A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age
A Phase 3, Randomized, Observer-blind, Active-controlled, Case-driven Study to Investigate the Safety, Efficacy, and Immunogenicity of mRNA-1010 Candidate Seasonal Influenza Vaccine Compared With a Licensed Inactivated Seasonal Influenza Vaccine in Adults ≥50 Years of Age
2 other identifiers
interventional
40,817
11 countries
301
Brief Summary
The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1010, and to evaluate relative vaccine efficacy (rVE) of mRNA-1010 versus an active comparator against reverse transcription polymerase chain reaction (RT-PCR)-confirmed protocol-defined influenza-like illness (ILI) caused by any influenza A or B strains.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2024
Shorter than P25 for phase_3
301 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 15, 2024
CompletedStudy Start
First participant enrolled
September 16, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2025
CompletedSeptember 10, 2025
September 1, 2025
11 months
September 15, 2024
September 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Day 1 to Day 7
Number of Participants with Unsolicited Adverse Events (AEs)
Day 1 to Day 28
Number of Participants with Medically Attended AEs (MAAEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), or Adverse Events of Special Interest (AESI)
Day 1 to Day 181
Time to First Episode of RT-PCR Confirmed Protocol Defined ILI
ILI caused by any influenza A or B strains.
Day 14 up to End of Season (up to approximately Day 181)
Secondary Outcomes (8)
Number of Participants with First Episode of RT-PCR Confirmed Modified US Centers for Disease Control and Prevention (CDC)-Defined ILI
Day 14 up to End of Season (up to approximately Day 181)
Number of Participants with First Episode of RT-PCR Confirmed Protocol-Defined ILI or Modified CDC-Defined ILI
Day 14 up to End of Season (up to approximately Day 181)
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI)
Day 29
Number of Participants Reaching Seroconversion as Measured by HAI
Day 29
Number of Participants with an HAI Titer ≥1:40
Day 29
- +3 more secondary outcomes
Study Arms (2)
mRNA-1010
EXPERIMENTALParticipants will receive a single injection of mRNA-1010 on Day 1.
Fluarix®, Fluarix Tetra, Influsplit® Tetra, Alpharix® Tetra
ACTIVE COMPARATORParticipants will receive a single injection of active comparator trivalent influenza vaccine (TIV) or quadrivalent influenza vaccine (QIV) (Fluarix®, Fluarix Tetra, Influsplit® Tetra, Alpharix® Tetra) on Day 1.
Interventions
Eligibility Criteria
You may qualify if:
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- Participants who are assigned female at birth or can become pregnant are eligible to participate if:
- The participant is a person of nonchildbearing potential (PONCBP) or
- The participant is a person of childbearing potential (POCBP) who:
- Is not breast/chest feeding.
- Is using an acceptable contraceptive method at least 28 days prior to Day 1 (Baseline) to at least 90 days after Day 1 (Baseline).
- Has a negative highly sensitive pregnancy test (urine or serum as required by local regulation or institutional review board \[IRB\]/independent ethics committee \[IEC\]) at the Screening Visit and before study intervention (if the Day 1 \[Baseline\] Visit is not on the same day as the Screening Visit).
You may not qualify if:
- Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) \[100.4° Fahrenheit \[F\]\]) within 72 hours prior to Day 1 (Baseline).
- Close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®/oseltamivir) within 5 days prior to Day 1 (Baseline).
- History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
- Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections disease.
- Tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1 (Baseline).
- History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any of the following: mRNA vaccine or therapeutic; components of an mRNA vaccine or therapeutic; influenza vaccine; or components of an influenza vaccine, including egg protein.
- Malignancy within 2 years prior to Day 1 (Baseline) (adequately treated basal cell carcinoma and squamous cell carcinoma are allowed).
- Received corticosteroids at ≥10 milligram (mg)/day of prednisone or equivalent for \>14 days in total within 90 days prior to Day 1 (Baseline) or is anticipating the need for corticosteroids at any time during the study.
- Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (for example, infliximab), within 180 days prior to Day 1 (Baseline) or plans to do so during the study.
- Treated with antiviral therapies for influenza (for example, Tamiflu) within 180 days prior to Day 1 (Baseline).
