Chandler Clinical Trials | Chandler, AZ
Status and phase
Conditions
Treatments
About
The study is divided into 2 parts: Part 1 and Part 2. The purpose of Part 1 of this study is to generate sufficient safety, reactogenicity, and immunogenicity data to enable selection of an mRNA-1083 vaccine composition and dose level to evaluate in a subsequent Phase 3 clinical trial in adults.
The purpose of Part 2 of this study is to generate safety and immunogenicity data for additional mRNA-1083 compositions and dose levels in young adults ≥18 years and <50 years of age.
Full description
Part 1: Participants will be enrolled into 1 of 2 age cohorts: Cohort A for adults ≥65 to <80 years of age or Cohort B for adults ≥18 to <65 year of age. In Cohort A, approximately 600 participants will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by influenza vaccine status in the most recent influenza season (received or not received since September 2022). In Cohort B, approximately 624 participants will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by 2 age groups: ≥18 to <50 years and ≥50 to <65 years of age and by influenza vaccine status in the most recent influenza season (received or not received since September 2022).
Part 2: Approximately, 520 participants between ≥18 to <50 years of age will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by influenza vaccine status in the most recent influenza season (received or not received since Sept 2023).
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Part 1 (Phase 1/2)
Part 2 (Phase 2 Extension)
Key Exclusion Criteria:
Part 1 (Phase 1/2) and Part 2 (Phase 2 Extension)
Part 2 (Phase 2 Extension) Only
Note: Other inclusion/exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
1,763 participants in 37 patient groups
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Central trial contact
Moderna Clinical Trials Support Center
Data sourced from clinicaltrials.gov
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