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 the CMV-seropositive cohorts: At the Screening visit, is CMV IgG-positive andCMV IgM-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
CanadaSite Not Available
ALTA Clinical Research Inc
Edmonton, Alberta
CanadaSite Not Available
CARe Clinic
Red Deer, Alberta
CanadaSite Not Available
M.A.G.I.C. Clinic Ltd. Metabolics and Genetics in Calgary
Calgary 5913490, Alberta 5883102
CanadaSite Not Available
ALTA Clinical Research Inc
Edmonton 5946768, Alberta 5883102
CanadaSite Not Available
CARe Clinic
Red Deer 6118158, Alberta 5883102
CanadaSite Not Available
Canadian Center for Vaccinology
Halifax, Nova Scotia
CanadaSite Not Available
Canadian Center for Vaccinology
Halifax 6324729, Nova Scotia 6091530
CanadaSite Not Available
Hamilton Medical Research Group
Hamilton, Ontario
CanadaSite Not Available
Bluewater Clinical Research Group
Sarnia, Ontario
CanadaSite Not Available
Hamilton Medical Research Group
Hamilton 5969782, Ontario 6093943
CanadaSite Not Available
Bluewater Clinical Research Group
Sarnia 6141190, Ontario 6093943
CanadaSite Not Available
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec
CanadaSite Not Available
Centre Hospitalier Universitaire Sainte-Justine
Montreal 6077243, Quebec 6115047
CanadaSite Not Available
Medicentres Canada Incorporated
Edmonton,
CanadaActive - Recruiting
Addenbrooke's Hospital
Cambridge, Cambridgeshire
United KingdomSite Not Available
Southampton General Hospital
Southampton, Hampshire
United KingdomSite Not Available
Southampton General Hospital
Southampton 2637487, Hampshire
United KingdomSite Not Available
Manchester Royal Infirmary - PPDS
Manchester, Lancashire
United KingdomSite Not Available
Lakeside Healthcare
Corby, Northamptonshire
United KingdomSite Not Available
Lakeside Healthcare
Corby 2652381, Northamptonshire
United KingdomSite Not Available
Sheffield Children's Hospital
Sheffield, South Yorkshire
United KingdomSite Not Available
Sheffield Children's Hospital
Sheffield 2638077, South Yorkshire
United KingdomSite Not Available
Queen Elizabeth Hospital
Birmingham,
United KingdomCompleted
Queen Elizabeth Hospital
Birmingham 2655603,
United KingdomSite Not Available
Noah's Ark Children's Hospital for Wales
Cardiff,
United KingdomSite Not Available
Noah's Ark Children's Hospital for Wales
Cardiff 2653822,
United KingdomSite Not Available
St. George Hospital
London,
United KingdomSite Not Available
St. George Hospital
London 2643743,
United KingdomSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
La Mesa, California 91942-3189
United StatesSite Not Available
Velocity Clinical Research - San Diego - PPDS
La Mesa, California 91942
United StatesActive - Recruiting
Benchmark Research - Sacramento -Hypercore- PPDS
Sacramento, California 95864
United StatesSite Not Available
Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
La Mesa 5363990, California 5332921 91942-3189
United StatesSite Not Available
Velocity Clinical Research - San Diego - PPDS
La Mesa 5363990, California 5332921 91942
United StatesSite Not Available
Benchmark Research - Sacramento -Hypercore- PPDS
Sacramento 5389489, California 5332921 95864
United StatesSite Not Available
Tekton Research - Fort Collins - Platinum - PPDS
Fort Collins, Colorado 80525-5752
United StatesSite Not Available
Tekton Research - Fort Collins - Platinum - PPDS
Fort Collins 5577147, Colorado 5417618 80525-5752
United StatesSite Not Available
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 StatesSite Not Available
Velocity Clinical Research (Washington)- PPDS
Washington D.C. 4140963, District of Columbia 4138106 20016
United StatesSite Not Available
Prohealth Research Center
Doral, Florida 33166-6613
United StatesSite Not Available
Clinical Neuroscience Solutions Inc (Jacksonville-Belfort Rd)
Jacksonville, Florida 32256-6040
United StatesActive - Recruiting
University of Florida Jacksonville
Jacksonville, Florida 32209
United StatesSite Not Available
Clinical Neurosciences Solutions Inc. (Orlando-East South St)
Orlando, Florida 32801-2987
United StatesSite Not Available
Palm Harbor Dermatology
Tampa, Florida 33609-2230
United StatesActive - Recruiting
Santos Research Center
Tampa, Florida 33615-3219
United StatesSite Not Available
Prohealth Research Center
