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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified March 2026 by Seqirus
Sponsor
Seqirus
Information Provided by (Responsible Party)
Seqirus
Clinicaltrials.gov Identifier
NCT06087640
Other Study ID Numbers:
V118_24
First Submitted
September 27, 2023
First Posted
October 17, 2023
Last Update Posted
April 23, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Influenza, Human
Biological: aQIV or aTIVBiological: QIV or TIV

Study Design

Study TypeInterventional
Actual Enrollment35800 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposePrevention
Official TitleA 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
Study Start DateOctober 22, 2023
Actual Primary Completion Date5mos 3w from now
Actual Study Completion Date6mos 3w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
MF59-adjuvanted influenza vaccine
MF59-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
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.
Non-adjuvanted influenza vaccine
Non-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
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.

Outcome Measures

Primary Outcome Measures
  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
Secondary Outcome Measures
  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
  2. 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
  3. 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
  4. 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
    CDC = Centers for Disease Control and Prevention
  5. 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
    WHO = World Health Organization
  6. Efficacy Endpoint: First-occurrence of culture-confirmed influenza, due to influenza Type A and/or B virus antigenically unmatched to the vaccine strains selected for the seasonal vaccine, using the protocol-defined ILI definition
  7. Immunogenicity Endpoint: Pre- and post-vaccination hemagglutination inhibition (HI) geometric mean titers (GMTs) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
  8. Immunogenicity Endpoint: Geometric mean fold increase (GMFI, Day 22/Day1) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
  9. Immunogenicity Endpoint: Percentage of subjects achieving seroconversion for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
    Seroconversion is defined as the percentage of subjects with either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a ≥4-fold increase in post-vaccination titer.
  10. Immunogenicity Endpoint: Percentage of subjects with HI titer ≥1:40 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
  11. Safety Endpoint: All adverse events (AEs) reported within 30 minutes after vaccination
  12. Safety Endpoint: Serious adverse events (SAEs) reported during the entire study period
  13. Safety Endpoint: Adverse events of special interest (AESIs) reported during the entire study period
  14. Safety Endpoint: AEs leading to premature withdrawal from the study during the entire study period

Eligibility Criteria

Ages Eligible for Study(Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
Inclusion Criteria
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described. 1. Adults of ≥65 years of age on the day of vaccination. 2. 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. 3. Individuals who have the ability to comply with study procedures including follow-up.
Exclusion Criteria
In order to participate in this study, all subjects must not meet any of the exclusion criteria described below: 1. Bedridden subjects (i.e. confined to bed by sickness or old age). 2. Subjects that are incapacitated and because of that in need of a Legally Authorized Representative. 3. Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study. 4. 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. 5. Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis. 6. Clinical conditions representing a contra-indication to intramuscular administration of vaccines or blood draw. 7. Abnormal function of the immune system resulting from: 1. Clinical conditions; 2. 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; 3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. 8. Receipt of immunoglobulins or any blood products within 180 days prior to informed consent. 9. 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. 10. Acute (severe) febrile illness. 11. 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. 12. Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.

