Phase
Condition
Shingles
Throat And Tonsil Infections
Rash
Treatment
Investigational MMRV(H)NS vaccine
Marketed MMRV_Lot 1 and Lot 2 vaccine
Investigational M(L)M(L)R(L)V(L)NS vaccine
Clinical Study ID
Ages 4-6 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy participants as established by medical history and clinical examinationbefore entering into the study.
A male or female between, and including, 4 years and 6 years of age (i.e., from 4year birthday until the day before the 7-year birthday) at the time of studyintervention administration, and in accordance with local regulations.
Participant who previously received a first dose of varicella-containing vaccine inthe second year of life.
Participant who previously received a single dose of measles-, mumps-,rubella-containing vaccine in the second year of life.
Written informed consent obtained from the participants' parent(s)/legallyacceptable representative(s) (LAR[s]) prior to performance of any study-specificprocedure (participant informed assent will be obtained from participants in linewith local rules and regulations).
Participants' parent(s)/LAR(s), who, in the opinion of the investigator, can andwill comply with the requirements of the protocol (e.g., completion of electronicdiaries [eDiaries], return for follow-up visits).
Exclusion
Exclusion Criteria:
Medical Conditions
History of any reaction or hypersensitivity likely to be exacerbated by anycomponent of the study interventions including hypersensitivity to neomycin orgelatin.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based onmedical history and physical examination (no laboratory testing required).
Hypersensitivity to latex.
Major congenital defects, as assessed by the investigator.
History of measles, mumps, rubella, or varicella disease.
Recurrent history of or uncontrolled neurological disorders or seizures.
Acute disease at the time of enrollment. Acute disease is defined as the presence ofa moderate or severe illness with or without fever. Fever is defined as bodytemperature >=38.0 degrees Celsius (°C) (100.4 degrees Fahrenheit [°F)] by anyage-appropriate route. All study interventions can be administered to participantswith a minor illness such as diarrhea, mild upper respiratory infection withoutfever.
Participant with history of coronavirus disease 2019 (COVID-19) who is stillsymptomatic.
Any other clinical condition that, in the opinion of the investigator, might poseadditional risk to the participant due to participation in the study.
Prior and Concomitant Therapy
Use of any investigational or non-registered product (drug, vaccine, or medicaldevice) other than the study interventions during the period beginning 30 daysbefore the dose of study interventions (Day -29 to Day 1), or their planned useduring the study period.
Chronic administration (defined as more than 14 days in total) of immunosuppressantsor other immune-modifying drugs during the period starting 90 days prior to thestudy intervention administration. For corticosteroids, this will mean prednisoneequivalent >= 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatricparticipants. Inhaled and topical steroids are allowed.
Administration of immunoglobulins and/or any blood products or plasma derivativesduring the period starting 180 days before the dose of study interventions orplanned administration during the study period.
Administration of long-acting immune-modifying drugs at any time during the studyperiod (e.g., infliximab).
Previous vaccination with a second dose of varicella-containing vaccine or measles-,mumps-, rubella-containing vaccine.
Administration or planned administration of a vaccine not foreseen by the studyprotocol in the period starting 30 days before the dose and ending at 43 days afterthe dose of study interventions administration* (Visit 3), with the exception of:
inactivated influenza (flu) vaccine which may be given at any time during thestudy and administered at a different location than the study interventionsand,
routinely recommended licensed childhood DTPa-containing vaccines which canpreferably be co-administered according to the local immunization practices ofthe participating country.
Any other age-appropriate vaccine may be given starting at Visit 3 and anytimethereafter.
In case an emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authoritiesoutside the routine immunization program, the time period described above canbe reduced if necessary for that vaccine, provided it is used according to thelocal government recommendations and that GSK/IQVIA is notified accordingly.
Prior/Concurrent Clinical Study Experience
• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).
Other Exclusions
Child in care.
Any study personnel's immediate dependents, family, or household members.
Participants with the following high-risk individuals in their household:
Immunocompromised individuals
Pregnant women without documented history of varicella.
Newborn infants of mothers without documented history of varicella.
Newborn infants born <28 weeks of gestation.