Doral 4153471, Florida 4155751 33166-6613
United StatesSite Not Available
Clinical Neuroscience Solutions Inc (Jacksonville-Belfort Rd)
Jacksonville 4160021, Florida 4155751 32256-6040
United StatesSite Not Available
University of Florida Jacksonville
Jacksonville 4160021, Florida 4155751 32209
United StatesSite Not Available
Clinical Neurosciences Solutions Inc. (Orlando-East South St)
Orlando 4167147, Florida 4155751 32801-2987
United StatesSite Not Available
Palm Harbor Dermatology
Tampa 4174757, Florida 4155751 33609-2230
United StatesSite Not Available
Santos Research Center
Tampa 4174757, Florida 4155751 33615-3219
United StatesSite Not Available
Children's Healthcare of Atlanta
Atlanta, Georgia 30322-1014
United StatesSite Not Available
Tekton Research - Georgia - Platinum - PPDS
Chamblee, Georgia 30341
United StatesSite Not Available
Centricity Research Roswell
Columbus, Georgia 31904-8946
United StatesSite Not Available
IACT Health - Roswell - IACT - HyperCore - PPDS
Columbus, Georgia 31904-8946
United StatesSite Not Available
iResearch Atlanta - CenExel - PPDS
Decatur, Georgia 30030-3438
United StatesSite Not Available
Children's Healthcare of Atlanta
Atlanta 4180439, Georgia 4197000 30322-1014
United StatesSite Not Available
Centricity Research Roswell
Columbus 4188985, Georgia 4197000 31904-8946
United StatesSite Not Available
iResearch Atlanta - CenExel - PPDS
Decatur 4191124, Georgia 4197000 30030-3438
United StatesSite Not Available
Clinical Research Prime - ClinEdge - PPDS
Idaho Falls, Idaho 83404-5305
United StatesSite Not Available
Clinical Research Prime - ClinEdge - PPDS
Idaho Falls 5596475, Idaho 5596512 83404-5305
United StatesSite Not Available
Benchmark Research - Covington - HyperCore- PPDS
Covington, Louisiana 70433
United StatesSite Not Available
Tulane Medical Center
New Orleans, Louisiana 70112-2632
United StatesSite Not Available
Benchmark Research - Covington - HyperCore- PPDS
Covington 4321005, Louisiana 4331987 70433
United StatesSite Not Available
Tulane Medical Center
New Orleans 4335045, Louisiana 4331987 70112-2632
United StatesSite Not Available
University of Maryland School of Medicine
Baltimore, Maryland 21201-1509
United StatesSite Not Available
The Pediatric Centre
Columbia, Maryland 21045
United StatesSite Not Available
The Pediatric Centre of Frederick
Frederick, Maryland 21702
United StatesSite Not Available
University of Maryland School of Medicine
Baltimore 4347778, Maryland 4361885 21201-1509
United StatesSite Not Available
The Pediatric Centre
Columbia 4352053, Maryland 4361885 21045
United StatesSite Not Available
The Pediatric Centre of Frederick
Frederick 4355585, Maryland 4361885 21702
United StatesSite Not Available
Wayne State University
Detroit, Michigan 48201
United StatesSite Not Available
Wayne State University
Detroit 4990729, Michigan 5001836 48201
United StatesSite Not Available
University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55455
United StatesSite Not Available
Velocity Clinical Research - Gulfport
Gulfport, Mississippi 39503
United StatesSite Not Available
Velocity Clinical Research - Gulfport
Gulfport 4428667, Mississippi 4436296 39503
United StatesSite Not Available
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 StatesSite Not Available
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 StatesSite Not Available
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 StatesSite Not Available
Velocity Clinical Research (Lincoln-Nebraska) - PPDS
Lincoln 5072006, Nebraska 5073708 68510
United StatesSite Not Available
Velocity Clinical Research (Norfolk - Nebraska) - PPDS
Norfolk 5073965, Nebraska 5073708 68701-7701
United StatesSite Not Available
Velocity Clinical Research (Omaha-Nebraska) - Platinum - PPDS
Omaha 5074472, Nebraska 5073708 68134-3664
United StatesSite Not Available
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 StatesSite Not Available
Albuquerque Clinical Trials Inc - Clinedge - PPDS
Albuquerque 5454711, New Mexico 5481136 87102-2619
United StatesSite Not Available
Velocity Clinical Research -Albuquerque -PPDS
Albuquerque 5454711, New Mexico 5481136 87102-3644
United StatesSite Not Available
Velocity Clinical Research (Binghamton - New York) - PPDS
Binghamton, New York 13901-1046
United StatesSite Not Available