- Received any vaccine authorized or approved by local health agency within 28 days prior to Day 1 (Baseline) or plans to do so within 14 days after Day 1 (Baseline).
- Received a licensed seasonal influenza vaccine within 180 days prior to Day 1 (Baseline) or plans to do so (outside of this study) at any time during the study.
- Received an investigational seasonal influenza vaccine within 1 year prior to Day 1 (Baseline). Note: participants from mRNA-1010-P304 Season 1 are NOT eligible to re enroll into Season 2.
- Participated in a clinical study with investigational treatment within 90 days prior to Day 1 (Baseline) based on the medical history interview or plans to do so while participating in this study.
- Is working or has worked as study personnel or is an immediate family member or house member of study personnel, study staff, or Sponsor personnel.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ModernaTX, Inc.lead
Study Sites (301)
Pinnacle Research Group, Llc
Anniston, Alabama, 36207, United States
North Alabama Research Center, LLC
Athens, Alabama, 35611, United States
Flourish Research
Birmingham, Alabama, 35209, United States
EmVenio Research Brimingham, AL
Birmingham, Alabama, 35210, United States
Cullman Clinical Trials
Cullman, Alabama, 35055, United States
Optimal Research
Huntsville, Alabama, 35802, United States
Velocity Clinical Research
Mobile, Alabama, 36608, United States
Lenzmeier Family Medicine
Glendale, Arizona, 85308, United States
DM Clinical Research
Phoenix, Arizona, 85012, United States
Helios Clinical Research
Phoenix, Arizona, 85028, United States
Fiel Family and Sports Medicine
Tempe, Arizona, 85283, United States
Arizona Liver Health
Tucson, Arizona, 85711, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205, United States
Woodland Research
Rogers, Arkansas, 72758, United States
Benchmark Research - Colton
Colton, California, 92324, United States
Flourish Research
Covina, California, 91723, United States
Velocity Clinical Research - Huntington Park
Huntington Park, California, 90255, United States
Velocity Clinical Research, San Diego
La Mesa, California, 91942, United States
Long Beach Research Institute LLC
Long Beach, California, 90805, United States
Velocity Clinical Research - Westlake
Los Angeles, California, 90057, United States
M3 Wake Research/PRI, LLC
Newport Beach, California, 92660, United States
Carbon Health North Hollywood
North Hollywood, California, 91606, United States
Valley Clinical Trials, Inc.
Northridge, California, 91325, United States
Paradigm Research
Redding, California, 96001, United States
Artemis Institute for Clinical Research
Riverside, California, 92503, United States
Peninsula Research Associates (PRA)
Rolling Hills Estates, California, 90274, United States
Velocity Clinical Research - Banning
San Bernardino, California, 92408, United States
Artemis Institute for Clinical Research - Research Site
San Diego, California, 92103, United States
WHCR- M3 Wake Research
San Diego, California, 92111, United States
Wr-McCr, Llc
San Diego, California, 92120, United States
Velocity Clinical Research
Santa Ana, California, 92704, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Tekton Research - Fort Collins
Fort Collins, Colorado, 80525, United States
Tekton Research, Inc - Longmont Center
Longmont, Colorado, 80501, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
JEM Research Institue
Atlantis, Florida, 33462, United States
Nature Coast Clinical Research, LLC - Crystal River
Crystal River, Florida, 34429, United States
Homestead Associates in Research,Inc
Hialeah, Florida, 33016, United States
CenExel RCA
Hollywood, Florida, 33024, United States
Nature Coast Clinical Research, LLC - Inverness
Inverness, Florida, 34452, United States
Westside Center for Clinical Research
Jacksonville, Florida, 32205-4785, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Health Awareness INC
Jupiter, Florida, 33458, United States
M3 Wake Research/MSRA,LLC
Lake City, Florida, 32055, United States
Accel Clinical Research
Lake Mary, Florida, 32746, United States
Clinical Site Partners - Leesburg
Leesburg, Florida, 34748, United States
ARS - Meridien Research
Maitland, Florida, 32751, United States
K2 medical research
Maitland, Florida, 32751, United States
South Florida Research Center, Inc.
