Phase
Condition
Hiv
Treatment
Placebo
mRNA-1647
Clinical Study ID
Ages 9-25 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Is a female or male 9 to 15 years of age or is a female 16 to 25 years of age at thetime of consent.
Is in good general health, in the opinion of the Investigator, and is capable ofcomplying with study procedures.
For the CMV-seronegative cohorts: At the Screening visit, is CMV IgG-negative andCMV immunoglobulin M (IgM)-negative.
For CMV-seropositive cohorts: At the Screening visit, is CMV IgG-positive and CMVIgM-negative, CMV IgG-positive and CMV IgM-positive, or CMV IgG-positive and CMVIgM-indeterminate. Participants with an isolated positive or indeterminate resultfor CMV IgM (that is, CMV IgG-negative and either CMV IgM-positive or CMVIgM-indeterminate) will not be eligible for enrollment but may be rescreened afterat least 6 weeks from the initial CMV Screening. Participants with an indeterminateresult for CMV IgG, regardless of IgM result, will not be eligible for enrollmentbut may be rescreened after at least 6 weeks from the initial CMV screening.
If 9 to 15 years of age, has a body mass index (BMI) at or above the thirdpercentile according to World Health Organization (WHO) Child Growth Standards. If 16 to 25 years of age: has a BMI of 15 to 35 kilograms (kg)/square meter (m^2).
For female participants of childbearing potential: negative pregnancy test, adequatecontraception or has abstained from all activities that could result in pregnancyfor at least 28 days prior to Day 1, agreement to continue adequate contraceptionthrough 3 months following vaccine administration.
Exclusion
Key Exclusion Criteria:
Has a history of a diagnosis or condition that, in the judgment of Investigator, isclinically unstable or may affect participant safety, assessment of safetyendpoints, assessment of immune response, or adherence to study procedures.Clinically unstable is defined as diagnosis or condition requiring significantchanges in management or medication within the 2 months prior to Screening andincludes ongoing workup of an undiagnosed illness that could lead to a new diagnosisor condition.
Has received, or plans to receive, any nonstudy vaccine < 28 days prior to or afterany study injection.
Has a screening liver function test (aspartate aminotransferase, alanineaminotransferase, total bilirubin) or a screening creatinine result of ToxicityGrade ≥1.
Has a Screening hematology or coagulation result of Toxicity Grade ≥1.
Is acutely ill or febrile (body temperature ≥38.0 degrees Celsius [°C]/100.4 degreesFahrenheit [°F]) at the Screening Visit.
Has received systemic immunosuppressants or immune-modifying drugs for > 14 days intotal within 6 months prior to the day of enrollment (for corticosteroids, ≥1milligrams (mg)/kg/day or ≥10 mg/day prednisone equivalent).
Has received an antiviral with activity against CMV (ganciclovir, valganciclovir,foscarnet, cidofovir, letermovir, acyclovir, valacyclovir) <2 weeks prior to the dayof the first study injection (Day 1) or plans to do so during the course of thestudy.
Reports a history of myocarditis, pericarditis, or myopericarditis.
Has reported medical history of hepatitis B, hepatitis C, or human immunodeficiencyvirus (HIV); or a positive screening test for hepatitis B surface antigen (HBsAg),hepatitis C antibodies, or HIV 1 or 2 antibodies.
Has previously received an investigational CMV vaccine.
Has received systemic immunoglobulins or blood products <3 months prior to the dayof the first study injection (Day 1).
Has donated ≥ 450 milliliter (mL) of blood products <28 days prior to the day of thefirst study injection (Day 1).
Has participated in an interventional clinical study <28 days prior to the day ofthe first study injection (Day 1) or plans to do so while enrolled in the study.
