CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 8,061 enrolled
Drug / intervention
mRNA-1083 +3 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.

Search/NCT06097273
NCT06097273Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

ModernaTX, Inc.·interventional·Posted Oct 24, 2023·Updated Jul 1, 2025

In Brief

A Phase 3 clinical trial evaluating mRNA-1083, Placebo, and 2 other interventions for SARS-CoV-2 and Influenza. Completed, enrolled 8,061 participants across 146 sites.

Detailed Summary

The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1083 as compared with active control, co-administered licensed influenza and severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) vaccines, in 2 independent age-group sub-study cohorts, healthy adults 65 years and older (Cohort A) and healthy adults 50 to \<65 years of age (Cohort B).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSARS-CoV-2, Influenza
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202420252026
First PostedOct 24, 2023
Enrollment StartOct 19, 2023
Primary CompletionMay 28, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 2.7 years ago

Interventions

mRNA-1083biological

Suspension for injection

Placebobiological

0.9% sodium chloride suspension for injection

Influenza Vaccinebiological

Commercially available formulation (Suspension for injection \[pre-filled syringe\])

COVID-19 Vaccinebiological

Commercially available formulation (Suspension for injection)