A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis
Nova 301
A Phase 3, Randomized, Observer-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of mRNA-1403, a Multivalent Candidate Vaccine to Prevent Norovirus Acute Gastroenteritis in Adults ≥18 Years of Age
1 other identifier
interventional
37,864
7 countries
283
Brief Summary
The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1403, and to demonstrate the efficacy of mRNA-1403 to prevent protocol-defined moderate or severe norovirus acute gastroenteritis (AGE) associated with vaccine matched genotypes.
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
283 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 9, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
September 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 15, 2027
February 25, 2026
February 1, 2026
2.4 years
September 9, 2024
February 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Day 1 up to Day 7 (7 days after study intervention)
Number of Participants with Unsolicited Adverse Events (AEs)
Day 1 up to Day 28 (28 days after study intervention)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Day 1 through Day 181
Number of Participants with Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal
Day 1 up to Day 546 (Cohort 1) and Day 365 (Cohorts 2 and 3)
Vaccine Efficacy (VE) of mRNA-1403 to Prevent First Occurrence of Protocol-defined Moderate or Severe AGE Associated with Vaccine Matched Genotypes
Day 15 up to 6 months after the last participant dosed in each cohort
Secondary Outcomes (14)
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Severe AGE Associated with Vaccine Matched Genotypes
Day 15 up to 6 months after the last participant dosed in each cohort
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Severe Norovirus (NoV) AGE Associated with Any Genogroup I or II Norovirus (NoV) Genotype
Day 15 up to 6 months after the last participant dosed in each cohort
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Moderate or Severe AGE Associated with Any Genogroup I or II NoV Genotype
Day 15 up to 6 months after the last participant dosed in each cohort
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined AGE of Any Severity Associated with Vaccine Matched NoV Genotypes
Day 15 up to 6 months after the last participant dosed in each cohort
VE of mRNA-1403 to Prevent Any Occurrence of Medically Attended AGE Associated with Vaccine Matched NoV Genotypes, as well as any Genogroup I or II NoV Genotype
Day 15 up to Day 546 (Cohort 1) and Day 365 (Cohorts 2 and 3)
- +9 more secondary outcomes
Study Arms (2)
mRNA-1403
EXPERIMENTALParticipants will receive a single injection of mRNA-1403 on Day 1.
Placebo
PLACEBO COMPARATORParticipants will receive a single injection of mRNA-1403 matching placebo (0.9% sodium chloride solution) on Day 1.
Interventions
Eligibility Criteria
You may qualify if:
- Participants who understand and are willing and physically able to comply with protocol mandated follow-up, including all procedures as assessed by the Investigator, and who are primarily responsible for their self-care and activities of daily living.
- Participants may have chronic medical diagnoses but should be medically stable as assessed by the following criteria:
- Absence of medical events associated with underlying diagnoses and qualifying as SAEs within 1 month prior to study intervention on Day 1.
- Absence of known, current, and life-limiting diagnoses, which could continue for the duration of the study and which, in the opinion of the Investigator, would make completion of the protocol unlikely.
- 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 assigned female at birth are eligible to participate if they are not pregnant or breastfeeding/chestfeeding/bodyfeeding and meet protocol defined criteria.
You may not qualify if:
- Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius (°C) \[100.4 degrees Fahrenheit \[°F\]) 72 hours prior to or at the Screening Visit or Day 1.
- History of AGE within 14 days prior to Day 1 or close contact with an individual with AGE symptoms (in the home, socially, or occupationally) within 14 days prior to Day 1.
- History of a diagnosis or condition that in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
- Current diagnosis of chronic gastrointestinal (GI) disease that is associated with ongoing symptoms of regular vomiting and/or diarrhea. Participants with stable, well-controlled chronic GI disease without regular vomiting and/or diarrhea can be considered for enrollment.
- Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the investigator's judgment.
- Has undergone surgical procedures within 7 days prior to Day 1 or is scheduled to undergo a surgical procedure within 28 days after study intervention.
- Reported history of congenital or acquired immunodeficiency, immunocompromising/immunosuppressive condition, asplenia, or recurrent severe infections per protocol.
- Reported history of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine or intervention that includes one or more of the same components contained in the study vaccine.