Note: Other inclusion and exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
M.A.G.I.C. Clinic Ltd. Metabolics and Genetics in Calgary
Calgary, Alberta
CanadaActive - Recruiting
ALTA Clinical Research Inc
Edmonton, Alberta
CanadaActive - Recruiting
CARe Clinic
Red Deer, Alberta
CanadaActive - Recruiting
Canadian Center for Vaccinology
Halifax, Nova Scotia
CanadaActive - Recruiting
Hamilton Medical Research Group
Hamilton, Ontario
CanadaSite Not Available
Bluewater Clinical Research Group
Sarnia, Ontario
CanadaSite Not Available
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec
CanadaActive - Recruiting
Medicentres Canada Incorporated
Edmonton,
CanadaActive - Recruiting
Addenbrooke's Hospital
Cambridge, Cambridgeshire
United KingdomSite Not Available
Southampton General Hospital
Southampton, Hampshire
United KingdomActive - Recruiting
Manchester Royal Infirmary - PPDS
Manchester, Lancashire
United KingdomActive - Recruiting
Lakeside Healthcare
Corby, Northamptonshire
United KingdomActive - Recruiting
Sheffield Children's Hospital
Sheffield, South Yorkshire
United KingdomActive - Recruiting
Queen Elizabeth Hospital
Birmingham,
United KingdomSite Not Available
Noah's Ark Children's Hospital for Wales
Cardiff,
United KingdomActive - Recruiting
St. George Hospital
London,
United KingdomActive - Recruiting
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesActive - Recruiting
Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
La Mesa, California 91942-3189
United StatesActive - Recruiting
Velocity Clinical Research - San Diego - PPDS
La Mesa, California 91942
United StatesActive - Recruiting
Benchmark Research - Sacramento -Hypercore- PPDS
Sacramento, California 95864
United StatesActive - Recruiting
Tekton Research - Fort Collins - Platinum - PPDS
Fort Collins, Colorado 80525-5752
United StatesActive - Recruiting
Meridian Clinical Research, LLC - Washington - Platinum - PPDS
Washington, District of Columbia 20016
United StatesSite Not Available
Velocity Clinical Research (Washington)- PPDS
Washington, District of Columbia 20016
United StatesActive - Recruiting
Prohealth Research Center
Doral, Florida 33166-6613
United StatesActive - Recruiting
Clinical Neuroscience Solutions Inc (Jacksonville-Belfort Rd)
Jacksonville, Florida 32256-6040
United StatesActive - Recruiting
University of Florida Jacksonville
Jacksonville, Florida 32209
United StatesActive - Recruiting
Clinical Neurosciences Solutions Inc. (Orlando-East South St)
Orlando, Florida 32801-2987
United StatesActive - Recruiting
Palm Harbor Dermatology
Tampa, Florida 33609-2230
United StatesActive - Recruiting
Santos Research Center
Tampa, Florida 33615-3219
United StatesActive - Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia 30322-1014
United StatesActive - Recruiting
Tekton Research - Georgia - Platinum - PPDS
Chamblee, Georgia 30341
United StatesSite Not Available
Centricity Research Roswell
Columbus, Georgia 31904-8946
United StatesActive - Recruiting
IACT Health - Roswell - IACT - HyperCore - PPDS
Columbus, Georgia 31904-8946
United StatesSite Not Available
iResearch Atlanta - CenExel - PPDS
Decatur, Georgia 30030-3438
United StatesActive - Recruiting
Clinical Research Prime - ClinEdge - PPDS
Idaho Falls, Idaho 83404-5305
United StatesActive - Recruiting
Benchmark Research - Covington - HyperCore- PPDS
Covington, Louisiana 70433
United StatesActive - Recruiting
Tulane Medical Center
New Orleans, Louisiana 70112-2632
United StatesActive - Recruiting
University of Maryland School of Medicine
Baltimore, Maryland 21201-1509
United StatesActive - Recruiting
The Pediatric Centre
Columbia, Maryland 21045
United StatesActive - Recruiting
The Pediatric Centre of Frederick
Frederick, Maryland 21702
United StatesActive - Recruiting
Wayne State University
Detroit, Michigan 48201
United StatesActive - Recruiting
University of Minnesota
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
Velocity Clinical Research - Gulfport
Gulfport, Mississippi 39503
United StatesActive - Recruiting
Alliance for Multispecialty Research - Kansas City
Kansas City, Missouri 64114-4859
United StatesSite Not Available
Meridian Clinical Research (Omaha-Nebraska) - Platinum - PPDS
