Clinical trial NCT06592794: A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Gastroenteritis
Norovirus Acute Gastroenteritis
Keywords: Acute Gastroenteritis
Norovirus Acute Gastroenteritis
mRNA-1403
Viral Gastroenteritis
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 25000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. 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.
4. Participants assigned female at birth are eligible to participate if they are not pregnant or breastfeeding/chestfeeding/bodyfeeding and meet protocol defined criteria.

Exclusion Criteria:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. Reported history of congenital or acquired immunodeficiency, immunocompromising/immunosuppressive condition, asplenia, or recurrent severe infections per protocol.
8. 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.
9. History of myocarditis, pericarditis, or myopericarditis with onset within 180 days prior to Day 1 whose values have not returned to Baseline clinical status.
10. History of Guillain-Barré syndrome.
11. Reported history of coagulopathy or bleeding disorder considered a contraindication to IM injection or phlebotomy.
12. Dermatologic conditions that could affect local solicited AR assessments.
13. Diagnosis of malignancy within the previous 2 years (excluding nonmelanoma skin cancer).
14. 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.
15. 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.
16. Receipt of systemic immunoglobulins or blood products within 3 months prior to Day 1 or plans for receipt during the study.
17. Has donated ≥450 mL of blood products within 28 days prior to Day 1 Visit or plans to donate blood products during the study.
18. 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. Participants may continue in prior interventional study follow-up activities, provided that it does not involve further investigational treatment and/or procedures that may affect safety and/or other study endpoints, and study participation does not result in a breach of either study protocol.
19. Is working as, has worked as, or is an immediate family member or household member of study personnel, Sponsor personnel, or study site staff directly involved with the conduct of the study.

Primary outcomes:
measure: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: Day 1 up to Day 7 (7 days after study intervention)
measure: Number of Participants with Unsolicited Adverse Events (AEs)
timeFrame: Day 1 up to Day 28 (28 days after study intervention)
measure: Number of Participants with Medically Attended Adverse Events (MAAEs)
timeFrame: Day 1 through Day 181
measure: Number of Participants with Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal
timeFrame: Day 1 through Day 730
measure: Vaccine Efficacy (VE) of mRNA-1403 to Prevent First Occurrence of Protocol-defined Moderate or Severe AGE Associated with Vaccine Matched Genotypes
timeFrame: Day 15 through Day 730
Secondary outcomes:
measure: VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Severe AGE Associated with Vaccine Matched Genotypes
timeFrame: Day 15 through Day 730
measure: VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Norovirus (NoV) AGE of Any Severity Associated with Vaccine Matched Genotypes
timeFrame: Day 15 through Day 730
measure: VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Moderate or Severe AGE Associated with Any Genogroup I or II NoV Genotype
timeFrame: Day 15 through Day 730
measure: VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Severe AGE Associated with Any Genogroup I or II NoV Genotype
timeFrame: Day 15 through Day 730
measure: VE of mRNA-1403 to Prevent Any Occurrence of Medically Attended AGE Associated with Vaccine Matched Genotypes, as well as any Genogroup I or II NoV Genotype
timeFrame: Day 15 through Day 730
measure: VE of mRNA-1403 to Prevent Any Occurrence of AGE Hospitalizations Associated With Vaccine Matched Genotypes, as well as any Genogroup I or II NoV Genotype
timeFrame: Day 15 through Day 730
measure: VE of mRNA-1403 to Prevent Any Occurrence of Protocol-defined Moderate or Severe AGE Associated with Vaccine Matched Genotypes
timeFrame: Day 15 through Day 730
measure: VE of mRNA-1403 to Prevent Any Occurrence of Protocol-defined AGE of Any Severity Associated with Any Genogroup I or II NoV Genotype
timeFrame: Day 15 through Day 730
measure: Geometric Mean Titer (GMT) of Histo-blood Group Antigen (HBGA)-blocking Antibodies Titers Against Vaccine Matched Genotypes
timeFrame: Day 1 and Day 29
measure: Geometric Mean Fold Rise (GMFR) of HBGA-blocking Antibodies Titers Against Vaccine Matched Genotypes
timeFrame: Day 1 and Day 29
measure: Percentage of Participants with Seroresponse Based on HBGA-blocking Antibody Titer
timeFrame: Day 29
measure: GMT of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes
timeFrame: Day 1 and Day 29
measure: GMFR of bAb Titers
timeFrame: Day 1 and Day 29
measure: Percentage of Participants with Seroresponse Based on bAb Titer
timeFrame: Day 29
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Accel Research Sites - Achieve Clinical Research
state: Alabama
city: Cullman
country: United States
facility: Cullman Clinical Trials
state: Alabama
city: Daphne
