Status and phase
Conditions
Treatments
About
The primary objectives of this study are to evaluate the tolerability and reactogenicity of a single injection of up to 5 dose levels of mRNA-1345 in younger adults, women of child-bearing potential, and older adults including Japanese older adults; of 3 injections of the middle dose level of mRNA-1345 given 56 days apart in younger adults; of a booster injection of mRNA-1345 given approximately 12 and 24 months after the primary injection in older adults; and of 3 injections of 1 of 2 dose levels of mRNA-1345 given 56 days apart in children who are RSV-seropositive.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Specific inclusion criteria for adults (younger adults, women of child-bearing potential, and older adults [including Japanese older adults]):
Specific inclusion criteria for children 12 to 59 months of age:
Specific inclusion criteria for Japanese older adults:
Key Exclusion Criteria:
Has Screening laboratory values Grade ≥1 (younger adult, women of child-bearing potential, and pediatric participants) or >Grade 1 (older adult participants, including Japanese older adult participants).
Is acutely ill or febrile on the day of the first injection.
Has a significant medical history, including but not limited to:
Has received or plans to receive any licensed or authorized vaccine, to include COVID-19 vaccines, ≤ 28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study vaccine injection, with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study vaccine injection. Nonstudy vaccinations should not be delayed.
Has a history of myocarditis, pericarditis, or myopericarditis.
Specific exclusion criteria for older adults (Cohorts 7-11 and 15):
Specific exclusion criteria for children 12 to 59 months of age (Cohorts 5 and 6):
Primary purpose
Allocation
Interventional model
Masking
651 participants in 15 patient groups
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Data sourced from clinicaltrials.gov
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