The purpose of this study is to evaluate the safety and reactogenicity of mRNA-1195 in healthy participants.
There will be 2 sequential parts to the study: * Participants 18 through 55 years of age will be enrolled in Part A of the study first, which will only enroll those participants who are EBV-seropositive at Screening. * Part B will enroll participants 18 through 30 years of age who are either EBV-seronegative or EBV-seropositive at Screening.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
482
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
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 Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Discontinuation of Study Intervention and/or Study Participation, and AEs of Special Interest (AESIs)
Time frame: Part A and B: Day 1 to end of study (EOS) (Part A: Day 337; Part B: Day 505)
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/or Antigen-Specific bAb
Time frame: Days 1, 85, and 197
Number of Participants With Seroresponse of B-Cell nAbs and/or Antigen-Specific bAbs
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.
0.9% sodium chloride (normal saline) injection
Sterile liquid for injection
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Noble Clinical Research
Tucson, Arizona, United States
Marvel Clinical Research
Huntington Beach, California, United States
Tekton Research
Longmont, Colorado, United States
Suncoast Research Group, LLC
Miami, Florida, United States
Velocity Clinical Research
Savannah, Georgia, United States
Optimal Research
Peoria, Illinois, United States
DM Clinical Research- River Forest
River Forest, Illinois, United States
Velocity Clinical Research
Sioux City, Iowa, United States
Johnson County Clin-Trials, Inc (JCCT)
Lenexa, Kansas, United States
...and 24 more locations