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Alabama
city: Phoenix
country: United States
facility: ClinMed, LLC
state: Arizona
city: Phoenix
country: United States
facility: DM Clinical - Phoenix
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Phoenix
country: United States
facility: Abby's Research Institute
state: Arizona
city: Scottsdale
country: United States
facility: Headlands Research Scottsdale
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Clinical Trials
state: Arizona
city: Tempe
country: United States
facility: Hope Research Institute - Tempe
state: Arizona
city: Tucson
country: United States
facility: Arizona Liver Health
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical and Research Center
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management LLC.- Tucson
state: Arizona
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks
state: Arkansas
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Fountain Valley
country: United States
facility: ARK Clinical Research, LLC
state: California
city: Fullerton
country: United States
facility: ASCADA Research, LLC - Family Medicine
state: California
city: Huntington Park
country: United States
facility: Matrix Clinical Research
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research, San Diego
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research
state: California
city: Los Angeles
country: United States
facility: Matrix Clinical Research
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research - Westlake
state: California
city: Redding
country: United States
facility: Paradigm Research
state: California
city: Riverside
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Riverside
country: United States
facility: Benchmark Research
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates (PRA)
state: California
city: San Diego
country: United States
facility: Apex Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Aurora
country: United States
facility: Lynn Institute of Denver
state: Colorado
city: Fort Collins
country: United States
facility: Tekton Research - Fort Collins
state: Colorado
city: Longmont
country: United States
facility: Tekton Research, Inc - Longmont Center
state: Colorado
city: Boynton Beach
country: United States
facility: Imagine Research of Palm Beach County
state: Florida
city: Coral Gables
country: United States
facility: Pioneer Clinical Studies
state: Florida
city: Doral
country: United States
facility: Integrity Clinical Research, LLC (ICR SITES) - Doral
state: Florida
city: Doral
country: United States
facility: Alliance for multispecialty Research - Florida
state: Florida
city: Hialeah
country: United States
facility: AGA Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Best Quality Research Inc.
state: Florida
city: Hialeah
country: United States
facility: Neoclinical Research
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research, LLC - Inverness
state: Florida
city: Jacksonville
country: United States
facility: Westside Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Jupiter
country: United States
facility: Health Awareness INC
state: Florida
city: Lake Mary
country: United States
facility: University Clinical Research- Deland
state: Florida
city: Lakeland
country: United States
facility: Meridien Research
state: Florida
city: Leesburg
country: United States
facility: Clinical Site Partners - Leesburg
state: Florida
city: Maitland
country: United States
facility: Accel Clinical Research - Maitland
state: Florida
city: Miami
country: United States
facility: Dade Research Center, LLC
state: Florida
city: Miami
country: United States
facility: Miami Clinical Research
state: Florida
city: Miami
country: United States
facility: Universal Axon Clinical Research
state: Florida
city: Miami
country: United States
facility: Florida International Research Center
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates, LLC
state: Florida
city: Miami
country: United States
facility: Miami Dade Medical Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: Felicidad Medical Research
state: Florida
city: Naples
country: United States
facility: Aqualane Clinical Research
state: Florida
city: New Port Richey
country: United States
facility: SUNCOAST Clinical Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Port Orange
country: United States
facility: United Medical Research
state: Florida
city: Port Saint Lucie
country: United States
facility: Health Awareness, Inc
state: Florida
city: Saint Augustine
country: United States
facility: St. Johns Center for Clinical Research
state: Florida
city: Saint Petersburg
country: United States
facility: IMA Clinical Research - St. Petersburg
state: Florida
city: Saint Petersburg
country: United States
facility: Global Clinical Professionals, LLC
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research, LLC
state: Florida
city: Albany
country: United States
facility: Albany Internal Medicine
state: Georgia
city: Atlanta
country: United States
facility: Delricht Research At Springer Wellness And Restorative Health
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Decatur
country: United States
facility: CenExel iResearch Atlanta, LLC
state: Georgia
city: Fayetteville
country: United States
facility: Javara Inc.
