mRNA-1647
BiologicalLyophilized product that is reconstituted with saline
NCT Number: NCT05105048
The main objective of this study is to evaluate the safety, reactogenicity, and immunogenicity of the mRNA-1647 vaccine administered according to a 3-study injection schedule in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive Japanese adults 18 to 40 years of age in the United States.
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Notify Me18 year–40 year
All sexes
Interventional
Phase 1
Velocity Clinical Research, North Hollywood, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
i. Any COVID-19 vaccination series must have been completed a minimum of 28 days prior to receiving any dose of the study injection.
ii. COVID-19 vaccines (regardless of manufacturer) must be administered at least 28 days prior to or after any study injection.
iii. Influenza vaccines may be administered >14 days prior to or after any study injection.
Other inclusion and exclusion criteria may apply.
Lyophilized product that is reconstituted with saline
0.9% sodium chloride (normal saline) injection
Time frame: Up to Day 176 (7 days after each injection)
Time frame: Up to Day 197 (28 days after each injection)
Time frame: Day 1 through 6 months after the last injection (up to Day 347)
Time frame: Day 1 through End of Study (EOS) (up to Day 347)
Time frame: Day 1 through EOS (up to Day 347)
Time frame: Days 1, 29, 85, 169, 197, and 347
Time frame: Days 29, 85, 169, 197, and 347
Time frame: Days 29, 85, 169, 197, and 347
Time frame: Days 1, 29, 85, 169, 197, and 347
Time frame: Days 29, 85, 169, 197, and 347
Time frame: Days 29, 85, 169, 197, and 347
ModernaTX, Inc.
Industry
A Phase 1, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccine mRNA-1647 When Administered to Healthy Japanese Adults (18-40 Years of Age) in the United States
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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