Contacts and Locations

Sponsors and CollaboratorsSeqirus
Locations
84046-Accel Research Sites - Birmingham | Birmingham Alabama, United States, 3521684075-Cullman Clinical Trials | Cullman Alabama, United States, 3505584112-DM Clinical Research - Phoenix | Phoenix Arizona, United States, 8501284114-Scottsdale Clinical Trials | Scottsdale Arizona, United States, 8526084045-Lynn Institute of the Ozarks | Little Rock Arkansas, United States, 7220484070-Baptist Health Center for Clinical Research | Little Rock Arkansas, United States, 7220584101-West Coast Research LLC | Dublin California, United States, 9456884124-Leading Edge Research | Encino California, United States, 9131684104-Zillan Clinical Research | Inglewood California, United States, 9030384105-Eximia Research - CA | La Mesa California, United States, 9194284107-Long Beach Research Institute | Long Beach California, United States, 9080584109-Long Beach Clinical Trials | Long Beach California, United States, 9080684115-Central Valley Research | Modesto California, United States, 9535084120-Paradigm Research | Redding California, United States, 9600184119-Apex Clinical Research | San Diego California, United States, 9212084125-Lynn Institute of Denver | Aurora Colorado, United States, 8001284110-Tekton Research | Longmont Colorado, United States, 8050184123-Paradigm Research | Wheat Ridge Colorado, United States, 8003384085-Clinical Research Consulting, LLC | Milford Connecticut, United States, 0646084017-Chase Medical Research, LLC | Waterbury Connecticut, United States, 0670884029-Imagine Research of Palm Beach County | Boynton Beach Florida, United States, 3343584067-Innovative Research of West Florida, Inc. | Clearwater Florida, United States, 3375684006-Nature Coast Clinical Research - Crystal River | Crystal River Florida, United States, 3442984012-Evolution Clinical Trials | Doral Florida, United States, 3312284016-USA and International Research Inc. | Doral Florida, United States, 3312684061-Velocity Clinical Research - New Smyrna Beach | Edgewater Florida, United States, 3213284065-Fleming Island Center for Clinical Research | Fleming Island Florida, United States, 3200384027-SIMEDHealth, LLC | Gainesville Florida, United States, 3260784019-Green Leaf Clinical Trials | Jacksonville Florida, United States, 3225884026-Health Awareness, Inc. | Jupiter Florida, United States, 3345884071-3SYNC Research | Lake Worth Florida, United States, 3346084083-Accel Research Sites Network - St. Petersburg-Largo | Largo Florida, United States, 3377784082-Global Health Research Center, Inc. | Miami Lakes Florida, United States, 3301684081-Suncoast Research Associates, LLC | Pembroke Pines Florida, United States, 3302484024-St. Johns Center for Clinical Research | Saint Augustine Florida, United States, 3208684051-Precision Clinical Research | Sunrise Florida, United States, 3335184008-Global Health Research Center, Inc. - Tampa | Tampa Florida, United States, 3361584037-Eximia Research - GA | Atlanta Georgia, United States, 3031584086-Agile Clinical Research Trials, LLC | Atlanta Georgia, United States, 30328-612484054-Centricity Research Columbus | Columbus Georgia, United States, 3190484013-M3 Wake Research/Mount Vernon Clinical Research, LLC | Sandy Springs Georgia, United States, 3010384069-Velocity Clinical Research - Savannah | Savannah Georgia, United States, 3140684039-North Georgia Clinical Research | Woodstock Georgia, United States, 3018984118-Velocity Clinical Research - Boise | Meridian Idaho, United States, 8364284060-Great Lakes Clinical Trials LLC, dba Flourish Research | Chicago Illinois, United States, 6064084022-DM Clinical Research - River Forest | Melrose Park Illinois, United States, 6016084025-Velocity Clinical Research - Valparaiso | Valparaiso Indiana, United States, 4638384042-Velocity Clinical Research - Sioux City | Sioux City Iowa, United States, 5110684055-Velocity Clinical Research - Baton Rouge | Baton Rouge Louisiana, United States, 7080984088-Velocity Clinical Research - Covington | Covington Louisiana, United States, 7043384052-Velocity Clinical Research - Lafayette | Lafayette Louisiana, United States, 7050884064-Benchmark Research | Metairie Louisiana, United States, 7000684005-DM Clinical Research - Brookline | Brookline Massachusetts, United States, 0244684002-ActivMed Practices and Research, LLC | Methuen Massachusetts, United States, 0184484044-Clarkston Medical Group | Clarkston Michigan, United States, 4834684018-Quest Research Institute | Farmington Hills Michigan, United States, 4833484032-Bioscope Clinical Research, LLC | Farmington Hills Michigan, United States, 4833684001-Revival Research Institute, LLC | Southfield