- History of myocarditis, pericarditis, or myopericarditis with onset within 180 days prior to Day 1 whose values have not returned to Baseline clinical status.
- History of Guillain-Barré syndrome.
- Reported history of coagulopathy or bleeding disorder considered a contraindication to IM injection or phlebotomy.
- Dermatologic conditions that could affect local solicited AR assessments.
- Diagnosis of malignancy within the previous 2 years (excluding nonmelanoma skin cancer).
- Has received systemic immunosuppressive therapies for \>14 days in total within 6 months prior to Day 1 (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
- Has received or plans to receive any licensed vaccine ≤28 days prior to or within 28 days after study intervention (Day 1), except for influenza vaccines, which may be given 14 days before or after receipt of a study intervention.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ModernaTX, Inc.lead
Study Sites (283)
Accel Research Sites - Achieve Clinical Research
Birmingham, Alabama, 32516, United States
Cullman Clinical Trials
Cullman, Alabama, 35055, United States
Alliance for Multispecialty Research, LLC
Daphne, Alabama, 36526, United States
ClinMed, LLC
Phoenix, Arizona, 85004, United States
DM Clinical - Phoenix
Phoenix, Arizona, 85012, United States
HOPE Research Institute
Phoenix, Arizona, 85018, United States
HOPE Research Institute
Phoenix, Arizona, 85023, United States
Abby's Research Institute
Phoenix, Arizona, 85031, United States
Headlands Research Scottsdale
Scottsdale, Arizona, 85260, United States
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260, United States
Hope Research Institute - Tempe
Tempe, Arizona, 85284, United States
Arizona Liver Health
Tucson, Arizona, 85712, United States
Quality of Life Medical and Research Center
Tucson, Arizona, 85712, United States
Del Sol Research Management LLC.- Tucson
Tucson, Arizona, 85715, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72204, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205, United States
ARK Clinical Research, LLC
Fountain Valley, California, 92708, United States
ASCADA Research, LLC - Family Medicine
Fullerton, California, 92835, United States
Matrix Clinical Research
Huntington Park, California, 90255, United States
Velocity Clinical Research, San Diego
La Mesa, California, 91942, United States
Ark Clinical Research
Long Beach, California, 90815, United States
Matrix Clinical Research
Los Angeles, California, 90057, United States
Velocity Clinical Research - Westlake
Los Angeles, California, 90057, United States
Paradigm Research
Redding, California, 96001, United States
Artemis Institute for Clinical Research
Riverside, California, 92503, United States
Benchmark Research
Riverside, California, 92503, United States
Peninsula Research Associates (PRA)
Rolling Hills Estates, California, 90274, United States
Apex Clinical Research
San Diego, California, 92120, United States
Artemis Institute for Clinical Research
San Diego, California, 92503, United States
Lynn Institute of Denver
Aurora, Colorado, 80012, United States
Tekton Research - Fort Collins
Fort Collins, Colorado, 80525, United States
Tekton Research, Inc - Longmont Center
Longmont, Colorado, 80501, United States
Imagine Research of Palm Beach County
Boynton Beach, Florida, 33435, United States
Pioneer Clinical Studies
Coral Gables, Florida, 33134, United States
Integrity Clinical Research, LLC (ICR SITES) - Doral
Doral, Florida, 33122, United States
Alliance for multispecialty Research - Florida
Doral, Florida, 33134, United States
AGA Clinical Trials
Hialeah, Florida, 33012, United States
Best Quality Research Inc.
