The purpose of this study is to evaluate the safety and immunogenicity in parallel of heptavalent mRNA-1975 and monovalent mRNA-1982 against Lyme disease in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
807
Clinical Research Consulting, LLC
Milford, Connecticut, United States
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 175 (7 days after each study injection)
Number of Participants With Unsolicited Adverse Events (AEs)
Time frame: Up to Day 196 (28 days after each study injection)
Number of Participants With Medically Attended AEs
Time frame: Day 1 through Day 337 (6 months after the last study injection)
Number of Participants with AEs of Special Interest, Serious AEs, and AEs Leading to Discontinuation of Study Injection or Study Participation
Time frame: Day 1 through Day 505 (End of Study)
Geometric Mean Concentration of Anti-outer Surface Protein A (anti-OspA) Binding Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay or a Similar Method
Time frame: Days 1, 29, 85, and 197
Geometric Mean Fold Rise of anti-OspA Binding IgG Antibody Concentration at Days 29, 85, and 197 Compared to Day 1 (Baseline)
Time frame: Days 29, 85, and 197
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