The main purpose of study is to evaluate the safety and immunogenicity of different dose levels of mRNA-1647 versus control in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive female and male participants 9 to 15 years of age. In addition, mRNA-1647 will be evaluated in female participants 16 to 25 years as a comparator cohort.
The study will be conducted in 2 parts: Part 1 Dose-Ranging and Part 2 Safety Expansion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
873
Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time frame: Up to Day 176 (7 days after each study injection)
Number of Unsolicited Adverse Events (AEs)
Time frame: Up to Day 197 (28 days after each study injection)
Number of Medically Attended Adverse Events (MAAEs)
Time frame: Up to Day 347 (6 months after the last study injection)
Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation
Time frame: Up to Day 527 (end of study)
Geometric Mean Titer (GMT) of Anti-CMV Neutralizing Antibodies (nAbs)
Serum functional antibody levels against vaccine antigens will be measured by nAb titer against epithelial cell infection and nAb titer against fibroblast infection.
Time frame: Up to Day 527 (end of study)
Geometric Mean Fold-Rise (GMFR) of Anti-CMV nAbs
Serum functional antibody levels against vaccine antigens will be measured by nAb titer against epithelial cell infection and nAb titer against fibroblast infection.
Time frame: Up to Day 527 (end of study)
Number of Participants with ≥2-Fold, 3-Fold, and 4-Fold increases Over Baseline of Anti-CMV Antibodies
Serum functional antibody levels against vaccine antigens will be measured by nAb titer against epithelial cell infection and nAb titer against fibroblast infection.
Time frame: Up to Day 527 (end of study)
Geometric Mean Concentration (GMC) of Binding Anti-Glycoprotein B (gB) Specific Immunoglobulin G (IgG) and Anti-Pentamer Specific IgG
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Serum antigen-specific binding antibody titers against vaccine antigens will be measured by enzyme-linked immunosorbent assay (ELISA) specific to the gB and pentamer proteins.
Time frame: Up to Day 527 (end of study)
Number of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases Over Baseline of Binding Anti-gB and Anti-pentamer Specific IgG
Serum antigen-specific binding antibody titers against vaccine antigens will be measured by ELISA specific to the gB and pentamer proteins.
Time frame: Up to Day 527 (end of study)
GMFR of Binding Anti-gB and Anti-pentamer Specific IgG
Serum antigen-specific binding antibody concentrations against vaccine antigens will be measured by ELISA specific to the gB and pentamer proteins.
Time frame: Up to Day 527 (end of study)