Miami, Florida, 33135, United States
Miami Clinical Research
Miami, Florida, 33155, United States
Suncoast Research Associates, LLC
Miami, Florida, 33173, United States
Floridian Clinical Research
Miami Lakes, Florida, 33016, United States
Headlands Research
Orlando, Florida, 32819, United States
Suncoast Research Associates
Pembroke Pines, Florida, 33024, United States
Health Awareness INC
Port Saint Lucie, Florida, 34952, United States
IMA Clinical Research Warren
St. Petersburg, Florida, 33704, United States
Forward Clinical Trials - Dermatology
Tampa, Florida, 33613, United States
Clinical Site Partners, LLC
Winter Park, Florida, 32789, United States
JAVARA
Albany, Georgia, 31707, United States
IACT Health
Columbus, Georgia, 31904, United States
CenExel iResearch , LLC
Decatur, Georgia, 30030, United States
CenExel iResearch Savannah
Savannah, Georgia, 31405, United States
Velocity Clinical Research-Savannah
Savannah, Georgia, 31406-2675, United States
Javara - Privia Medical Group Georgia, LLC
Savannah, Georgia, 31406, United States
Clinical Research Atlanta/Headlands
Stockbridge, Georgia, 30281, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814-4526, United States
Bingham Memorial Hospital
Blackfoot, Idaho, 83221, United States
Velocity Clinical Research - Boise
Meridian, Idaho, 83642, United States
EmVenio Research
Chicago, Illinois, 60608, United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
DM Clinical Research- River Forest
Melrose Park, Illinois, 60160, United States
Velocity Clinical Research - Valparaiso
Valparaiso, Indiana, 46383, United States
Velocity Clinical Research-Sioux City
Sioux City, Iowa, 51106, United States
Alliance for Multispecialty Research
Augusta, Kansas, 67010, United States
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas, 66219-1376, United States
DelRicht Research - Overland Park
Overland Park, Kansas, 66209, United States
AMR
Wichita, Kansas, 67207, United States
Velocity Clinical Research - Baton Rouge
Baton Rouge, Louisiana, 70809, United States
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, 70508, United States
IMA Clinical Research Monroe
Monroe, Louisiana, 71201, United States
DelRicht Research
New Orleans, Louisiana, 70115, United States
Velocity Clinical Research
New Orleans, Louisiana, 70119, United States
DelRicht Research @ Neighborhood Health
Prairieville, Louisiana, 70769-4212, United States
Privia Medical Group
Annapolis, Maryland, 21401, United States
Cenexel CBH (CBH Health)
Gaithersburg, Maryland, 20877, United States
Matthew Mintz Clinic
Rockville, Maryland, 20852, United States
Velocity Clinical Research - Covington
Rockville, Maryland, 20854, United States
DM Clinical Research - Brookline
Brookline, Massachusetts, 02446, United States
Headlands Research - Detroit
Southfield, Michigan, 48034, United States
Great Lakes Research Institute
Southfield, Michigan, 48075-5400, United States
DM Clinical Research
Southfield, Michigan, 48076, United States
DELRICHT RESEARCH at GULFPORT MEMORIAL
Gulfport, Mississippi, 39503, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
Clinvest
Springfield, Missouri, 65807, United States
Delricht Research
Springfield, Missouri, 65807, United States
Sundance Clinical Research, LLC
St Louis, Missouri, 63141, United States
Delricht
Town and Country, Missouri, 63017, United States
Boeson Research MSO
Missoula, Montana, 59804, United States
Elias Research Associates
Missoula, Montana, 59808, United States
Velocity Clinical Research-Grand Island
Grand Island, Nebraska, 68803, United States
Platinum Research Network, LLC
Lincoln, Nebraska, 68510, United States
Velocity Clinical Research-Norfolk
Norfolk, Nebraska, 68701, United States
Velocity Clinical Research-Omaha
Omaha, Nebraska, 68134, United States
Henderson Clinical Trials
Henderson, Nevada, 89052, United States
M3 Wake Research/CRCN, LLC
Las Vegas, Nevada, 89106, United States
Office of Michael B. Jacobs, MD
Las Vegas, Nevada, 89119, United States
DM Clinical Research - New Jersey
Jersey City, New Jersey, 07306, United States
IMA Clinical Research Warren
Warren Township, New Jersey, 07059, United States
DM Clinical Research-Albuquerque
Albuquerque, New Mexico, 87106, United States
AXCES Research Group - Sante Fe
Albuquerque, New Mexico, 87109, United States
Velocity Clinical Research - Binghamton
Binghamton, New York, 13905, United States
DM Clinical
Brooklyn, New York, 11220, United States
RCR Buffalo
Buffalo, New York, 14217, United States
Velocity Clinical Research, Syracuse
East Syracuse, New York, 13057, United States
IMA Clinical Research
Hartsdale, New York, 10530, United States
IMA Research
New York, New York, 10036, United States
Rochester Clinical Research, Inc
Rochester, New York, 14609, United States
Velocity Clinical Research-Vestal
Vestal, New York, 13850, United States
Asheville Clinical Research
Asheville, North Carolina, 28803, United States
DelRicht Research, LLC
Charlotte, North Carolina, 28205, United States
Lucas Research
Morehead City, North Carolina, 23730, United States
Eximia Clinical Research
Raleigh, North Carolina, 27607, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612, United States
Accellacare US Inc.