state: Georgia
city: Savannah
country: United States
facility: Fellows Research Alliance, Inc.
state: Georgia
city: Savannah
country: United States
facility: Velocity Clinical Research-Savannah
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta/Headlands
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Meridian
country: United States
facility: Velocity Clinical Research - Boise
state: Idaho
city: Chicago
country: United States
facility: IMA Clinical Research
state: Illinois
city: Gurnee
country: United States
facility: Great Lakes Clinical Trials - Gurnee
state: Illinois
city: Naperville
country: United States
facility: Bioluminix Clinical Research Chicago
state: Illinois
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: River Forest
country: United States
facility: DM Clinical Research- River Forest
state: Illinois
city: Valparaiso
country: United States
facility: Velocity Clinical Research - Valparaiso
state: Indiana
city: Sioux City
country: United States
facility: Velocity Clinical Research-Sioux City
state: Iowa
city: Lenexa
country: United States
facility: Johnson County Clin-Trials (JCCT)
state: Kansas
city: Overland Park
country: United States
facility: Velocity Clinical Research- Kansas City
state: Kansas
city: Wichita
country: United States
facility: Tekton Research
state: Kansas
city: Lexington
country: United States
facility: AMR Lexington
state: Kentucky
city: Baton Rouge
country: United States
facility: Velocity Clinical Research - Baton Rouge
state: Louisiana
city: Covington
country: United States
facility: Velocity Clinical Research - Covington
state: Louisiana
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: Annapolis
country: United States
facility: Privia Medical Group
state: Maryland
city: Gaithersburg
country: United States
facility: Cenexel CBH (CBH Health)
state: Maryland
city: Rockville
country: United States
facility: Velocity Clinical Research-Rockville
state: Maryland
city: Silver Spring
country: United States
facility: Javara Inc/Privia Medical Group, LLC
state: Maryland
city: Brookline
country: United States
facility: DM Clinical Research - Brookline
state: Massachusetts
city: Burlington
country: United States
facility: Skylight Health Research - Burlington
state: Massachusetts
city: Southfield
country: United States
facility: Headlands Research - Detroit
state: Michigan
city: Southfield
country: United States
facility: Great Lakes Research Institute
state: Michigan
city: Southfield
country: United States
facility: DM Clinical Research - Southfield
state: Michigan
city: Troy
country: United States
facility: Oakland Medical Research Center
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Gulfport
country: United States
facility: Velocity Clinical Research, Gulfport
state: Mississippi
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Springfield
country: United States
facility: Clinvest Headlands LLC
state: Missouri
city: Springfield
country: United States
facility: Delricht Research
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research, Inc
state: Montana
city: Lincoln
country: United States
facility: Velocity Clinical Research-Lincoln
state: Nebraska
city: Norfolk
country: United States
facility: Velocity Clinical Research-Norfolk
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research-Omaha
state: Nebraska
city: Carson City
country: United States
facility: Javara Inc. / Nevada Health Centers, Ind
state: Nevada
city: Las Vegas
country: United States
facility: Vector Clinical Trials
state: Nevada
city: Las Vegas
country: United States
facility: Oasis Clinical Research
state: Nevada
city: Jersey City
country: United States
facility: DM Clinical Research - New Jersey
state: New Jersey
city: Warren
country: United States
facility: IMA Clinical Research Warren
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials (ACT)
state: New Mexico
city: Albuquerque
country: United States
facility: DM Clinical Research
state: New Mexico
city: Albuquerque
country: United States
facility: Velocity Clinical Research- Albuquerque
state: New Mexico
city: Binghamton
country: United States
facility: Velocity Clinical Research - Binghamton
state: New York
city: Brooklyn
country: United States
facility: DM Clinical - Brooklyn
state: New York
city: Brooklyn
country: United States
facility: Brooklyn Clinical Research
state: New York
city: East Syracuse
country: United States
facility: Velocity Clinical Research - Syracuse
state: New York
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc
state: New York
city: Vestal
country: United States
facility: Velocity Clinical Research-Vestal
state: New York
city: Charlotte