Lincoln, Nebraska 68510
United StatesSite Not Available
Velocity Clinical Research (Lincoln-Nebraska) - PPDS
Lincoln, Nebraska 68510
United StatesActive - Recruiting
Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDS
Norfolk, Nebraska 68701-7701
United StatesSite Not Available
Velocity Clinical Research (Norfolk - Nebraska) - PPDS
Norfolk, Nebraska 68701-7701
United StatesActive - Recruiting
Meridian Clinical Research (Omaha-Nebraska) - Platinum - PPDS
Omaha, Nebraska 68134-3664
United StatesSite Not Available
Velocity Clinical Research (Omaha-Nebraska) - Platinum - PPDS
Omaha, Nebraska 68134-3664
United StatesActive - Recruiting
Adekunle Adeoti LLC
East Orange, New Jersey 07018-2012
United StatesSite Not Available
Albuquerque Clinical Trials Inc - Clinedge - PPDS
Albuquerque, New Mexico 87102-2619
United StatesActive - Recruiting
MedPharmics, LLC. - Albuquerque - Platinum - PPDS
Albuquerque, New Mexico 87102-3644
United StatesSite Not Available
Velocity Clinical Research -Albuquerque -PPDS
Albuquerque, New Mexico 87102-3644
United StatesActive - Recruiting
Velocity Clinical Research (Binghamton - New York) - PPDS
Binghamton, New York 13901-1046
United StatesActive - Recruiting
Rochester Clinical Research, Inc
Rochester, New York 14609-3173
United StatesActive - Recruiting
Stony Brook University Medical Center
Stony Brook, New York 11794-0001
United StatesActive - Recruiting
Child Healthcare Associates - East Syracuse
Syracuse, New York 13210-2306
United StatesSite Not Available
OnSite Clinical Solutions, LLC - ClinEdge - PPDS
Charlotte, North Carolina 28277-4859
United StatesActive - Recruiting
Lucas Research - Morehead City - HyperCore - PPDS
Morehead City, North Carolina 28557-3126
United StatesSite Not Available
Tekton Research - Oklahoma- PPDS
Edmond, Oklahoma 73013
United StatesActive - Recruiting
Lynn Institute of Norman - ERN - PPDS
Norman, Oklahoma 73072-3251
United StatesActive - Recruiting
Velocity Clinical Research - Medford - PPDS
Medford, Oregon 97504-7738
United StatesActive - Recruiting
Coastal Carolina Research Center - PPDS
North Charleston, South Carolina 29405
United StatesSite Not Available
Meharry Medical College
Nashville, Tennessee 37208
United StatesActive - Recruiting
Tekton Research - Texas - PPDS
Austin, Texas 78705
United StatesActive - Recruiting
Tekton Research - Beaumont - Platinum - PPDS
Beaumont, Texas 77706-3061
United StatesActive - Recruiting
3rd Coast Research Associates
Corpus Christi, Texas 78414-4106
United StatesSite Not Available
South Texas Clinical Research
Corpus Christi, Texas 78404
United StatesSite Not Available
BRCR Global Texas
Edinburg, Texas 78539
United StatesSite Not Available
Benchmark Research - Fort Worth - HyperCore -PPDS
Fort Worth, Texas 76135
United StatesActive - Recruiting
University of Texas Medical Branch (UTMB)
Galveston, Texas 77550
United StatesActive - Recruiting
Baylor College of Medicine
Houston, Texas 77030-3411
United StatesSite Not Available
Biopharma Informatic, LLC
Houston, Texas 77043-2737
United StatesSite Not Available
Bipharma Informatic -Cardiff Avenue - PPDS
Houston, Texas 77084
United StatesSite Not Available
West Houston Clinical Research - Hunt - PPDS
Houston, Texas 77055-1626
United StatesActive - Recruiting
Victoria Clinical Research Group
Port Lavaca, Texas 77979
United StatesActive - Recruiting
Benchmark Research - San Angelo - HyperCore - PPDS
San Angelo, Texas 76904
United StatesActive - Recruiting
Tekton Research - Texas - Platinum - PPDS
San Antonio, Texas 78229
United StatesActive - Recruiting
DM Clinical Research - ERN- PPDS
Tomball, Texas 77375
United StatesActive - Recruiting
Crossroads Clinical Research (Victoria)
Victoria, Texas 77901
United StatesActive - Recruiting
JBR Clinical Research - CenExel JBR - PPDS
Salt Lake City, Utah 84107-4536
United StatesActive - Recruiting
Alliance for Multispecialty Research, LLC - Norfolk
Norfolk, Virginia 23502-3932
United StatesSite Not Available
MultiCare Institute for Research and Innovation
Spokane, Washington 99204-2803
United StatesActive - Recruiting
University Of Wisconsin - Madison
Madison, Wisconsin 53792-0001
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.