Salisbury, North Carolina, 28144, United States
Accellacare Research Wilmington
Wilmington, North Carolina, 28401, United States
Trial Management Associates, LLC
Wilmington, North Carolina, 28403, United States
Javara - Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Community Research
Cincinnati, Ohio, 45212, United States
Velocity Clinical Research-Mt. Auburn
Cincinnati, Ohio, 45219, United States
Velocity Clinical Research - Cincinnati
Cincinnati, Ohio, 45242, United States
Centricity Research Columbus
Columbus, Ohio, 43213, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Tekton Research, Inc - Edmond
Edmond, Oklahoma, 73013, United States
Delricht Tate
Tulsa, Oklahoma, 74133, United States
Tekton Research, Inc - Yukon Location
Yukon, Oklahoma, 73099, United States
The Corvallis Clinic
Corvallis, Oregon, 97330, United States
Summit Research
Portland, Oregon, 97210, United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, 19107, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401, United States
Velocity Clinical Research - Providence
Providence, Rhode Island, 02886, United States
Velocity Clinical Research - Anderson
Anderson, South Carolina, 29621, United States
DelRicht Research
Charleston, South Carolina, 29407, United States
Charleston Clinical Trials, LLC
Charleston, South Carolina, 29414, United States
Velocity Clinical Research, Spartanburg
Columbia, South Carolina, 29204, United States
Velocity Clinical Research, Gaffney
Gaffney, South Carolina, 29340, United States
Carolina Health Specialists
Myrtle Beach, South Carolina, 29572, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
Velocity Clinical Research- UNION
Union, South Carolina, 29379, United States
Black Hills Center for American Indian Health
Rapid City, South Dakota, 57701, United States
M3 Wake Research/ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Helios Clinical Research
Jackson, Tennessee, 38305, United States
MultiSpeciality Clinical Research
Johnson City, Tennessee, 37601, United States
Avant Reseach Associates
Austin, Texas, 78745, United States
Tekton Research, Inc
Austin, Texas, 78745, United States
Tekton Research, LLC
Beaumont, Texas, 78705, United States
Headlands Research Brownsville
Brownsville, Texas, 78526, United States
3A Research, LLC
El Paso, Texas, 79225, United States
Helios
Fort Worth, Texas, 76104, United States
Benchmark Research
Fort Worth, Texas, 76135, United States
Helios Clinical Research
Houston, Texas, 77008-1374, United States
DM Clinical Research - CyFair
Houston, Texas, 77065, United States
DM Clinical Research- Bellaire
Houston, Texas, 77081, United States
Helios CR, Inc. Keller Tx
Keller, Texas, 76248, United States
Research Your Health
Plano, Texas, 75093, United States
DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE
Prosper, Texas, 75078, United States
DM Clinical Research
San Antonio, Texas, 78207, United States
IMA Clinical Research
San Antonio, Texas, 78229, United States
Tekton Research Inc - San Antonio
San Antonio, Texas, 78229, United States
San Marcos Family Medicine
San Marcos, Texas, 78666, United States
Stephenville Medical & Surgical Clinic, PA
Stephenville, Texas, 76401, United States
Breco Research - A Tarheel Clinical Research Site
Sugar Land, Texas, 77478, United States
DM Clinical Research - Sugarland
Sugar Land, Texas, 77478, United States
DM Clinical Research - Tomball
Tomball, Texas, 77375, United States
DM Clinical Research
Tomball, Texas, 77375, United States
Synexus Clinical Research US, Inc.
