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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
651
Formulation for injection
0.9% sodium chloride (normal saline) injection
Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
La Mesa, California, United States
Mills Clinical Research
West Hollywood, California, United States
Accel Research Site - Angel Kids Pediatrics - ERN - PPDS
DeLand, Florida, United States
Accel Research Sites - Nona Pediatric Center - ERN - PPDS
Orlando, Florida, United States
Palm Beach Research - ClinEdge - PPDS
West Palm Beach, Florida, United States
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 737 (7 days after each injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 758 (28 days after the last injection)
Number of Participants with Serious AEs or Medically Attended AEs (MAAEs)
Time frame: Up to Day 1095 (End of Study)
Geometric Mean Titer (GMT) of Serum RSV Neutralizing and Binding Antibodies (Abs)
Time frame: Up to Day 141 (Cohorts 5 and 6), up to Day 169 (Cohorts 1, 2, 4, 12, 13, 14, and 15), up to Day 281 (Cohort 3), and up to Day 1095 (Cohorts 7, 8, 9, 10, and 11)
Geometric Mean Fold-Rise of Postbaseline/Baseline Ab Titers
Time frame: Up to Day 141 (Cohorts 5 and 6), up to Day 169 (Cohorts 1, 2, 4, 12, 13, 14, and 15), up to Day 281 (Cohort 3), and up to Day 1095 (Cohorts 7, 8, 9, 10, and 11)
Proportion of Participants with ≥2-fold and ≥4-fold Increases in Ab Titers from Baseline
Time frame: Up to Day 141 (Cohorts 5 and 6), up to Day 169 (Cohorts 1, 2, 4, 12, 13, 14, and 15), up to Day 281 (Cohort 3), and up to Day 1095 (Cohorts 7, 8, 9, 10, and 11)
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Columbus, Georgia, United States
IResearch Atlanta LLC
Decatur, Georgia, United States
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Savannah, Georgia, United States
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Honolulu, Hawaii, United States
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Peoria, Illinois, United States
...and 21 more locations