mRNA-1647
BiologicalSterile liquid for injection
NCT Number: NCT05575492
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.
Looking for future studies?
Notify Me9 year–25 year
All sexes
Interventional
Phase 1 / Phase 2
M.A.G.I.C. Clinic Ltd. Metabolics and Genetics in Calgary, Calgary, Alberta, Canada
The study will be conducted in 2 parts: Part 1 Dose-Ranging and Part 2 Safety Expansion.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
Sterile liquid for injection
0.9% sodium chloride injection (normal saline)
Time frame: Up to Day 176 (7 days after each study injection)
Time frame: Up to Day 197 (28 days after each study injection)
Time frame: Up to Day 347 (6 months after the last study injection)
Time frame: Up to Day 527 (end of study)
Time frame: Up to Day 527 (end of study)
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)
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)
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)
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)
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)
Serum antigen-specific binding antibody concentrations against vaccine antigens will be measured by ELISA specific to the gB and pentamer proteins.
ModernaTX, Inc.
Industry
A Phase 1/2a Open-Label Dose-Ranging and Observer-Blind Placebo-Controlled, Safety and Immunogenicity Study of mRNA-1647 Cytomegalovirus Vaccine in Female and Male Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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