Salt Lake City, Utah, 84106, United States
CenExel - JBR
Salt Lake City, Utah, 84107, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc.
Salt Lake City, Utah, 84121, United States
J. Lewis Research, Inc/Jordan River Family Medicine
South Jordan, Utah, 84095, United States
Javara
Alexandria, Virginia, 22311, United States
Velocity Clinical Research-Hampton
Hampton, Virginia, 23666-5843, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606-4537, United States
Velocity Clinical Research-Portsmouth
Portsmouth, Virginia, 23702, United States
Clinical Research Partners, LLC
Richmond, Virginia, 23226, United States
Amherst Family Practice
Winchester, Virginia, 22601, United States
Velocity Clinical Research- Spokane
Spokane, Washington, 99218, United States
Confluence Health
Wenatchee, Washington, 98801, United States
Anima Research Center
Alken, 3570, Belgium
Universitair Ziekenhuis Gent
Ghent, 10 - 9000, Belgium
AZ Sint Maarten
Mechelen, 435 2800, Belgium
University of Antwerpen - Vaccinopolis
Wilrijk, 663 2650, Belgium
Medical center "Dr. Staykov" Ltd.
Burgas, Bulgaria
MHAT "Sveti Ivan Rilski"
Kozloduy, Bulgaria
Medical Center Medconsult Pleven, Lovech branch
Lovech, Bulgaria
Medical Center Hera - Montana branch
Montana, Bulgaria
MHAT "Dr. Stamen Iliev"
Montana, Bulgaria
Medical Center Medconsult Pleven
Pleven, Bulgaria
AIPPMP Dr. Levena Kireva
Plovdiv, Bulgaria
MHAT "Sv. Panteleymon" Ltd.
Plovdiv, Bulgaria
DCC-1 Sliven Lts.
Sliven, Bulgaria
MHAT Sliven to MMA Sofia
Sliven, Bulgaria
Diagnostic & Consultancy Center Ascendent, Sofia
Sofia, Bulgaria
Medical Center "Hera" EOOD
Sofia, Bulgaria
Medical Center Excelsior - Base 2
Sofia, Bulgaria
Medical Center Excelsior OOD, Base1
Sofia, Bulgaria
Medical Centre "Sirtuin" Ltd
Sofia, Bulgaria
AIPPMP D-r Zhaneta Demireva Ltd.
Stamboliyski, Bulgaria
Aviva Medical Diagnostics and Specialists Clinic and Heart & Vascular Centre
Burlington, Canada
CARe Clinic, Calgary, AB
Calgary, Canada
Centricity Research Quebec City
Lévis, Canada
Milestone Research Inc.
London, Canada
Red Maple Trials
Ottawa, Canada
Centricity Research Pointe-Claire
Pointe-Claire, Canada
Clinique de Lebourgneuf
Québec, Canada
CARe , Red Deer, AB.
Red Deer, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Canada
Stouffville Medical Research Institute
Stouffville, Canada
Canadian Phase Onward Inc.
