Matrix Clinical Research | Los Angeles, CA
Status and phase
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About
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.
Enrollment
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Volunteers
Inclusion criteria
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:
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.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
25,000 participants in 2 patient groups, including a placebo group
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Central trial contact
Moderna Clinical Trials Support Center
Data sourced from clinicaltrials.gov
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