COMPLETED

A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the immunogenicity, reactogenicity, and safety, of mRNA-1083 multicomponent influenza and COVID-19 vaccine in adults ≥18 to \<65 years of age.

Official Title

A Phase 2, Randomized, Observer-blind, Active-control Study to Evaluate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age

Quick Facts

Study Start:2025-03-07
Study Completion:2025-10-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06864143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Medically stable.
  2. * Participants who could become pregnant: negative pregnancy test and contraception for at least 28 days prior to Day 1 and for at least 90 days after the study intervention administration.
  3. * Have received ≥2 coronavirus disease 2019 (COVID-19) vaccines, with the last COVID-19 vaccine administered \>150 days prior to Day 1.
  1. * History of a diagnosis or condition that is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
  2. * Tested positive for influenza by local health authority-approved testing methods within 150 days prior to Day 1.
  3. * History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 150 days prior to Day 1.
  4. * Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (eg, infliximab), within 180 days prior to Day 1 or plans to do so during the study.
  5. * Received or plans to receive any vaccine authorized or approved by a local health agency within 28 days prior to Day 1 or plans to do so within 28 days post study injection.
  6. * Received a licensed seasonal influenza vaccine within 150 days prior to Day 1.
  7. * Received a licensed/authorized COVID-19 vaccine within 150 days prior to Day 1.
  8. * Received any investigational influenza vaccine, investigational COVID-19 vaccine, or investigational combination vaccine for influenza and COVID-19 within 12 months prior to Day 1.
  9. * Participated in a clinical study with investigational treatment within 90 days prior to Day 1 (Baseline).

Contacts and Locations

Study Locations (Sites)

Headlands Research Scottsdale
Scottsdale, Arizona, 85260
United States
Artemis Research (Headlands)
San Diego, California, 92103
United States
Clinical Research Atlanta (Headlands)
Stockbridge, Georgia, 30281
United States
Velocity Clinical Research, Boise
Meridian, Idaho, 83642
United States
DM Clinical Research - Chicago
Melrose Park, Illinois, 60160
United States
Velocity Clinical Research, Lafayette
Lafayette, Louisiana, 70809
United States
Velocity Clinical Research, Rockville
Rockville, Maryland, 20854
United States
DM Clinical Research - Boston
Brookline, Massachusetts, 02446
United States
DM Clinical Research - Detroit
Southfield, Michigan, 48076
United States
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, 68701
United States
Trial Management Associates, LLC
Wilmington, North Carolina, 28403
United States
Velocity Clinical Research, Cincinnati, Mt. Auburn
Cincinnati, Ohio, 45219
United States
Velocity Clinical Research, Cincinnati, Springdale
Cincinnati, Ohio, 45246
United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, 19107
United States
Trial Management Associates, LLC
Myrtle Beach, South Carolina, 29572
United States
DM Clinical Research - Bellaire
Houston, Texas, 77081
United States
DM Clinical Research - Tomball
Tomball, Texas, 77375
United States

Collaborators and Investigators

Sponsor: ModernaTX, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-07
Study Completion Date2025-10-13

Study Record Updates

Study Start Date2025-03-07
Study Completion Date2025-10-13

Terms related to this study

Keywords Provided by Researchers

  • Influenza
  • SARS-CoV-2
  • mRNA-1083
  • COVID-19
  • Messenger RNA
  • Moderna

Additional Relevant MeSH Terms

  • Influenza
  • SARS-CoV-2