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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06592794




Registration number
NCT06592794
Ethics application status
Date submitted
9/09/2024
Date registered
19/09/2024
Date last updated
25/03/2025

Titles & IDs
Public title
A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants =18 Years of Age for the Prevention of Acute Gastroenteritis
Scientific 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
Secondary ID [1] 0 0
mRNA-1403-P301
Universal Trial Number (UTN)
Trial acronym
Nova 301
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Gastroenteritis 0 0
Norovirus Acute Gastroenteritis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - mRNA-1403
Treatment: Other - Placebo

Experimental: mRNA-1403 - Participants will receive a single injection of mRNA-1403 on Day 1.

Placebo comparator: Placebo - Participants will receive a single injection of mRNA-1403 matching placebo (0.9% sodium chloride solution) on Day 1.


Treatment: Other: mRNA-1403
Intramuscular (IM) injection.

Treatment: Other: Placebo
0.9% sodium chloride solution by IM injection.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Timepoint [1] 0 0
Day 1 up to Day 7 (7 days after study intervention)
Primary outcome [2] 0 0
Number of Participants with Unsolicited Adverse Events (AEs)
Timepoint [2] 0 0
Day 1 up to Day 28 (28 days after study intervention)
Primary outcome [3] 0 0
Number of Participants with Medically Attended Adverse Events (MAAEs)
Timepoint [3] 0 0
Day 1 through Day 181
Primary outcome [4] 0 0
Number of Participants with Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal
Timepoint [4] 0 0
Day 1 through Day 730
Primary outcome [5] 0 0
Vaccine Efficacy (VE) of mRNA-1403 to Prevent First Occurrence of Protocol-defined Moderate or Severe AGE Associated with Vaccine Matched Genotypes
Timepoint [5] 0 0
Day 15 through Day 730
Secondary outcome [1] 0 0
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Severe AGE Associated with Vaccine Matched Genotypes
Timepoint [1] 0 0
Day 15 through Day 730
Secondary outcome [2] 0 0
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Norovirus (NoV) AGE of Any Severity Associated with Vaccine Matched Genotypes
Timepoint [2] 0 0
Day 15 through Day 730
Secondary outcome [3] 0 0
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Moderate or Severe AGE Associated with Any Genogroup I or II NoV Genotype
Timepoint [3] 0 0
Day 15 through Day 730
Secondary outcome [4] 0 0
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Severe AGE Associated with Any Genogroup I or II NoV Genotype
Timepoint [4] 0 0
Day 15 through Day 730
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Day 15 through Day 730
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Day 15 through Day 730
Secondary outcome [7] 0 0
VE of mRNA-1403 to Prevent Any Occurrence of Protocol-defined Moderate or Severe AGE Associated with Vaccine Matched Genotypes
Timepoint [7] 0 0
Day 15 through Day 730
Secondary outcome [8] 0 0
VE of mRNA-1403 to Prevent Any Occurrence of Protocol-defined AGE of Any Severity Associated with Any Genogroup I or II NoV Genotype
Timepoint [8] 0 0
Day 15 through Day 730
Secondary outcome [9] 0 0
Geometric Mean Titer (GMT) of Histo-blood Group Antigen (HBGA)-blocking Antibodies Titers Against Vaccine Matched Genotypes
Timepoint [9] 0 0
Day 1 and Day 29
Secondary outcome [10] 0 0
Geometric Mean Fold Rise (GMFR) of HBGA-blocking Antibodies Titers Against Vaccine Matched Genotypes
Timepoint [10] 0 0
Day 1 and Day 29
Secondary outcome [11] 0 0
Percentage of Participants with Seroresponse Based on HBGA-blocking Antibody Titer
Timepoint [11] 0 0
Day 29
Secondary outcome [12] 0 0
GMT of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes
Timepoint [12] 0 0
Day 1 and Day 29
Secondary outcome [13] 0 0
GMFR of bAb Titers
Timepoint [13] 0 0
Day 1 and Day 29
Secondary outcome [14] 0 0
Percentage of Participants with Seroresponse Based on bAb Titer
Timepoint [14] 0 0
Day 29

