydney
Blacktown, Australia
03605-Emeritus Research - Sydney
Botany, Australia
03614-Northern Beaches Clinical Research
Brookvale, Australia
03602-Emeritus Research - Melbourne
Camberwell, Australia
03615-Momentum Clinical Research Darlinghurst
Darlinghurst, Australia
03608-Paratus Clinical Brisbane
Herston, Australia
03610-Paratus Clinical Central Coast
Kanwal, Australia
03604-Doherty Clinical Trials Limited
Melbourne, Australia
03611-Nucleus Network
Melbourne, Australia
03601-University of the Sunshine Coast - Morayfield
Morayfield, Australia
03607-University of the Sunshine Coast - South Bank
South Brisbane, Australia
03613-Momentum Clinical Research Taringa
Taringa, Australia
03612-Wollongong Clinical Reserach
Wollongong, Australia
05605-AZ Sint-Jan Brugge-Oostende - Campus Sint-Jan
Bruges, Belgium
05602-Universitair Ziekenhuis Gent
Ghent, Belgium
05603-Medif BVBA
Gozée, Belgium
05601-Jan Yperman Ziekenhuis
Ieper, Belgium
10005-MHAT Dr. Tota Venkova
Gabrovo, Bulgaria
10018-Medical Center - Zdrave-1
Kozloduy, Bulgaria
10029-Medical Centre Leo Clinic EOOD
Lovech, Bulgaria
10007-Medical Center Hera EOOD
Montana, Bulgaria
10014-Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD
Montana, Bulgaria
10032-MHAT Zdrave
Pazardzhik, Bulgaria
10019-MC Med Consult Pleven
Pleven, Bulgaria
10022-Ambulatory Outpatient Medical Practice for First Patient Care Zaprin Pepelov
Plovdiv, Bulgaria
10024-UMHAT Pulmed
Plovdiv, Bulgaria
10026-Multiprofile Hospital for Active Treatment Sv. Panteleymon - Plovdiv
Plovdiv, Bulgaria
10031-Medical Centre Pratia Clinic EOOD
Plovdiv, Bulgaria
10004-Medical Center Prolet EOOD
Rousse, Bulgaria
10012-Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse EOOD
Rousse, Bulgaria
10016-Medical Center 1 - Sevlievo EOOD
Sevlievo, Bulgaria
10023-DCC-1 Sliven
Sliven, Bulgaria
10006-DCC 22 - Sofia
Sofia, Bulgaria
10015-Medical Center Hera - Pulmonology Office
Sofia, Bulgaria
10021-Medical Center Intermedica
Sofia, Bulgaria
10028-Medical Center Excelsior OOD
Sofia, Bulgaria
10030-Diagnostic-Consultative Centre Ascendent EOOD
Sofia, Bulgaria
10027-AIPPMP D-r Zhaneta Demireva
Stamboliyski, Bulgaria
20307-CCR Brno s.r.o.
Brno, Czechia
20305-Centrum ockovani a cestovni mediciny
České Budějovice, Czechia
20306-ADMED, s.r.o.
České Budějovice, Czechia
20311-Ordinace Hradebni s.r.o
České Budějovice, Czechia
20310-MUDr. Jakub Strincl, s.r.o.
Liberec, Czechia
20309-CCR Ostrava, s.r.o.
Ostrava, Czechia
20308-MUDr. Jakub Strincl, s.r.o.
Protivín, Czechia
20312-MEDISON s.r.o.
Přeštice, Czechia
24603-Helsinki South Vaccine Research Clinic
Helsinki, Finland
24602-Oulu Vaccine Research Clinic
Oulu, Finland
24601-Tampere Vaccine Research Clinic
Tampere, Finland
24604-Turku Vaccine Research Clinic
Turku, Finland
26803-UNIMED Adjara LTD - Batumi Referral Hospital
Batumi, Georgia
26801-LTD Hospital Service
Kutaisi, Georgia
26802-Acad. G. Chapidze Emergency Cardiology Center
Tbilisi, Georgia
26804-K. Eristavi National Center of Clinical Surgery
Tbilisi, Georgia
38003-Policlinico Bari
Bari, Italy
38001-PO A. Manzoni di Lecco, ASST Lecco
Lecco, Italy
38004-Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco
Milan, Italy
44004-JSC InMedica
Kaunas, Lithuania
44008-JSC Saulės Šeimos Medicinos Centras
Kaunas, Lithuania
44009-Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, Lithuania
44010-InlitaJSC Santara CTC
Vilnius, Lithuania
52802-Emotional Brain BV
Almere Stad, Netherlands
52804-Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care
Utrecht, Netherlands
55404-Optimal Clinical Trials - Central
Grafton, New Zealand
55402-Momentum Clinical Research Wellington
Mount Cook, New Zealand
55405-Pacific Clinical Research Network - West Auckland
New Lynn, New Zealand
55403-Optimal Clinical Trials - North
Rosedale, New Zealand
55401-PCRN - Auckland
Takapuna, New Zealand
60812-Health Index Multispecialty and Lying-In Clinic
Bacoor, Philippines
60813-Norzel Medical and Diagnostic Clinic
Cebu, Philippines
60808-CT CARE Group
Dasmariñas, Philippines
60801-Davao Doctors Hospital
Davao City, Philippines
60802-West Visayas State University Medical Center
Iloilo City, Philippines
60815-St Paul's Hospital Iloilo
Iloilo City, Philippines
60816-St Paul's Hospital Iloilo
Iloilo City, Philippines
60803-Philippine General Hospital
Manila, Philippines
60811-Philippine General Hospital