country: United States
facility: DelRicht Research, LLC
state: North Carolina
city: Charlotte
country: United States
facility: Javara Inc. - Tryon Medical-South Park
state: North Carolina
city: Durham
country: United States
facility: Velocity Clinical Research, Durham
state: North Carolina
city: Morehead City
country: United States
facility: West Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: Accellacare Raleigh
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare of Wilmington
state: North Carolina
city: Winston-Salem
country: United States
facility: Javara - Wake Forest University Health Sciences
state: North Carolina
city: Beachwood
country: United States
facility: Velocity Clinical Research, Cleveland
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research-Mt. Auburn
state: Ohio
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Reseach - Blue Ash
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research - Cincinnati OH
state: Ohio
city: Columbus
country: United States
facility: Centricity Research
state: Ohio
city: Columbus
country: United States
facility: Remington-Davis Clinical Research
state: Ohio
city: Edmond
country: United States
facility: Tekton Research, Inc - Edmond
state: Oklahoma
city: Tulsa
country: United States
facility: Delricht Tate
state: Oklahoma
city: Yukon
country: United States
facility: Tekton Research, Inc - Yukon Location
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research - Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: DM Clinical Research
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research - Providence
state: Rhode Island
city: Anderson
country: United States
facility: Velocity Clinical Research - Anderson
state: South Carolina
city: Charleston
country: United States
facility: DelRicht Research
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center - North Charleston
state: South Carolina
city: Spartanburg
country: United States
facility: Velocity Clinical Research, Spartanburg
state: South Carolina
city: Bristol
country: United States
facility: PMG Research of Bristol, LLC
state: Tennessee
city: Hendersonville
country: United States
facility: Delricht Moyer
state: Tennessee
city: Memphis
country: United States
facility: CNS Healthcare DBA Clinical Neuroscience Solutions, INC
state: Tennessee
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Austin
country: United States
facility: IMA Clinical Research Austin
state: Texas
city: Beaumont
country: United States
facility: Tekton Research, Inc. - Beaumont
state: Texas
city: Brownsville
country: United States
facility: Headlands Research Brownsville
state: Texas
city: Carrollton
country: United States
facility: Family Medicine Associates of Texas
state: Texas
city: Conroe
country: United States
facility: Javara Inc (Conroe)
state: Texas
city: Dallas
country: United States
facility: WR-Global Medical Research, LLC
state: Texas
city: El Paso
country: United States
facility: El Paso Research
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research Service
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - CyFair
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Bellaire
state: Texas
city: Irving
country: United States
facility: DM Clinical Research - Irving
state: Texas
city: Plano
country: United States
facility: ACRC Trials
state: Texas
city: Plano
country: United States
facility: Research Your Health
state: Texas
city: Prosper
country: United States
facility: Delricht Research At Zomnir Family Medicine
state: Texas
city: San Antonio
country: United States
facility: DM Clinical Research - San Antonio
state: Texas
city: San Antonio
country: United States
facility: IMA Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Tekton Research Inc - San Antonio
state: Texas
city: Sugar Land
country: United States
facility: DM Clinical Research - Sugarland
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - Tomball
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Bountiful
country: United States
facility: Cope Family Medicine
state: Utah
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center, LLC
state: Virginia
city: Hampton
country: United States
facility: Velocity Clinical Research - Hampton
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads
state: Virginia
city: Norfolk
country: United States
facility: AMR Norfolk
state: Virginia
city: Portsmouth
country: United States
facility: Velocity Clinical Research-Portsmouth
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Seattle
country: United States
facility: DM Clinical Research - Seattle
state: Washington
city: Kingwood
country: United States
