Phase
Condition
Gastroenteritis
Treatment
mRNA-1403
mRNA-1405
Placebo
Clinical Study ID
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Part A Phase 1: Adults 18 to 49 years of age at the time of consent or adults 60 to 80 years of age at the time of consent.
Part B Phase 2 and Part C Phase 2: Adults 18 to 80 years of age at the time ofconsent.
Body mass index of 18 to 39 kilogram/meter^2 (inclusive) at the Screening Visit.
Participants assigned female at birth are eligible to participate if they are notpregnant or breast/chest/body feeding.
A person of childbearing potential is using a highly effective contraceptive method.
Participant has provided written informed consent for participation in this study.
Exclusion
Key Exclusion Criteria:
Is acutely ill or febrile (temperature ≥38.0°C [100.4°F]) 72 hours prior to or atthe Screening Visit or Day 1.
Part B Phase 2 booster extension period: acute disease or febrile 72 hours prior toor on Day 365.
History of a diagnosis or condition that, in the judgment of the Investigator, isclinically unstable or may affect participant safety, assessment of safetyendpoints, assessment of immune response, or adherence to study procedures.
Has a medical, psychiatric, or occupational condition, including reported history ofsubstance abuse, which may pose additional risk as a result of participation, orthat could interfere with safety assessments or interpretation of results accordingto the Investigator's judgment.
Has a current or previous diagnosis of immunosuppressive condition, to include humanimmunodeficiency virus, or immune-mediated (autoimmune) disease that requiresimmunosuppressive therapies.
(drugs or biologics). The use of topical corticosteroids or other immunosuppressive agents (for example, topical calcineurin inhibitor) may be eligible for participation at the discretion of the Investigator.
History of anaphylaxis, urticaria, or other significant AR requiring medicalintervention after receipt of a vaccine or intervention that includes one or more ofthe same components contained in the study vaccine.
Part A Phase 1 and Part B Phase 2 base period: Any history of myocarditis orpericarditis.
Part B Phase 2 booster extension period and Part C Phase 2: Any history ofmyocarditis, pericarditis, or Guillain-Barré Syndrome.
Coagulopathy or bleeding disorder considered a contraindication to IM injection orphlebotomy.
Dermatologic conditions that could affect local solicited AR assessments (forexample, tattoos, psoriasis patches affecting skin over the deltoid areas).
Has received systemic immunosuppressive therapies (drugs or biologics) for >14 daysin total within 6 months prior to Screening or Day 365 (Part B Phase 2 boosterextension period only) (for corticosteroids ≥10 mg/day of prednisone equivalent) oris anticipating the need for immunosuppressive treatment at any time duringparticipation in the study. Inhaled, nasal, intra-articular, and topical steroidsare allowed.
Has received or plans to receive any licensed/authorized vaccine (to include severeacute respiratory syndrome-related coronavirus-2 vaccine) ≤28 days prior to orwithin 28 days after each study intervention, with the exception of influenzavaccines, which may be given 14 days before or after receipt of a studyintervention.
Has received systemic immunoglobulins or blood products within 3 months prior toScreening or Day 365 (Part B Phase 2 booster extension period only) or plans forreceipt during the study.
Has donated protocol-specified volume of blood products within protocol-specifiedtimeframe.
Participated or plans to participate in an interventional clinical study withinprotocol-specified timeframe.
Part B Phase 2: Individuals who are participating/have participated in the Part APhase 1 part of the study are excluded.
Part A Phase 1: Any individual with laboratory abnormalities achieving thresholdsdefined in the protocol.
Part C Phase 2: Individuals who have received an experimental NoV vaccine areexcluded, including but not limited to individuals who are participating/haveparticipated in Part A Phase 1 or Part B Phase 2 of the current study, or who areparticipating/have participated in mRNA-1403-P.301.
Study Design
Connect with a study center
Emeritus Research Camberwell
Camberwell,
AustraliaSite Not Available
Emeritus Research Camberwell
Camberwell 2172686,
AustraliaSite Not Available
Nucleus Network
Melbourne,
AustraliaSite Not Available
Nucleus Network
Melbourne 2158177,
AustraliaSite Not Available
ARK Clinical Research, LLC
Long Beach, California 90815
United StatesSite Not Available
ARK Clinical Research, LLC
Long Beach 5367929, California 5332921 90815
United StatesSite Not Available
Tekton Research, Inc - Longmont Center
Longmont, Colorado 80501
United StatesSite Not Available
Tekton Research, Inc - Longmont Center
Longmont 5579276, Colorado 5417618 80501
United StatesSite Not Available
Research Centers of America
Hollywood, Florida 33024
United StatesSite Not Available
Research Centers of America
Hollywood 4158928, Florida 4155751 33024
United StatesSite Not Available
Accel Research Sites Network
Decatur, Georgia 30030
United StatesSite Not Available
Accel Research Sites Network
Decatur 4191124, Georgia 4197000 30030
United StatesSite Not Available
Velocity Clinical Research - Boise
Meridian, Idaho 83642
United StatesSite Not Available
Velocity Clinical Research - Boise
Meridian 5600685, Idaho 5596512 83642
United StatesSite Not Available
Optimal Research
Peoria, Illinois 61614
United StatesSite Not Available
Optimal Research
Peoria 4905687, Illinois 4896861 61614
United StatesSite Not Available
Velocity Clinical Research - Boise
Meridian Hills, Indiana 83642
United StatesSite Not Available
Meridian Clinical Research, LLC
Sioux City, Iowa 51106
United StatesSite Not Available
Velocity Clinical Research
Sioux City, Iowa 51106
United StatesSite Not Available
Velocity Clinical Research
Sioux City 4876523, Iowa 4862182 51106
United StatesSite Not Available
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas 66219
United StatesSite Not Available
Johnson County Clin-Trials (JCCT)
Lenexa 4274356, Kansas 4273857 66219
United StatesSite Not Available
Rockville Internal Medicine Group
Rockville, Maryland 20854
United StatesSite Not Available
Velocity Clinical Research
Rockville, Maryland 20854
United StatesSite Not Available
Velocity Clinical Research
Rockville 4367175, Maryland 4361885 20854
United StatesSite Not Available
Meridian Clinical Research, LLC
Norfolk, Nebraska 68701
United StatesSite Not Available
Velocity Clinical Research
Norfolk, Nebraska 68701
United StatesSite Not Available
Velocity Clinical Research
Omaha, Nebraska 68134
United StatesSite Not Available
Velocity Clinical Research
Norfolk 5073965, Nebraska 5073708 68701
United StatesSite Not Available
Velocity Clinical Research
Omaha 5074472, Nebraska 5073708 68134
United StatesSite Not Available
Rochester Clinical Research, Inc
Rochester, New York 14609
United StatesSite Not Available
Rochester Clinical Research, Inc
Rochester 5134086, New York 5128638 14609
United StatesSite Not Available
C & R Research Services USA / HHBA Health LLC
Houston, Texas 77054
United StatesSite Not Available
Epic Medical Research, LLC
Red Oak, Texas 75154
United StatesSite Not Available
Epic Medical Research, LLC
Red Oak 4721921, Texas 4736286 75154
United StatesSite Not Available
JBR Clinical Research
Salt Lake City, Utah 84107
United StatesSite Not Available
JBR Clinical Research
Salt Lake City 5780993, Utah 5549030 84107
United StatesSite Not Available

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