CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,758 enrolled
Drug / intervention
Influenza Vaccine 1 +11 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/NCT05827926
NCT05827926Phase 2Completed
CompareCT.gov

A Phase 1/2, Randomized, Observer-blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-based Influenza and SARS-CoV-2 Multi-component Vaccines in Healthy Adults

ModernaTX, Inc.·interventional·Posted Apr 25, 2023·Updated Dec 23, 2025

In Brief

A Phase 2 clinical trial evaluating Influenza Vaccine 1, mRNA-1083.1, and 10 other interventions for SARS-CoV-2 and Influenza. Completed, enrolled 1,758 participants across 69 sites.

Detailed Summary

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.

Study Details

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

Timeline

Phase 2CompletedFinished
202420252026
First PostedApr 25, 2023
Enrollment StartApr 14, 2023
Primary CompletionDec 3, 2024
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 3.2 years ago

Interventions

Influenza Vaccine 1biological

quadrivalent seasonal influenza vaccine

mRNA-1083.1biological

Sterile liquid for injection

mRNA-1083.2biological

Sterile liquid for injection

mRNA-1083.3biological

Sterile liquid for injection

Investigational Influenza Vaccine 1biological

Sterile liquid for injection

Investigational COVID-19 Vaccine 1biological

Sterile liquid for injection

COVID-19 Vaccine 1biological

Sterile liquid for injection

Investigational Influenza Vaccine 2biological

Sterile liquid for injection

Influenza Vaccine 2biological

quadrivalent seasonal influenza vaccine

mRNA-1083biological

Sterile liquid for injection

Investigational COVID-19 Vaccine 2biological

Sterile liquid for injection

COVID-19 Vaccine 2biological

Sterile liquid for injection