Manila, Philippines
60814-Manila Doctors Hospital
Manila, Philippines
60804-St. Michael Family Hospital
Marilao, Philippines
60805-San Juan de Dios Hospital
Pasay, Philippines
60806-Quirino Memorial Medical Center
Quezon City, Philippines
60817-Silang Specialist Medical Center
Silang, Philippines
61619-Krakowskie Centrum Medyczne Sp. z o.o
Krakow, Poland
61618-Centrum Medyczne AMED Oddzial w Lodzi
Lodz, Poland
61622-KOMED Nova Lublin II
Lublin, Poland
61620-KOMED Nova Pulawy
Puławy, Poland
61614-KO-MED Centra Kliniczne Staszow
Staszów, Poland
61605-RCMed Oddział Warszawa
Warsaw, Poland
61615-ETG Warszawa
Warsaw, Poland
61616-MTZ Clinical Research
Warsaw, Poland
61621-Futuremed Warszawa Centrum
Warsaw, Poland
61617-Przychodnia FutureMeds Wroclaw
Wroclaw, Poland
61623-KOMED Nova Zamosc
Zamość, Poland
64210-Sana Monitoring
Bucharest, Romania
64204-Ames Research Center
Calarasi, Romania
64208-Spitalul Municipal Caracal
Caracal, Romania
64209-Clintrial Medical Center
Reșca, Romania
64211-Nova-Clin Medical Research Center
Timișoara, Romania
68803-Clinical Center of Serbia
Belgrade, Serbia
68805-Clinical Hospital Center Zemun
Belgrade, Serbia
68806-CHC Bezanijska Kosa
Belgrade, Serbia
68802-Institute for Pulmonary Disease of Vojvodina
Kamenitz, Serbia
68804-General Hospital Valjevo
Valjevo, Serbia
71007-Josha Research Center
Bloemfontein, South Africa
71008-Madibeng Centre for Research
Brits, South Africa
71011-University of Cape Town Lung Institute
Cape Town, South Africa
71014-TREAD Research
Cape Town, South Africa
71015-Tiervlei Trial Centre
Cape Town, South Africa
71001-Ubuntu Clinical Research Krugersdorp
Krugersdorp, South Africa
71010-Merclinico Middelburg
Middelburg, South Africa
71009-Newtown Clinical Research Centre
Newtown, South Africa
71005-Be Part Research
Paarl, South Africa
71013-Into Research, Life Groenkloof Hospital
Pretoria, South Africa
71003-Tsitsikamma Clinical Research Initiative
Thabazimbi, South Africa
71004-FCRN Clinical Trials Centre
Vereeniging, South Africa
41002-Korea University Ansan Hospital
Ansan, South Korea
41001-Inha University Hospital
Incheon, South Korea
41004-Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea
41005-Korea University Guro Hospital
Seoul, South Korea
41003-Ajou University Hospital
Suwon, South Korea
72402-EAP Vic - CAP El Remei
Barcelona, Spain
72407-Futurmeds Spain Cadiz
Cadiz, Spain
72405-Futuremeds Spain Madrid
Madrid, Spain
72404-Hospital Universitario Son Espases
Palma de Mallorca, Spain
72403-Complexo Hospitalario Universitario De Santiago
Santiago de Compostela, Spain
72406-Futuremeds Spain Sevilla
Seville, Spain
72401-Hospital Povisa
Vigo, Spain
15803-Taipei Medical University - Shuang Ho Hospital
New Taipei City, Taiwan
15801-China Medical University Hospital
Taichung, Taiwan
15802-National Cheng Kung University Hospital
Tainan, Taiwan
15804-Taipei Medical University - Wanfang Hospital
Taipei, Taiwan
15805-Taipei Medical University
Taipei, Taiwan
79209-Hacettepe University Faculty of Medicine
Ankara, Turkey (Türkiye)
79207-Akdeniz University Faculty of Medicine
Antalya, Turkey (Türkiye)
79212-Dicle Universitesi Tip Fakultesi
Diyarbakır, Turkey (Türkiye)
79205-Goztepe Suleyman Yalcin City Hospital
Istanbul, Turkey (Türkiye)
791210-Dokuz Eylul University Faculty of Medicine
Izmir, Turkey (Türkiye)
79208-Izmir Dr. Suat Seren Pulmonary Hospital
Izmir, Turkey (Türkiye)
79213-Ege University Hospital
Izmir, Turkey (Türkiye)
79204 - Kocaeli University Faculty of Medicine
Kocaeli, 41380, Turkey (Türkiye)
79211-Karadeniz Technical University Faculty of Medicine
Trabzon, Turkey (Türkiye)
71601-Charles River Medical Group, Mutala Trust and Infectious Disease Research Laboratory
Harare, Zimbabwe
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Program Director
Seqirus
Study Design
- Study Type
- interventional
- Phase
- phase 3
- 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
September 28, 2023
First Posted
October 18, 2023
Study Start
October 23, 2023
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
- Access Criteria
- Proposed research should seek to answer a previously unanswered important medical or scientific question. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
Seqirus will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact Seqirus at seqirus.clinicaltrials@seqirus.com.