Phase
Condition
Gastroenteritis
Treatment
Placebo
mRNA-1403
mRNA-1405
Clinical Study ID
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Phase 1 Part: Adults 18 to 49 years of age at the time of consent or adults 60 to 80years of age at the time of consent.
Phase 2 Part: Adults 18 to 80 years of age at the time of consent.
Body mass index of 18 to 39 kilogram/meter^2 (inclusive) at the Screening Visit (relevant only for the base period of Phase 1 and Phase 2).
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.
Phase 2 Part booster extension period: acute disease or febrile 72 hours prior to oron 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.
Phase 1 Part and Phase 2 Part base period: Any history of myocarditis orpericarditis.
Phase 2 Part booster extension period: Any history of myocarditis, pericarditis, orGuillain-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 (Phase 2 Part 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 (Phase 2 Part 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.
Phase 2 Part: Individuals who are participating/have participated in the Phase 1part of the study are excluded.
Phase 1 Part: Any individual with laboratory abnormalities achieving thresholdsdefined in the protocol.
Study Design
Connect with a study center
ARK Clinical Research, LLC
Long Beach, California 90815
United StatesSite Not Available
Tekton Research, Inc - Longmont Center
Longmont, Colorado 80501
United StatesSite Not Available
Research Centers of America
Hollywood, Florida 33024
United StatesSite Not Available
Accel Research Sites Network
Decatur, Georgia 30030
United StatesSite Not Available
Velocity Clinical Research - Boise
Meridian, Idaho 83642
United StatesSite Not Available
Optimal Research
Peoria, Illinois 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
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas 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
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
Rochester Clinical Research, Inc
Rochester, New York 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
JBR Clinical Research
Salt Lake City, Utah 84107
United StatesSite Not Available
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