Michigan, United States, 4807584074-DM Clinical Research - Southfield | Southfield Michigan, United States, 4807684023-Velocity Clinical Research - Gulfport | Gulfport Mississippi, United States, 3950384038-Kansas City Research Institute | Kansas City Missouri, United States, 6413184057-Sundance Clinical Research | St Louis Missouri, United States, 6314184108-Boeson Research MSO | Missoula Montana, United States, 5980484030-Velocity Clinical Research - Grand Island | Grand Island Nebraska, United States, 6880384040-Velocity Clinical Research - Norfolk | Norfolk Nebraska, United States, 6870184007-Velocity Clinical Research - Omaha | Omaha Nebraska, United States, 6813484117-M3 Wake Research/CRCN | Las Vegas Nevada, United States, 8910684103-Alliance for Multispecialty Research, LLC | Las Vegas Nevada, United States, 8911984111-Vector Clinical Trials | Las Vegas Nevada, United States, 8912884106-Las Vegas Clinical Trials | North Las Vegas Nevada, United States, 8903084003-DM Clinical Research - New Jersey | Jersey City New Jersey, United States, 0730684122-Albuquerque Clinical Trials | Albuquerque New Mexico, United States, 8710284048-Velocity Clinical Research - Binghamton | Binghamton New York, United States, 1390584077-Velocity Clinical Research - Syracuse | East Syracuse New York, United States, 1305784014-Asheville Clinical Research | Asheville North Carolina, United States, 2880384089-Velocity Clinical Research - Durham | Durham North Carolina, United States, 2770184035-Monroe Biomedical Research | Monroe North Carolina, United States, 2811284102-Eximia Research - NC | Raleigh North Carolina, United States, 2760784020-M3 Wake Research/Raleigh Clinical Research, LLC | Raleigh North Carolina, United States, 2761284004-TMA Headlands LLC, dba Trial Management Associates | Wilmington North Carolina, United States, 2840384079-Progressive Medicine of the Triad, LLC | Winston-Salem North Carolina, United States, 2710384021-Velocity Clinical Research - Cleveland | Beachwood Ohio, United States, 4412284034-CTI Clinical Research Center | Cincinnati Ohio, United States, 4521284063-Velocity Clinical Research - Cincinnati (Mt. Auburn) | Cincinnati Ohio, United States, 4521984078-Tekton Research | Yukon Oklahoma, United States, 7309984121-Velocity Clinical Research - Medford | Medford Oregon, United States, 9750484050-3SYNC Research | Pittsburgh Pennsylvania, United States, 1524184009-Velocity Clinical Research - Providence | East Greenwich Rhode Island, United States, 0281884010-M3 Wake Research/Charleston Clinical Trials, LLC | Charleston South Carolina, United States, 2941484043-Velocity Clinical Research - Gaffney | Gaffney South Carolina, United States, 2934084056-Coastal Carolina Research Center, LLC | North Charleston South Carolina, United States, 2940584047-Velocity Clinical Research - Spartanburg | Spartanburg South Carolina, United States, 2930384053-Velocity Clinical Research - Union | Union South Carolina, United States, 2937984068-WR-ClinSearch, LLC | Chattanooga Tennessee, United States, 3742184090-Alliance for Multispecialty Research, LLC | Knoxville Tennessee, United States, 3790984084-Clinical Research Associates, Inc. | Nashville Tennessee, United States, 3720384072-WR-Global Medical Research, LLC | Dallas Texas, United States, 7522484028-Benchmark Research | Fort Worth Texas, United States, 7613584015-Trio Clinical Trials LLC | Houston Texas, United States, 7700884062-Activian Clinical Research | Kingwood Texas, United States, 7733984080-ACRC Trials | Plano Texas, United States, 7502484031-North Texas Family Medicine | Plano Texas, United States, 7509384066-Research Your Health | Plano Texas, United States, 7509384011-Clinical Trials of Texas, LLC, dba Flourish Research | San Antonio Texas, United States, 7822984076-DM Clinical Research - San Antonio | San Antonio Texas, United States, 7825784059-DM Clinical Research - Sugar Land | Sugar Land Texas, United States, 7747884087-DM Clinical Research - Tomball | Tomball Texas, United States, 7737584049-Charlottesville Medical Research | Charlottesville Virginia, United States, 2291184058-Clinical Research Partners | Richmond Virginia, United States, 2322684036-Velocity Clinical Research - Suffolk | Suffolk Virginia, United States, 2343584113-DM Clinical Research - Seattle | Seattle Washington, United States, 9812203603-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 , Turkey (Türkiye), 4138079211-Karadeniz Technical University Faculty of Medicine | Trabzon , Turkey (Türkiye), 71601-Charles River Medical Group, Mutala Trust and Infectious Disease Research Laboratory | Harare , Zimbabwe,
Investigators
Study Director: Clinical Program Director, Seqirus