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NCT05827926 · ClinicalTrials.gov registry record · Phase 1

A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults

A Phase 1 study of Influenza and SARS-CoV-2, sponsored by ModernaTX.

Completed
Registry status
Phase 1
Development phase
1,758
Enrollment target
20
Study locations

NCT05827926: Completed Phase 1 study of Influenza and SARS-CoV-2, sponsored by ModernaTX.

NCT05827926 is a Phase 1 study of Influenza and SARS-CoV-2 that has completed, run by ModernaTX. The registered enrollment target is 1,758 participants, below the 36,793-participant average among 156 other Influenza trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05827926, a Phase 1 study of Influenza and SARS-CoV-2, has completed, sponsored by ModernaTX.

COMPLETED
Registry status
Phase 1
Development phase
1,758 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Solicited ARs (local and systemic) were reported by participants an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills.

Conditions Studied

Influenza SARS-CoV-2

Interventions

  • BIOLOGICAL Influenza Vaccine 1
  • BIOLOGICAL mRNA-1083.1
  • BIOLOGICAL mRNA-1083.2
  • BIOLOGICAL mRNA-1083.3
  • BIOLOGICAL Investigational Influenza Vaccine 1

Study Locations (20)

Florida

  • Accel Research Sites - DeLand
  • CenExel - Hollywood
  • Nature Coast Clinical Research - Inverness
  • Jacksonville Center For Clinical Research - Jacksonville
  • Accel Research Sites - Maitland
  • Suncoast Research Group - Miami

California

  • Benchmark Research - Colton
  • Marvel Clinical Research - Huntington Beach
  • Central Valley Research - Modesto
  • Benchmark Research - Sacramento

Georgia

  • Centricity Research - Columbus
  • Accel Research Site - Decatur
  • CenExel iResearch - Decatur
  • Lifeline Primary Care - Lilburn

Illinois

  • Koch Family Medicine - Morton
  • Optimal Research - Peoria
  • DM Clinical Research - River Forest

Arizona

  • Chandler Clinical Trials - Chandler

Colorado

  • Tekton Research - Longmont

Kansas

  • Johnson County Clin-Trials - Lenexa

Trial Details

FieldValue
Enrollment Target 1,758 participants
Start Date 2023-04-14
Est. Completion 2024-12-03
Phase Phase 1
ModernaTX

90 total trials

What the finished NCT05827926 record still lists

NCT05827926 is an interventional study that assigns participants to a tested intervention. Its 1,758 participants enrollment target places it among the larger protocols in the corpus, below the 36,793-participant average among 156 other Influenza trials with a reported enrollment target (95% lower).

The record links to 2 conditions, with Influenza appearing as the primary indexed condition, and to 5 interventions - of which Influenza Vaccine 1 is the first listed.

NCT05827926 names 20 study sites across 7 states, led by Florida, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT05827926 about?

NCT05827926 is a clinical study titled "A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults". 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. Th...

What is the current status of trial NCT05827926?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 1,758 participants. The study started on 2023-04-14. Estimated completion is 2024-12-03.

What conditions does trial NCT05827926 study?

This clinical trial studies the following conditions: Influenza, SARS-CoV-2.

What interventions are being tested in trial NCT05827926?

The interventions under investigation include: Influenza Vaccine 1 (BIOLOGICAL), mRNA-1083.1 (BIOLOGICAL), mRNA-1083.2 (BIOLOGICAL), mRNA-1083.3 (BIOLOGICAL), Investigational Influenza Vaccine 1 (BIOLOGICAL).

Who is sponsoring clinical trial NCT05827926?

This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05827926 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Influenza

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05827926's enrollment target sits among peer trials

1,758 26th of 156 higher than 131 of 156 other Influenza trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Influenza trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05827926, the US trial registry maintained by the National Library of Medicine. NCT05827926 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.