The main objective of Part A of this trial is to evaluate the safety and reactogenicity of mRNA-1189 in 18- to 30-year-old healthy adults, the main objective of Part B is to evaluate the safety and reactogenicity of mRNA-1189 in 12- to \<18-year-old healthy EBV-seronegative adolescents, and the main objective of Part C is to evaluate the safety and reactogenicity of mRNA-1189 in 10- to 21-year-old healthy adolescents and adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
867
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time frame: Up to Day 176 (7-day follow-up after vaccination)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 197 (28-day follow-up after vaccination)
Number of Participants with SAEs, MAAEs, Any AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine and AEs of Special Interest (AESIs)
Time frame: Day 1 to end of study (EOS) (Day 505)
Number of Participants with Laboratory Abnormalities
Time frame: Up to Day 176 (7-day follow-up after vaccination)
Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb)
Time frame: Days 1, 85, and 197
Geometric Mean Concentration (GMC) of Antigen-specific Binding Antibody (bAb)
Time frame: Days 1, 85, and 197
Geometric Mean Fold Rise (GMFR) of B-Cell nAb and Antigen-specific bAb
Time frame: Days 1, 85, and 197
Number of Participants with Seroresponse of B-Cell nAbs and Antigen-specific bAbs
The number of participants with seroresponse for EBV-specific (vaccine antigen) binding and nAbs responses and with \>2-, 3-, and 4-fold increases in serum binding or nAb titers from baseline will be analyzed with 2-sided 95% CI using the Clopper-Pearson method by treatment arm and baseline EBV serostatus, and timepoint.
Time frame: Days 1, 85, and 197
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