Study Design
Study Description
Connect with a study center
GSK Investigational Site
Bahia Blanca, Buenos Aires 8001
ArgentinaSite Not Available
GSK Investigational Site
Buenos Aires, C1430BKC
ArgentinaSite Not Available
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, C1426BOR
ArgentinaSite Not Available
GSK Investigational Site
Rio Cuarto, 5800
ArgentinaSite Not Available
GSK Investigational Site
Macul, 7810000
ChileSite Not Available
GSK Investigational Site
Acacias, 507001
ColombiaSite Not Available
GSK Investigational Site
Barranquilla, 760002
ColombiaSite Not Available
GSK Investigational Site
Bogota, 38007
ColombiaSite Not Available
GSK Investigational Site
Chía, 250001
ColombiaSite Not Available
GSK Investigational Site
Medellin, 50034
ColombiaSite Not Available
GSK Investigational Site
Yopal, Casanare, 850001
ColombiaSite Not Available
GSK Investigational Site
Riga, LV1002
LatviaSite Not Available
GSK Investigational Site
San Juan, 00918
Puerto RicoSite Not Available
GSK Investigational Site
Boadilla Del Monte (Madrid), 28660
SpainSite Not Available
GSK Investigational Site
Madrid, 28007
SpainSite Not Available
GSK Investigational Site
Taichung, 407
TaiwanSite Not Available
GSK Investigational Site
Taipei, 10449
TaiwanSite Not Available
GSK Investigational Site
Taoyuan, 333
TaiwanSite Not Available
GSK Investigational Site
Adana, 1300
TurkeySite Not Available
GSK Investigational Site
Ankara, 6100
TurkeySite Not Available
GSK Investigational Site
Izmir, 35210
TurkeySite Not Available
GSK Investigational Site
Kayseri, 38039
TurkeySite Not Available
GSK Investigational Site
Kocaeli, 41380
TurkeySite Not Available
GSK Investigational Site
Birmingham, Alabama 35235
United StatesSite Not Available
GSK Investigational Site
Jonesboro, Arkansas 72401
United StatesSite Not Available
GSK Investigational Site
Bellflower, California 90706
United StatesSite Not Available
GSK Investigational Site
Huntington Park, California 90255
United StatesSite Not Available
GSK Investigational Site
Los Angeles, California 90025
United StatesSite Not Available
GSK Investigational Site
Oakland, California 94611
United StatesSite Not Available
GSK Investigational Site
Roseville, California 95661
United StatesSite Not Available
GSK Investigational Site
Sacramento, California 95815
United StatesSite Not Available
GSK Investigational Site
San Jose, California 95119
United StatesSite Not Available
GSK Investigational Site
Santa Clara, California 95051
United StatesSite Not Available
GSK Investigational Site
Walnut Creek, California 94596
United StatesSite Not Available
GSK Investigational Site
West Covina, California 91790
United StatesSite Not Available
GSK Investigational Site
Miami Lakes, Florida 33014
United StatesSite Not Available
GSK Investigational Site
Tampa, Florida 33613
United StatesSite Not Available
GSK Investigational Site
Ammon, Idaho 83406
United StatesSite Not Available
GSK Investigational Site
Idaho Falls, Idaho 83404
United StatesSite Not Available
GSK Investigational Site
Louisville, Kentucky 40291
United StatesSite Not Available
GSK Investigational Site
Lafayette, Louisiana 70508
United StatesSite Not Available
GSK Investigational Site
Boston, Massachusetts 02118
United StatesSite Not Available
GSK Investigational Site
Bingham Farms, Michigan 48025
United StatesSite Not Available
GSK Investigational Site
Detroit, Michigan 48201
United StatesSite Not Available
GSK Investigational Site
Lincoln, Nebraska 68522
United StatesSite Not Available
GSK Investigational Site
Omaha, Nebraska 68114
United StatesSite Not Available
GSK Investigational Site
East Orange, New Jersey 07108
United StatesSite Not Available
GSK Investigational Site
Syracuse, New York 13210
United StatesSite Not Available
GSK Investigational Site
Cleveland, Ohio 44121
United StatesSite Not Available
GSK Investigational Site
Dayton, Ohio 45414
United StatesSite Not Available
GSK Investigational Site
Fort Washington, Pennsylvania 19034
United StatesSite Not Available
GSK Investigational Site
Charleston, South Carolina 29407
United StatesSite Not Available
GSK Investigational Site
Simpsonville, South Carolina 29681
United StatesSite Not Available
GSK Investigational Site
Tullahoma, Tennessee 37388
United StatesSite Not Available
GSK Investigational Site
Dickinson, Texas 77539
United StatesSite Not Available
GSK Investigational Site
Edinburg, Texas 78542
United StatesSite Not Available
GSK Investigational Site
Houston, Texas 77008
United StatesSite Not Available
GSK Investigational Site
McAllen, Texas 78504
United StatesSite Not Available
GSK Investigational Site
Richmond, Texas 77469
United StatesSite Not Available
GSK Investigational Site
Layton, Utah 84041
United StatesSite Not Available
GSK Investigational Site
Murray, Utah 84107
United StatesSite Not Available
GSK Investigational Site
Provo, Utah 84604
United StatesSite Not Available
GSK Investigational Site
Roy, Utah 84067
United StatesSite Not Available
GSK Investigational Site
South Jordan, Utah 84095
United StatesSite Not Available
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