A Phase 3, Randomized, Observer-blind, Placebo-controlled Study to Evaluate the Immunogenicity, Safety, and Reactogenicity of mRNA-1018-H5 Pandemic Influenza Vaccine in Adults ≥18 Years of Age
ModernaTX, Inc.
Summary
The purpose of this study is to evaluate humoral immunogenicity after 2 doses of mRNA-1018-H5, and to evaluate the safety and reactogenicity of mRNA-1018-H5 in adults ≥18 years of age.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Key Inclusion Criteria: * Healthy as determined by medical evaluation including medical history; and physical examination. Participants with clinically stable chronic medical conditions are permitted. * Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast/chest feeding, and one of the following conditions applies: * Is a person of nonchildbearing potential (PONCBP) OR * Is a person of childbearing potential (POCBP) * A POCBP must have a negative highly sensitive pregnancy test at Screening and on…
Interventions
- BiologicalmRNA-1018-H5
Sterile liquid for injection.
- BiologicalPlacebo
Sterile liquid for injection.
Locations (36)
- Velocity Clinical Research, San BernardinoSan Bernardino, California
- Velocity Clinical Research, SavannahSavannah, Georgia
- Velocity Clinical Research, BoiseMeridian, Idaho
- Velocity Clinical Research, RockvilleRockville, Maryland
- Velocity Clinical Research, OmahaOmaha, Nebraska
- Velocity Clinical Research, ClevelandBeachwood, Ohio