Clinical Research Partners, LLC | Forest Avenue, Richmond, VA
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About
The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1010, and to evaluate relative vaccine efficacy (rVE) of mRNA-1010 versus an active comparator against protocol-defined influenza-like illness (ILI) caused by any influenza A or B strains.
Enrollment
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Inclusion 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 who are assigned female at birth or can become pregnant are eligible to participate if:
Is not breast/chest feeding.
Is using an acceptable contraceptive method at least 28 days prior to Day 1 (Baseline) to at least 90 days after Day 1 (Baseline).
Has a negative highly sensitive pregnancy test (urine or serum as required by local regulation or institutional review board [IRB]/independent ethics committee [IEC]) at the Screening Visit and before study intervention (if the Day 1 [Baseline] Visit is not on the same day as the Screening Visit).
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
56,000 participants in 2 patient groups
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Central trial contact
Moderna Clinical Trials Support Center
Data sourced from clinicaltrials.gov
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