Rochester Clinical Research, Inc
Rochester, New York 14609-3173
United StatesSite Not Available
Stony Brook University Medical Center
Stony Brook, New York 11794-0001
United StatesSite Not Available
Child Healthcare Associates - East Syracuse
Syracuse, New York 13210-2306
United StatesSite Not Available
Velocity Clinical Research (Binghamton - New York) - PPDS
Binghamton 5109177, New York 5128638 13901-1046
United StatesSite Not Available
Rochester Clinical Research, Inc
Rochester 5134086, New York 5128638 14609-3173
United StatesSite Not Available
OnSite Clinical Solutions, LLC - ClinEdge - PPDS
Charlotte, North Carolina 28277-4859
United StatesSite Not Available
Lucas Research - Morehead City - HyperCore - PPDS
Morehead City, North Carolina 28557-3126
United StatesSite Not Available
OnSite Clinical Solutions, LLC - ClinEdge - PPDS
Charlotte 4460243, North Carolina 4482348 28277-4859
United StatesSite Not Available
Tekton Research - Oklahoma- PPDS
Edmond, Oklahoma 73013
United StatesSite Not Available
Lynn Institute of Norman - ERN - PPDS
Norman, Oklahoma 73072-3251
United StatesSite Not Available
Tekton Research - Oklahoma- PPDS
Edmond 4535740, Oklahoma 4544379 73013
United StatesSite Not Available
Lynn Institute of Norman - ERN - PPDS
Norman 4543762, Oklahoma 4544379 73072-3251
United StatesSite Not Available
Velocity Clinical Research - Medford - PPDS
Medford, Oregon 97504-7738
United StatesSite Not Available
Velocity Clinical Research - Medford - PPDS
Medford 5740099, Oregon 5744337 97504-7738
United StatesSite Not Available
Coastal Carolina Research Center - PPDS
North Charleston, South Carolina 29405
United StatesSite Not Available
Meharry Medical College
Nashville, Tennessee 37208
United StatesSite Not Available
Meharry Medical College
Nashville 4644585, Tennessee 4662168 37208
United StatesSite Not Available
Tekton Research - Texas - PPDS
Austin, Texas 78705
United StatesSite Not Available
Tekton Research - Beaumont - Platinum - PPDS
Beaumont, Texas 77706-3061
United StatesSite Not Available
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 StatesSite Not Available
University of Texas Medical Branch (UTMB)
Galveston, Texas 77550
United StatesSite Not Available
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 StatesSite Not Available
Benchmark Research - San Angelo - HyperCore - PPDS
San Angelo, Texas 76904
United StatesSite Not Available
Tekton Research - Texas - Platinum - PPDS
San Antonio, Texas 78229
United StatesSite Not Available
DM Clinical Research - ERN- PPDS
Tomball, Texas 77375
United StatesSite Not Available
Crossroads Clinical Research (Victoria)
Victoria, Texas 77901
United StatesSite Not Available
Tekton Research - Texas - PPDS
Austin 4671654, Texas 4736286 78705
United StatesSite Not Available
Tekton Research - Beaumont - Platinum - PPDS
Beaumont 4672989, Texas 4736286 77706-3061
United StatesSite Not Available
Benchmark Research - Fort Worth - HyperCore -PPDS
Fort Worth 4691930, Texas 4736286 76135
United StatesSite Not Available
University of Texas Medical Branch (UTMB)
Galveston 4692883, Texas 4736286 77550
United StatesSite Not Available
West Houston Clinical Research - Hunt - PPDS
Houston 4699066, Texas 4736286 77055-1626
United StatesSite Not Available
Victoria Clinical Research Group
Port Lavaca 4720067, Texas 4736286 77979
United StatesSite Not Available
Benchmark Research - San Angelo - HyperCore - PPDS
San Angelo 5530022, Texas 4736286 76904
United StatesSite Not Available
Tekton Research - Texas - Platinum - PPDS
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
DM Clinical Research - ERN- PPDS
Tomball 4737094, Texas 4736286 77375
United StatesSite Not Available
Crossroads Clinical Research (Victoria)
Victoria 4739157, Texas 4736286 77901
United StatesSite Not Available
JBR Clinical Research - CenExel JBR - PPDS
Salt Lake City, Utah 84107-4536
United StatesSite Not Available
JBR Clinical Research - CenExel JBR - PPDS
Salt Lake City 5780993, Utah 5549030 84107-4536
United StatesSite Not Available
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 StatesSite Not Available
MultiCare Institute for Research and Innovation
Spokane 5811696, Washington 5815135 99204-2803
United StatesSite Not Available
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.