Hialeah, Florida, 33016, United States
Neoclinical Research
Hialeah, Florida, 33016, United States
Research Centers of America
Hollywood, Florida, 33024, United States
Nature Coast Clinical Research, LLC - Inverness
Inverness, Florida, 34452, United States
Westside Center for Clinical Research
Jacksonville, Florida, 32216, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256, United States
Health Awareness INC
Jupiter, Florida, 33458, United States
University Clinical Research- Deland
Lake Mary, Florida, 32746, United States
Meridien Research
Lakeland, Florida, 33803, United States
Clinical Site Partners - Leesburg
Leesburg, Florida, 34748, United States
Accel Clinical Research - Maitland
Maitland, Florida, 32751, United States
Dade Research Center, LLC
Miami, Florida, 33126, United States
Miami Clinical Research
Miami, Florida, 33155, United States
Universal Axon Clinical Research
Miami, Florida, 33166, United States
Florida International Research Center
Miami, Florida, 33173, United States
Suncoast Research Associates, LLC
Miami, Florida, 33173, United States
Miami Dade Medical Research Institute, LLC
Miami, Florida, 33176, United States
Felicidad Medical Research
Miami, Florida, 33184, United States
Aqualane Clinical Research
Naples, Florida, 34105, United States
SUNCOAST Clinical Research
New Port Richey, Florida, 34652, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32806, United States
Clinical Research Center of Florida
Pompano Beach, Florida, 33060, United States
United Medical Research
Port Orange, Florida, 32127, United States
Health Awareness, Inc
Port Saint Lucie, Florida, 34952, United States
St. Johns Center for Clinical Research
Saint Augustine, Florida, 32086, United States
IMA Clinical Research - St. Petersburg
St. Petersburg, Florida, 33704, United States
Global Clinical Professionals, LLC
St. Petersburg, Florida, 33705, United States
Precision Clinical Research, LLC
Sunrise, Florida, 33351, United States
Albany Internal Medicine
Albany, Georgia, 31707, United States
Delricht Research At Springer Wellness And Restorative Health
Atlanta, Georgia, 30329, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
CenExel iResearch Atlanta, LLC
Decatur, Georgia, 30030, United States
Javara Inc.
Fayetteville, Georgia, 30214, United States
Fellows Research Alliance, Inc.
Savannah, Georgia, 31406, United States
Velocity Clinical Research-Savannah
Savannah, Georgia, 31406, United States
Clinical Research Atlanta/Headlands
Stockbridge, Georgia, 30281, United States
Clinical Research Prime
Idaho Falls, Idaho, 83404, United States
Velocity Clinical Research - Boise
Meridian, Idaho, 83642, United States
IMA Clinical Research
Chicago, Illinois, 60602, United States
Great Lakes Clinical Trials - Gurnee
Gurnee, Illinois, 60048, United States
Bioluminix Clinical Research Chicago
Naperville, Illinois, 60540, United States
Optimal Research
Peoria, Illinois, 61614, United States
DM Clinical Research- River Forest
River Forest, Illinois, 60305, United States
Velocity Clinical Research - Valparaiso
Valparaiso, Indiana, 46383, United States
Velocity Clinical Research-Sioux City
Sioux City, Iowa, 51106, United States
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas, 66219, United States
Velocity Clinical Research- Kansas City
Overland Park, Kansas, 66210, United States
Tekton Research
Wichita, Kansas, 67218, United States
AMR Lexington
Lexington, Kentucky, 40509, United States
Velocity Clinical Research - Baton Rouge
Baton Rouge, Louisiana, 70809, United States
Velocity Clinical Research - Covington
Covington, Louisiana, 70433, United States
Benchmark Research
Metairie, Louisiana, 70006, United States
Clinical Trials Management, LLC
Metairie, Louisiana, 70006, United States
Privia Medical Group
Annapolis, Maryland, 27101, United States
Cenexel CBH (CBH Health)
Gaithersburg, Maryland, 20877, United States
Velocity Clinical Research-Rockville
Rockville, Maryland, 20854, United States
Javara Inc/Privia Medical Group, LLC
Silver Spring, Maryland, 20901, United States
DM Clinical Research - Brookline
Brookline, Massachusetts, 02445, United States
Skylight Health Research - Burlington
Burlington, Massachusetts, 02721, United States
Headlands Research - Detroit
Southfield, Michigan, 48034, United States
