At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 40,817 enrolled
Drug / intervention
mRNA-1010 +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Observer-blind, Active-controlled, Case-driven Study to Investigate the Safety, Efficacy, and Immunogenicity of mRNA-1010 Candidate Seasonal Influenza Vaccine Compared With a Licensed Inactivated Seasonal Influenza Vaccine in Adults ≥50 Years of Age
In Brief
A Phase 3 clinical trial evaluating mRNA-1010, Fluarix®, and 3 other interventions for Seasonal Influenza. Completed, enrolled 40,817 participants across 301 sites in 11 countries.
Detailed Summary
The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1010, and to evaluate relative vaccine efficacy (rVE) of mRNA-1010 versus an active comparator against reverse transcription polymerase chain reaction (RT-PCR)-confirmed protocol-defined influenza-like illness (ILI) caused by any influenza A or B strains.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeasonal Influenza
CountriesBelgium, Bulgaria, Canada, Estonia, Finland, Georgia, Germany, South Korea, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20252026
Enrollment StartSep 2024
First PostedSep 2024
Primary CompletionAug 2025
TodayJul 2026
First PostedSep 19, 2024
Enrollment StartSep 16, 2024
Primary CompletionAug 21, 2025
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 1.8 years ago
Interventions
mRNA-1010biological
Intramuscular (IM) injection
Fluarix®biological
IM injection
Influsplit® Tetrabiological
IM injection
Fluarix Tetrabiological
IM injection
Alpharix® Tetrabiological
IM injection