Toronto, Canada
Centricity Research Toronto LMC
Toronto, Canada
Diex Recherche
Trois-Rivières, Canada
Colchester Research Group
Truro, Canada
Diex Recherche Victoriaville
Victoriaville, Canada
Vee Family Doctors' Center
Paide, 6, Estonia
Center of Clinical and Basic Research
Tallinn, 4, Estonia
Merelahe Family Doctors Centre
Tallinn, 68A, Estonia
Innomedica OU
Tallinn, 7, Estonia
Clinical Research Center
Tartu, 54, Estonia
FVR - Finnish Vaccine Research Ltd - Espoo
Espoo, Finland
FVR - Finnish Vaccine Research Ltd - Kokkola
Kokkola, Finland
FVR - Finnish Vaccine Research Ltd - Oulu
Oulu, Finland
FVR - Finnish Vaccine Research Ltd - Tampere
Tampere, Finland
FVR - Finnish Vaccine Research Ltd - Järvenpää
Turku, Finland
Unimed Adjara Ltd - Batumi Referral Hospital
Batumi, Georgia
LTD "Hospital service"
Kutaisi, Georgia
LTD Clinic Rustavi
Rustavi, Georgia
Emergency Cardiology Center named by acad. G. Chapidze
Tbilisi, Georgia
Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, Georgia
LTD Israel-Georgian Medical Research Clinic Helsicore
Tbilisi, Georgia
Emovis GmbH
Berlin, Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin, Germany
Velocity Clinical Research Berlin, GmbH
Berlin, Germany
Praxis Rinke
Bochum, Germany
Klinische Forschung Dresden GmbH
Dresden, Germany
Medizentrum Essen Borbeck
Essen, Germany
IKF Pneumologie
Frankfurt, Germany
Infektio Research GmbH & Co.KG
Frankfurt, Germany
Klinische Forschung Hamburg GmbH
Hamburg, Germany
Velocity Clincial Research Hamburg GmbH
Hamburg, Germany
Klinische Forschung Hannover Mitte GmbH
Hanover, Germany
Klinische Forschung Karlsruhe
Karlsruhe, Germany
SMO.MD
Magdeburg, Germany
Dermatologie Quist BAG Dres. Med. Quist Part G
Mainz, Germany
CDG Studienambulanz
München, Germany
Future meds Offenbach
Offenbach, Germany
Red-Institut
Oldenburg, Germany
Klinische Forschung Schwerin GmbH
Schwerin, Germany
Studienzentrum Brinkum
Stuhr, Germany
Hautarztpraxis Leitz & Kollegen
Stuttgart, Germany
Velocity Clinical Research Wiesbaden
Wiesbaden, Germany
Korea University Ansan Hospital
Ansan-si, South Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Inha University Hospital
Incheon, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Yonsei University, Wonju Severance Christian Hospital
Wŏnju, South Korea
Kaohsiung Veterans General Hospital
Kaohsuing City, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
Taoyuan, Taiwan
Panthera Biopartners site - York
Acomb, York, United Kingdom
FutureMeds Birmingham
Birmingham, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Layton Medical Centre
Blackpool, United Kingdom
Lakeside Healthcare
Corby, United Kingdom
NHS Lothian - Western General Hospital
Edinburgh, United Kingdom
Panthera Biopartners site - Enfield
Enfield, United Kingdom
Royal Devon University Healthcare NHS Foundation Trust
Exeter, United Kingdom
FutureMeds - Glasgow
Glasgow, United Kingdom
Glasgow Panthera Biopartners Site
Glasgow, United Kingdom
Barts Health NHS Trust - Mile End Hospital
London, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, United Kingdom
Guy's and St Thomas's NHS Foundation Trust
London, United Kingdom
HMC Research Group
London, United Kingdom
St George's University Hospitals (NHS Foundation Trust)
London, United Kingdom
Velocity Clinical Research - North London
London, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
FutureMeds Wirral
Metropolitan Borough of Wirral, United Kingdom
Infectious Diseases Research - Clinical Research Facility
Newcastle upon Tyne, United Kingdom
Norfolk nand Norwich University Hospital
Norwich, United Kingdom
University of Nottingham Health Service
Nottingham, United Kingdom
Wansford Research Limited
Peterborough, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom
Portsmouth Hospitals University NHS Trust - Portsmouth Research Hub
Portsmouth, United Kingdom
Panthera Biopartners - Manchester
Rochdale, United Kingdom
Sheffield Panthera Biopartners Site
Sheffield, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Future Meds - Teesside
Stockton-on-Tees, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2024
First Posted
September 19, 2024
Study Start
September 16, 2024
Primary Completion
August 21, 2025
Study Completion
August 21, 2025
Last Updated
September 10, 2025
Record last verified: 2025-09