Phase
Condition
Shingles
Chickenpox (Varicella Zoster Infection)
Herpes Simplex Infections
Treatment
Placebo
mRNA-1468
Shingrix
Clinical Study ID
Ages > 50 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Part 1: Is an adult 50 years of age or older at the time of consent. Part 2: Is anadult 50-69 years of age at the time of consent.
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 ScreeningVisit and on the day of the first vaccination (Day 1); have practiced adequatecontraception or has abstained from all activities that could result in pregnancyfor at least 28 days prior to Day 1; have agreed to continue adequate contraceptionthrough 3 months following vaccine administration; are not currently breastfeeding.
Exclusion
Exclusion Criteria:
Has a history of HZ within the past 10 years.
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 theScreening Visit or on Day 1. Participants meeting this criterion may be rescheduledwithin the allowed window.
Has a current or previous diagnosis of congenital or acquired immunodeficiency,immunocompromizing/immunosuppressive condition, asplenia, or recurrent severeinfections. Certain immune-mediated conditions that are well controlled and stable (for example, Hashimoto thyroiditis) as well as those that do not require systemicimmunosuppressive therapy (for example, asthma, psoriasis, or vitiligo) may bepermitted at the discretion of the Investigator.
Has a dermatologic condition that could affect local solicited adverse reactionassessments (for example, tattoos, psoriasis patches affecting skin over the deltoidareas).
Has any medical, psychiatric, or occupational condition, including reported historyof substance abuse, that, in the opinion of the Investigator, might pose additionalrisk due to participation in the study or could interfere with the interpretation ofstudy results.
Has a history of myocarditis, pericarditis, or myopericarditis.
Has a reported history of anaphylaxis or severe hypersensitivity reaction afterreceipt of any mRNA vaccine(s) or any components of the mRNA vaccines.
Has received systemic immunosuppressants for >14 days in total within 180 days priorto Screening Visit (for corticosteroids ≥10 milligrams/day of prednisone orequivalent) or is anticipating the need for systemic immunosuppressive treatment atany time during participation in the study. Inhaled, nasal, intra-articular andtopical steroids are allowed.
Has received systemic immunoglobulins, long-acting biological therapies that affectimmune responses (for example, Infliximab) or blood products within 90 days prior tothe Screening Visit or plans to receive them during the study.
Other protocol-defined inclusion/exclusion criteria apply.
Study Design
Connect with a study center
Research Works San Juan
San Juan, 00907
Puerto RicoSite Not Available
Velocity Clinical Research - Westlake
Los Angeles, California 90057
United StatesSite Not Available
Tekton Research, Inc - Longmont Center
Longmont, Colorado 80501
United StatesSite Not Available
Meridien Research
Lakeland, Florida 33805
United StatesSite Not Available
Clinical Trials of Florida, LLC
Miami, Florida 33186
United StatesSite Not Available
Floridian Clinical Research
Miami Lakes, Florida 33016
United StatesSite Not Available
Florida Pulmonary Research Institute, LLC
Winter Park, Florida 32789
United StatesSite Not Available
Centricity Research
Columbus, Georgia 31904
United StatesSite Not Available
Great Lakes
Chicago, Illinois 60640
United StatesSite Not Available
DM Clinical Research- River Forest
River Forest, Illinois 60305
United StatesSite Not Available
Meridian Clinical Research - Dakota Dunes
Sioux City, Iowa 51106
United StatesSite Not Available
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas 66219
United StatesSite Not Available
NOLA Research Works
New Orleans, Louisiana 70115
United StatesSite Not Available
Velocity Clinical Research - Medford
Medford, Oregon 97504
United StatesSite Not Available
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
WR-ClinSearch, LLC
Chattanooga, Tennessee 37421
United StatesSite Not Available
Tekton Research
Austin, Texas 78745
United StatesSite Not Available
Gadolin Research
Beaumont, Texas 77702
United StatesSite Not Available
LinQ Research, LLC
Houston, Texas 77087
United StatesSite Not Available
DM Clinical Research
Tomball, Texas 77375
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.