Great Lakes Research Institute
Southfield, Michigan, 48075, United States
DM Clinical Research - Southfield
Southfield, Michigan, 48076, United States
Oakland Medical Research Center
Troy, Michigan, 48085, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402, United States
Velocity Clinical Research, Gulfport
Gulfport, Mississippi, 39503, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
Clinvest Headlands LLC
Springfield, Missouri, 65807, United States
Delricht Research
Springfield, Missouri, 65807, United States
Montana Medical Research, Inc
Missoula, Montana, 59808, United States
Velocity Clinical Research-Lincoln
Lincoln, Nebraska, 68510, United States
Velocity Clinical Research-Norfolk
Norfolk, Nebraska, 68701, United States
Velocity Clinical Research-Omaha
Omaha, Nebraska, 38134, United States
Javara Inc. / Nevada Health Centers, Ind
Carson City, Nevada, 89706, United States
Vector Clinical Trials
Las Vegas, Nevada, 89074, United States
Oasis Clinical Research
Las Vegas, Nevada, 89121, 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
Albuquerque Clinical Trials (ACT)
Albuquerque, New Mexico, 87102, United States
DM Clinical Research
Albuquerque, New Mexico, 87106, United States
Velocity Clinical Research- Albuquerque
Albuquerque, New Mexico, 87107, United States
Velocity Clinical Research - Binghamton
Binghamton, New York, 13905, United States
DM Clinical - Brooklyn
Brooklyn, New York, 11220, United States
Brooklyn Clinical Research
Brooklyn, New York, 11226, United States
Velocity Clinical Research - Syracuse
East Syracuse, New York, 13057, United States
Drug Trials America
Hartsdale, New York, 10530, United States
Rochester Clinical Research, Inc
Rochester, New York, 14609, United States
Velocity Clinical Research-Vestal
Vestal, New York, 13850, United States
DelRicht Research, LLC
Charlotte, North Carolina, 28205, United States
Javara Inc. - Tryon Medical-South Park
Charlotte, North Carolina, 28287, United States
Velocity Clinical Research, Durham
Durham, North Carolina, 27701, United States
West Clinical Research
Morehead City, North Carolina, 28557, United States
Accellacare Raleigh
Raleigh, North Carolina, 27609, United States
Accellacare of Wilmington
Wilmington, North Carolina, 28401, United States
Javara - Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27101, United States
Velocity Clinical Research, Cleveland
Beachwood, Ohio, 44122, United States
Velocity Clinical Research-Mt. Auburn
Cincinnati, Ohio, 45219, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45241, United States
Velocity Clinical Reseach - Blue Ash
Cincinnati, Ohio, 45242, United States
Velocity Clinical Research - Cincinnati OH
Cincinnati, Ohio, 45246, United States
Centricity Research
Columbus, Ohio, 43213, United States
Remington-Davis Clinical Research
Columbus, Ohio, 43215, 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
Altoona Center for Clinical Research - Research
Duncansville, Pennsylvania, 16635, United States
DM Clinical Research
Philadelphia, Pennsylvania, 19107, United States
Velocity Clinical Research - Providence
East Greenwich, Rhode Island, 02818, United States
Velocity Clinical Research - Anderson
Anderson, South Carolina, 29621, United States
DelRicht Research
Charleston, South Carolina, 29407, United States
Coastal Carolina Research Center - North Charleston
North Charleston, South Carolina, 29405, United States
Velocity Clinical Research, Spartanburg
Spartanburg, South Carolina, 29303, United States
PMG Research of Bristol, LLC
Bristol, Tennessee, 37620, United States
Delricht Moyer
Hendersonville, Tennessee, 37075, United States
CNS Healthcare DBA Clinical Neuroscience Solutions, INC
Memphis, Tennessee, 38119, United States
Benchmark Research
Austin, Texas, 78705, United States
IMA Clinical Research Austin
Austin, Texas, 78745, United States
Tekton Research, Inc. - Beaumont
Beaumont, Texas, 77706, United States
Headlands Research Brownsville
Brownsville, Texas, 78526, United States
Family Medicine Associates of Texas
Carrollton, Texas, 75010, United States
Javara Inc (Conroe)
Conroe, Texas, 77384, United States
WR-Global Medical Research, LLC
Dallas, Texas, 75224, United States
El Paso Research
El Paso, Texas, 79936, United States
Benchmark Research
Fort Worth, Texas, 76135, United States
