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) and/or 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 Seroconversion of B-Cell nAbs and/or Antigen-Specific bAbs
The number of initially EBV-negative participants with seroconversion from below the lower limit of quantification (LLOQ) to above the LLOQ for EBV-specific (vaccine antigen) binding and nAbs responses and the initially EBV-positive participants with \> 2-, 3-, and 4-fold increases in serum binding or nAb titers from baseline (if above LLOQ) will be analyzed.
Time frame: Days 1, 85, and 197
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Medical Affiliated Research Institute
Huntsville, Alabama, United States
Alliance for Multispecialty Research, LLC
Tempe, Arizona, United States
Smart Cures Clinical Research
Anaheim, California, United States
Benchmark Research - Colton - HyperCore - PPDS
Colton, California, United States
Fomat Medical Research
Oxnard, California, United States
Center For Clinical Trials LLC -Paramount
Paramount, California, United States
Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS
Riverside, California, United States
Peninsula Research Associates - Headlands Research - PPDS
Rolling Hills, California, United States
Velocity Clinical Research - Banning - PPDS
San Bernardino, California, United States
Acclaim Clinical Research
San Diego, California, United States
...and 55 more locations