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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-Barre 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2027
Actual
Sample size
Target
25000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research Canberra - Canberra
Recruitment hospital [2] 0 0
Northside Health - Coffs Harbour
Recruitment hospital [3] 0 0
Paratus Clinical Research Central Coast - Kanwal
Recruitment hospital [4] 0 0
Maroubra Medical Centre - Maroubra
Recruitment hospital [5] 0 0
Holdsworth House Medical Practice - Clinical Research - Sydney
Recruitment hospital [6] 0 0
Paratus Clinical Research Brisbane - Brisbane
Recruitment hospital [7] 0 0
Griffith University Hospital - Southport
Recruitment hospital [8] 0 0
CMAX Clinical Research - Adelaide
Recruitment hospital [9] 0 0
Veritus Research - Bayswater
Recruitment hospital [10] 0 0
Emeritus Research (Melbourne) - Camberwell
Recruitment hospital [11] 0 0
Vaccine and immunisation research group (VIRGo) - North Melbourne
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
- Coffs Harbour
Recruitment postcode(s) [3] 0 0
- Kanwal
Recruitment postcode(s) [4] 0 0
- Maroubra
Recruitment postcode(s) [5] 0 0
- Sydney
Recruitment postcode(s) [6] 0 0
- Brisbane
Recruitment postcode(s) [7] 0 0
- Southport
Recruitment postcode(s) [8] 0 0
- Adelaide
Recruitment postcode(s) [9] 0 0
- Bayswater
Recruitment postcode(s) [10] 0 0
- Camberwell
Recruitment postcode(s) [11] 0 0
- North Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
Country [16] 0 0
United States of America
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Massachusetts
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United States of America
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Michigan
Country [18] 0 0
United States of America
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Minnesota
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United States of America
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Mississippi
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United States of America
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Missouri
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Montana
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United States of America
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Nebraska
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Rhode Island
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South Carolina
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United States of America
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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United States of America
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West Virginia
Country [39] 0 0
Canada
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Calgary
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Chicoutimi
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Guelph
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Halifax
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Kelowna
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Levis
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London
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Mirabel
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Pointe-Claire
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Quebec
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Québec
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Red Deer
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Richmond
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Sarnia
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Sherbrooke
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Sudbury
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Trois-Rivieres
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Truro
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Aichi
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Hirosima [Hiroshima]
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Hokkaidô [Hokkaido]
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Hukuoka [Fukuoka]
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Kanagawa
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Japan
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Kyôto [Kyoto]
Country [64] 0 0
Japan
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Osaka
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Japan
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Saitama
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Japan
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Shiga
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Japan
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Tôkyô [Tokyo]
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Tôkyô
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Japan
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Hyogo
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Japan
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Kanazawa-shi
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Japan
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Kochi
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Japan
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Sapporo-shi
Country [73] 0 0
Japan
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Takatsuki-shi
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Panama
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Chiriquí
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Panama
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Ciudad de Panamá
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Panama
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La Chorrera
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Panama
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Panama City
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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United Kingdom
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Buckinghamshire
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Cheshire
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Cornwall
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England
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United Kingdom
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Kent
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United Kingdom
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Lancashire
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United Kingdom
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Manchester
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Northamptonshire
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United Kingdom
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Oxfordshire
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United Kingdom
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Aberdeen
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United Kingdom
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Birmingham
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United Kingdom
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Bournemouth
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United Kingdom
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Bristol
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United Kingdom
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Cardiff
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United Kingdom
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Coventry
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Edinburgh
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United Kingdom
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Enfield Town
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Exeter
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Glasgow
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Leicester
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Liverpool
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London
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United Kingdom
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Newcastle upon Tyne
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Nottingham
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Plymouth
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Portsmouth
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Sheffield
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Shipley
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United Kingdom
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Wansford
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Weymouth
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Witney
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United Kingdom
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Wrexham
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United Kingdom
State/province [112] 0 0
York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ModernaTX, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Moderna WeCare Team
Address 0 0
Country 0 0
Phone 0 0
1-866-663-3762
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06592794