facility: Frontier Clinical Research, LLC
state: West Virginia
city: Bruce
country: Australia
facility: Paratus Clinical Research Canberra
state: Australian Capital Territory
city: Coffs Harbour
country: Australia
facility: Northside Health
state: New South Wales
city: Darlinghurst
country: Australia
facility: Momentum Clinical Research Darlinghurst
state: New South Wales
city: Kanwal
country: Australia
facility: Paratus Clinical Research Central Coast
state: New South Wales
city: Maroubra
country: Australia
facility: Australian Clinical Research Network
state: New South Wales
city: Herston
country: Australia
facility: Paratus Clinical Research Brisbane
state: Queensland
city: Southport
country: Australia
facility: Griffith University Hospital
state: Queensland
city: Norwood
country: Australia
facility: Fusion Clinical Research
state: South Australia
city: Bayswater
country: Australia
facility: Veritus Research
state: Victoria
city: Camberwell
country: Australia
facility: Emeritus Research (Melbourne)
state: Victoria
city: North Melbourne
country: Australia
facility: The Peter Doherty Institute for Infection & Immunity
state: Victoria
city: Calgary
country: Canada
facility: CARe Clinic
city: Chicoutimi
country: Canada
facility: Intermed Groupe Sante
city: Guelph
country: Canada
facility: Apex Trials
city: Halifax
country: Canada
facility: Isaak Walton Killam Health Centre
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials
city: Levis
country: Canada
facility: Centricity Research Quebec City
city: London
country: Canada
facility: Milestone Research Inc.
city: Mirabel
country: Canada
facility: Centricity Research Mirabel
city: Pointe-Claire
country: Canada
facility: Centricity Research Pointe-Claire
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Québec
country: Canada
facility: Clinique Spécialisée en Allergie de la Capitale
city: Red Deer
country: Canada
facility: CARe Clinic Red Deer
city: Richmond
country: Canada
facility: Richmond Clinical Trials
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group, Inc
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc
city: Sudbury
country: Canada
facility: Medicor Research Inc.
city: Toronto
country: Canada
facility: Centricity Research Toronto LMC
city: Trois-Rivieres
country: Canada
facility: Diex Recherche Trois-Rivières
city: Truro
country: Canada
facility: Colchester Research Group
city: Nagoya
country: Japan
facility: Chubu Rosai Hospital - Rheumatology & Collageous
state: Aichi
city: Nagoya
country: Japan
facility: Daido clinic
state: Aichi
city: Hiroshima-shi
country: Japan
facility: Medical Corporation JR Hiroshima Hospital
state: Hirosima [Hiroshima]
city: Sapporo
country: Japan
facility: Kotoni Medical Support Clinic
state: Hokkaidô [Hokkaido]
city: Fukuoka-shi
country: Japan
facility: Tenjin Sogo Clinic
state: Hukuoka [Fukuoka]
city: Kawasaki-shi
country: Japan
facility: Matsuba Clinic
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Hayashi-Katagihara Clinic
state: Kyôto [Kyoto]
city: Minoh
country: Japan
facility: Yokoi Medicine Clinic
state: Osaka
city: Kawagoe-shi
country: Japan
facility: Asano Clinic
state: Saitama
city: Yabasecho
country: Japan
facility: Omi Medical Center
state: Shiga
city: Chiyoda-ku
country: Japan
facility: Dojinkinenkai Meiwa Hospital
state: Tôkyô [Tokyo]
city: Chuo-ku
country: Japan
facility: Nihonbashi Sakura Clinic
state: Tôkyô [Tokyo]
city: Minato-Ku
country: Japan
facility: Medical Corporation Asbo Tokyo Asbo Clinic
state: Tôkyô [Tokyo]
city: Minato-Ku
country: Japan
facility: Tokyo Saiseikai Central Hospital
state: Tôkyô [Tokyo]
city: Ota
country: Japan
facility: Denenchofu Family Clinic
state: Tôkyô [Tokyo]
city: Shinjuku-ku
country: Japan
facility: Higashi-Shinjuku Clinic - Internal Medicine
state: Tôkyô [Tokyo]
city: Suginami
country: Japan
facility: Shimamura Memorial Hospital
state: Tôkyô [Tokyo]
city: Hachioji
country: Japan
facility: P-one Clinic
state: Tôkyô
city: Hyogo
country: Japan
facility: Sasaki Clinic
city: Kanazawa-shi
country: Japan
facility: NewHeart Watanabe Institute
city: Kochi
country: Japan
facility: Izumino Hospital
city: Sapporo-shi
country: Japan
facility: Sapporo Odori Endoscopy Clinic
city: Takatsuki-shi
country: Japan
facility: Takatsuki General Hosiptal
city: David
country: Panama
facility: CEVAXIN David
state: Chiriquí
city: Ciudad de Panamá
country: Panama
facility: CEVAXIN Avenida Mexico
city: La Chorrera
country: Panama
facility: CEVAXIN Chorrera
city: Panama City
country: Panama
facility: CEVAXIN 24 de Diciembre
city: Ponce
country: Puerto Rico
facility: BRCR Global
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico, Inc.
