mRNA-1083 Composition 1 Dose A Lot A
BiologicalSterile liquid for injection
NCT Number: NCT06864143
The purpose of this study is to evaluate the immunogenicity, reactogenicity, and safety, of mRNA-1083 multicomponent influenza and COVID-19 vaccine in adults ≥18 to <65 years of age.
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Notify Me18 year–64 year
All sexes
Interventional
Phase 2
Headlands Research Scottsdale, Scottsdale, Arizona, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply.
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Time frame: Day 29
Time frame: Day 29
Time frame: Day 1 through 7 days after study injection
Time frame: Day 1 through 28 days after study injection
Time frame: Day 1 through Day 181
Time frame: Baseline (Day 1), Day 29
Time frame: Baseline (Day 1), Day 29
Time frame: Baseline (Day 1) to Day 29
Seroconversion is defined as postinjection level ≥1:40 if baseline is <1:10 or at least a 4-fold rise if baseline is ≥1:10 in HAI antibody titer.
Time frame: Baseline (Day 1) to Day 29
Seroresponse is defined as PsVNA concentration change from preinjection baseline below the lower limit of quantification (LLOQ) to postinjection ≥4×LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ.
ModernaTX, Inc.
Industry
A Phase 2, Randomized, Observer-blind, Active-control Study to Evaluate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 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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