West Houston Clinical Research Service
Houston, Texas, 77055, United States
DM Clinical Research - CyFair
Houston, Texas, 77065, United States
DM Clinical Research - Bellaire
Houston, Texas, 77081, United States
DM Clinical Research - Irving
Irving, Texas, 75061, United States
ACRC Trials
Plano, Texas, 75024, 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
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
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
Cope Family Medicine
Bountiful, Utah, 84010, United States
JBR Clinical Research
Salt Lake City, Utah, 84107, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911, United States
Velocity Clinical Research - Hampton
Hampton, Virginia, 23666, United States
Health Research of Hampton Roads
Newport News, Virginia, 23606, United States
AMR Norfolk
Norfolk, Virginia, 37920, United States
Velocity Clinical Research-Portsmouth
Portsmouth, Virginia, 23703, United States
Clinical Research Partners, LLC
Richmond, Virginia, 23226, United States
DM Clinical Research - Seattle
Seattle, Washington, 98122, United States
Frontier Clinical Research, LLC
Kingwood, West Virginia, 26537, United States
Paratus Clinical Research Canberra
Bruce, Australian Capital Territory, 2617, Australia
Northside Health
Coffs Harbour, New South Wales, 2450, Australia
Momentum Clinical Research Darlinghurst
Darlinghurst, New South Wales, 2010, Australia
Paratus Clinical Research Central Coast
Kanwal, New South Wales, 2259, Australia
Australian Clinical Research Network
Maroubra, New South Wales, 2035, Australia
Paratus Clinical Research Brisbane
Herston, Queensland, 4006, Australia
Griffith University Hospital
Southport, Queensland, 4222, Australia
Fusion Clinical Research
Norwood, South Australia, 5067, Australia
Veritus Research
Bayswater, Victoria, 3153, Australia
Emeritus Research (Melbourne)
Camberwell, Victoria, 3124, Australia
The Peter Doherty Institute for Infection & Immunity
North Melbourne, Victoria, 3051, Australia
CARe Clinic
Calgary, Canada
Intermed Groupe Sante
Chicoutimi, Canada
Medicor Research Inc.
Greater Sudbury, Canada
Apex Trials
Guelph, Canada
Isaak Walton Killam Health Centre
Halifax, Canada
Okanagan Clinical Trials
Kelowna, Canada
Centricity Research Quebec City
Lévis, Canada
Milestone Research Inc.
London, Canada
Centricity Research Mirabel
Mirabel, Canada
Centricity Research Pointe-Claire
Pointe-Claire, Canada
Centre de Recherche Saint-Louis
Québec, Canada
Clinique Spécialisée en Allergie de la Capitale
Québec, Canada
CARe Clinic Red Deer
Red Deer, Canada
Richmond Clinical Trials
Richmond, Canada
Bluewater Clinical Research Group, Inc
Sarnia, Canada
Diex Research Sherbrooke Inc
Sherbrooke, Canada
Centricity Research Toronto LMC
Toronto, Canada
Diex Recherche Trois-Rivières
Trois-Rivières, Canada
Colchester Research Group
Truro, Canada
Chubu Rosai Hospital - Rheumatology & Collageous
Nagoya, Aichi-ken, Japan
Daido clinic
Nagoya, Aichi-ken, Japan
Medical Corporation JR Hiroshima Hospital
Hiroshima, Hirosima [Hiroshima], Japan
Kotoni Medical Support Clinic
Sapporo, Hokkaidô [Hokkaido], Japan
Tenjin Sogo Clinic
Fukuoka, Hukuoka [Fukuoka], Japan
Matsuba Clinic
Kawasaki-shi, Kanagawa, Japan
Hayashi-Katagihara Clinic
Kyoto, Kyôto [Kyoto], Japan
Yokoi Medicine Clinic
Minoh, Osaka, Japan
Asano Clinic
Kawagoe-shi, Saitama, Japan
Omi Medical Center
Yabasecho, Shiga, Japan
Dojinkinenkai Meiwa Hospital
Chiyoda-ku, Tôkyô [Tokyo], Japan
Nihonbashi Sakura Clinic
Chūōku, Tôkyô [Tokyo], Japan
Medical Corporation Asbo Tokyo Asbo Clinic
Minatoku, Tôkyô [Tokyo], Japan
Tokyo Saiseikai Central Hospital
Minatoku, Tôkyô [Tokyo], Japan
Denenchofu Family Clinic
Ōta-ku, Tôkyô [Tokyo], Japan
Higashi-Shinjuku Clinic - Internal Medicine
Shinjuku-ku, Tôkyô [Tokyo], Japan
Shimamura Memorial Hospital
Suginami City, Tôkyô [Tokyo], Japan
P-one Clinic
Hachiōji, Tôkyô, Japan
Sasaki Clinic
Hyōgo, Japan
NewHeart Watanabe Institute
Kanazawa, Japan
Izumino Hospital
Kochi, Japan
Sapporo Odori Endoscopy Clinic
Sapporo, Japan
Takatsuki General Hosiptal
Takatsuki-shi, Japan
CEVAXIN David
David, Chiriquí Province, Panama
CEVAXIN Chorrera
La Chorrera, Panama
CEVAXIN 24 de Diciembre
Panama City, Panama
CEVAXIN Avenida Mexico
Panama City, Panama
BRCR Global
Ponce, 00717, Puerto Rico
Clinical Research Puerto Rico, Inc.
San Juan, 00909-1711, Puerto Rico
Research Works San Juan
San Juan, 00966, Puerto Rico
Velocity Clinical Research - High Wycombe
High Wycombe, Buckinghamshire, United Kingdom
Warrington and Halton Teaching Hospitals NHS Foundation Trust - Halton General Hospital
Runcorn, Cheshire, United Kingdom
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
St George's University Hospitals NHS Foundation Trust - St George's Hospital
London, England, United Kingdom
Accellacare South London
Orpington, Kent, United Kingdom
Layton Medical Centre
Blackpool, Lancashire, United Kingdom
Panthera Biopartners - Manchester
Rochdale, Manchester, United Kingdom
Northern Care Alliance NHS Foundation Trust - Salford Royal Hospital
Salford, Manchester, United Kingdom
Lakeside Healthcare
Corby, Northamptonshire, United Kingdom
Eynsham Medical Center
Witney, Oxfordshire, United Kingdom
NHS Grampian - Aberdeen Royal Infirmary
Aberdeen, United Kingdom
NIHR Welcome Trust Clinical Research Facility
Birmingham, United Kingdom
Bournemouth Research Hub
Bournemouth, United Kingdom
North Bristol NHS Trust - Southmead Hospital
Bristol, United Kingdom
Cardiff and Vale University Health Board - University Hospital Wales
Cardiff, United Kingdom
Accellacare Warwickshire Quality Research Site
Coventry, United Kingdom
NHS Lothian - Western General Hospital
Edinburgh, United Kingdom
Panthera Biopartners - North London
Enfield, United Kingdom
Royal Devon & Exeter Hospital (Wonford)
Exeter, United Kingdom
CPS Research by FutureMeds
Glasgow, United Kingdom
Glasgow Clinical Research Facility
Glasgow, United Kingdom
Panthera Biopartners - Glasgow
Glasgow, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
FutureMeds Wirral
Liverpool, United Kingdom
Mile End Hospital
London, United Kingdom
Royal Free London NHS Foundation Trust - Royal Free Hospital
London, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
FutureMeds Newcastle
Newcastle upon Tyne, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
Leeds Teaching Hospitals NHS Trust - St James' University Hospital
Nottingham, United Kingdom
Plymouth Hospital NHS trust-Derriford Hospital
Plymouth, United Kingdom
Portsmouth Research Hub
Portsmouth, United Kingdom
Panthera Biopartners - Sheffield
Sheffield, United Kingdom
Accellacare Yorkshire Quality Research Site
Shipley, United Kingdom
Wansford Research Ltd
Wansford, United Kingdom
Weymouth Research Hub
Weymouth, United Kingdom
Windrush Medical Practice
Witney, United Kingdom
North Wales Clinical Research Centre (NWCRC)
Wrexham, United Kingdom
Panthera Biopartners - York
York, United Kingdom
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 9, 2024
First Posted
September 19, 2024
Study Start
September 24, 2024
Primary Completion (Estimated)
February 15, 2027
Study Completion (Estimated)
February 15, 2027
Last Updated
February 25, 2026
Record last verified: 2026-02