city: San Juan
country: Puerto Rico
facility: Research Works San Juan
city: High Wycombe
country: United Kingdom
facility: Velocity Clinical Research - High Wycombe
state: Buckinghamshire
city: Runcorn
country: United Kingdom
facility: Warrington and Halton Teaching Hospitals NHS Foundation Trust - Halton General Hospital
state: Cheshire
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
state: Cornwall
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust - St George's Hospital
state: England
city: Orpington
country: United Kingdom
facility: Accellacare South London
state: Kent
city: Blackpool
country: United Kingdom
facility: Layton Medical Centre
state: Lancashire
city: Rochdale
country: United Kingdom
facility: Panthera Biopartners - Manchester
state: Manchester
city: Salford
country: United Kingdom
facility: Northern Care Alliance NHS Foundation Trust - Salford Royal Hospital
state: Manchester
city: Corby
country: United Kingdom
facility: Lakeside Healthcare
state: Northamptonshire
city: Witney
country: United Kingdom
facility: Eynsham Medical Center
state: Oxfordshire
city: Aberdeen
country: United Kingdom
facility: NHS Grampian - Aberdeen Royal Infirmary
city: Birmingham
country: United Kingdom
facility: NIHR Welcome Trust Clinical Research Facility
city: Bournemouth
country: United Kingdom
facility: Bournemouth Research Hub
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust - Southmead Hospital
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University Health Board - University Hospital Wales
city: Coventry
country: United Kingdom
facility: Accellacare Warwickshire Quality Research Site
city: Edinburgh
country: United Kingdom
facility: NHS Lothian - Western General Hospital
city: Enfield Town
country: United Kingdom
facility: Panthera Biopartners - North London
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital (Wonford)
city: Glasgow
country: United Kingdom
facility: CPS Research by FutureMeds
city: Glasgow
country: United Kingdom
facility: Glasgow Clinical Research Facility
city: Glasgow
country: United Kingdom
facility: Panthera Biopartners - Glasgow
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: Liverpool
country: United Kingdom
facility: FutureMeds Wirral
city: London
country: United Kingdom
facility: Mile End Hospital
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust - Royal Free Hospital
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: FutureMeds Newcastle
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust - St James' University Hospital
city: Plymouth
country: United Kingdom
facility: Plymouth Hospital NHS trust-Derriford Hospital
city: Portsmouth
country: United Kingdom
facility: Portsmouth Research Hub
city: Sheffield
country: United Kingdom
facility: Panthera Biopartners - Sheffield
city: Shipley
country: United Kingdom
facility: Accellacare Yorkshire Quality Research Site
city: Wansford
country: United Kingdom
facility: Wansford Research Ltd
city: Weymouth
country: United Kingdom
facility: Weymouth Research Hub
city: Witney
country: United Kingdom
facility: Windrush Medical Practice
city: Wrexham
country: United Kingdom
facility: North Wales Clinical Research Centre (NWCRC)
city: York
country: United Kingdom
facility: Panthera Biopartners - York
Study officials:
References: