A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1468 in Healthy Adults ≥50 Years of Age
NCT ID: NCT05701800
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
659 participants
INTERVENTIONAL
2023-01-23
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Learn About a Modified RNA Vaccine Against Shingles in Healthy Adults
NCT05703607
A First-in-Human Study to Evaluate JCXH-105, an SrRNA-based Herpes Zoster Vaccine
NCT05871541
A Study to Evaluate Safety and Tolerability of a Recombinant Herpes Zoster Vaccine
NCT05750017
Clinical Trial to Evaluate EuHZV in Healthy Adults Aged 50 to 69 Years
NCT06409494
A Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants
NCT06375512
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part 1: mRNA-1468: Dose 1
Participants will receive placebo by intramuscular (IM) injection on Day 1 followed with mRNA-1468 by IM injection on Day 57 in Part 1.
mRNA-1468
Sterile liquid dispersion for injection
Placebo
Sterile liquid for injection
Part 1: mRNA-1468: Dose 2
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1.
mRNA-1468
Sterile liquid dispersion for injection
Part 1: mRNA-1468: Dose 3
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1.
mRNA-1468
Sterile liquid dispersion for injection
Part 1: mRNA-1468: Dose 4
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1.
mRNA-1468
Sterile liquid dispersion for injection
Part 1: Shingrix
Participants will receive Shingrix by IM injection on Day 1 and Day 57 in Part 1.
Shingrix
Sterile suspension for injection
Part 2: mRNA-1468: Dose 5
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 2.
mRNA-1468
Sterile liquid dispersion for injection
Part 2: mRNA-1468: Dose 6
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 2.
mRNA-1468
Sterile liquid dispersion for injection
Part 2: Shingrix
Participants will receive Shingrix by IM injection on Day 1 and Day 57 in Part 2.
Shingrix
Sterile suspension for injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
mRNA-1468
Sterile liquid dispersion for injection
Placebo
Sterile liquid for injection
Shingrix
Sterile suspension for injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Has a body mass index of 18 to \<40 kilograms/meter squared at the Screening Visit.
* Females of childbearing potential: have a negative pregnancy test at the Screening Visit and on the day of the first vaccination (Day 1); have practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1; have agreed to continue adequate contraception through 3 months following vaccine administration; are not currently breastfeeding.
Exclusion Criteria
* Has been previously vaccinated against varicella or HZ.
* Is acutely ill or febrile
* Body temperature ≥38.0°Celsius/100.4°Fahrenheit 72 hours prior to or at the Screening Visit or on Day 1. Participants meeting this criterion may be rescheduled within the allowed window.
* Has a current or previous diagnosis of congenital or acquired immunodeficiency, immunocompromizing/immunosuppressive condition, asplenia, or recurrent severe infections. Certain immune-mediated conditions that are well controlled and stable (for example, Hashimoto thyroiditis) as well as those that do not require systemic immunosuppressive therapy (for example, asthma, psoriasis, or vitiligo) may be permitted at the discretion of the Investigator.
* Has a dermatologic condition that could affect local solicited adverse reaction assessments (for example, tattoos, psoriasis patches affecting skin over the deltoid areas).
* Has any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
* Has a history of myocarditis, pericarditis, or myopericarditis.
* Has a reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA vaccine(s) or any components of the mRNA vaccines.
* Has received systemic immunosuppressants for \>14 days in total within 180 days prior to Screening Visit (for corticosteroids ≥10 milligrams/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled, nasal, intra-articular and topical steroids are allowed.
* Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, Infliximab) or blood products within 90 days prior to the Screening Visit or plans to receive them during the study.
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ModernaTX, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Velocity Clinical Research - Westlake
Los Angeles, California, United States
Tekton Research, Inc - Longmont Center
Longmont, Colorado, United States
Meridien Research
Lakeland, Florida, United States
Clinical Trials of Florida, LLC
Miami, Florida, United States
Floridian Clinical Research
Miami Lakes, Florida, United States
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, United States
Centricity Research
Columbus, Georgia, United States
Great Lakes
Chicago, Illinois, United States
DM Clinical Research- River Forest
River Forest, Illinois, United States
Meridian Clinical Research - Dakota Dunes
Sioux City, Iowa, United States
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas, United States
NOLA Research Works
New Orleans, Louisiana, United States
Velocity Clinical Research - Medford
Medford, Oregon, United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, United States
Tekton Research
Austin, Texas, United States
Gadolin Research
Beaumont, Texas, United States
LinQ Research, LLC
Houston, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Research Works San Juan
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
mRNA-1468-P101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.