Phase
Condition
Rash
Shingles
Treatment
Marketed varicella vaccine_Lot 1
Investigational varicella vaccine_Lot 1
Investigational varicella vaccine_Lot 2
Clinical Study ID
Ages 12-15 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant's parent(s) Legally acceptable representatives /(LAR[s]), who, in theopinion of the investigator, can and will comply with the requirements of theprotocol (e.g., completion of the eDiaries, return for follow-up visits).
Written or witnessed/thumb printed informed consent obtained from the participant'sparent(s)/LAR(s) prior to performance of any study-specific procedure.
Healthy participants as established by medical history and clinical examinationbefore entering into the study.
A male or female between, and including, 12 to 15 months of age (i.e., from the dayof 1-year birthday until the day before 16 months of age) at the time of theadministration of study interventions.
Only for children in countries where PCV is recommended at 12 to 15 months of age asper national immunization schedule and provided as part of the study interventions:
Participant who previously received the primary series of PCV in the first yearof life with last dose at least 60 days prior to study entry.
Exclusion
Exclusion Criteria:
History of any reaction or hypersensitivity likely to be exacerbated by anycomponent of the study interventions.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based onmedical history and physical examination.
Hypersensitivity to latex.
Major congenital defects, as assessed by the investigator.
Recurrent history of uncontrolled neurological disorders or seizures.
History of varicella disease.
Active untreated tuberculosis.
Any other clinical condition that, in the opinion of the investigator, might poseadditional risk to the participant due to participation in the study.
Use of any investigational or non-registered product (drug, vaccine or invasivemedical device) other than the study interventions during the period beginning 30days before the dose of study interventions administration (Day -29 to Day 1), ortheir planned use during the study period.
Planned administration of a vaccine in the period starting 30 days before the doseand ending 43 days after the dose of study interventions administration* (Visit 2)with the exception of inactivated influenza vaccine which may be given at any timeduring the study and administered at a different location than the studyinterventions.
Any other age-appropriate vaccine may be given starting at Visit 2 and anytime thereafter.
*If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced provided it is used according to the local governmental recommendations and sponsor is notified
Chronic administration of immune-modifying drugs (defined as more than 14consecutive days in total) and/or planned use of long-acting immune modifyingtreatments at any time up to the end of the study.
Up to 90 days prior to the study intervention administration:
For corticosteroids, this will mean prednisone equivalent >=0.5 mg/kg/day withmaximum of 20 mg/day for pediatric participants. Inhaled and topical steroidsare allowed.
Administration of immunoglobulins and/or any blood products or plasmaderivatives.
Up to 180 days prior to study interventions administration: long actingimmune-modifying drugs including among others immunotherapy (e.g., tumornecrosis factor-inhibitors), monoclonal antibodies (except the ones notinterfering with the immune response to the study vaccines, e.g., nirsevimab),antitumoral medication.
Previous vaccination against measles, mumps, and rubella.
Previous vaccination against hepatitis A virus.
Previous vaccination against varicella virus.
Only for children in countries where PCV is recommended at 12 to 15 months of age asper national immunization schedule and provided as part of the study interventions,participant who previously received a booster dose of any PCV.
Concurrently participating in another clinical study, at any time during the studyperiod, in which the participant has been or will be exposed to an investigationalor a non-investigational intervention (drug/invasive medical device).
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 less than (<) 28 weeks of gestation.
Study Design
Connect with a study center
GSK Investigational Site
Leuven, 3000
BelgiumSite Not Available
GSK Investigational Site
Liege, 4000
BelgiumSite Not Available
GSK Investigational Site
Bogota, 110221
ColombiaSite Not Available
GSK Investigational Site
Chia, 250001
ColombiaSite Not Available
GSK Investigational Site
Medellin, 050018
ColombiaSite Not Available
GSK Investigational Site
Santo Domingo, 10201
Dominican RepublicSite Not Available
GSK Investigational Site
Santo Domingo Oeste, 11114
Dominican RepublicSite Not Available
GSK Investigational Site
Paide, 72713
EstoniaSite Not Available
GSK Investigational Site
Tartu, 50106
EstoniaSite Not Available
GSK Investigational Site
Acapulco, 39670
MexicoSite Not Available
GSK Investigational Site
Merida, 97000
MexicoSite Not Available
GSK Investigational Site
Bydgoszcz, 85-048
PolandSite Not Available
GSK Investigational Site
Krakow, 30-363
PolandSite Not Available
GSK Investigational Site
San Juan, 907
Puerto RicoSite Not Available
GSK Investigational Site
Abu Dhabi,
United Arab EmiratesSite Not Available
GSK Investigational Site
Paramount, California 90723
United StatesSite Not Available
GSK Investigational Site
Sacramento, California 95823
United StatesSite Not Available
GSK Investigational Site
Ventura, California 93003
United StatesSite Not Available
GSK Investigational Site
Miami, Florida 33176
United StatesSite Not Available
GSK Investigational Site
Miami Lakes, Florida 33014
United StatesSite Not Available
GSK Investigational Site
Tampa, Florida 33613
United StatesActive - Recruiting
GSK Investigational Site
Topeka, Kansas 66606
United StatesSite Not Available
GSK Investigational Site
Louisville, Kentucky 40202-1822
United StatesSite Not Available
GSK Investigational Site
Fall River, Massachusetts 02721-1735
United StatesSite Not Available
GSK Investigational Site
Bingham Farms, Michigan 48025
United StatesActive - Recruiting
GSK Investigational Site
Lincoln, Nebraska 68510
United StatesSite Not Available
GSK Investigational Site
Fayetteville, North Carolina 30214
United StatesSite Not Available
GSK Investigational Site
Monroe, North Carolina 28112
United StatesSite Not Available
GSK Investigational Site
Cleveland, Ohio 44121
United StatesSite Not Available
GSK Investigational Site
Charleston, South Carolina 29414
United StatesSite Not Available
GSK Investigational Site
Longview, Texas 75605
United StatesSite Not Available
GSK Investigational Site
McAllen, Texas 78504
United StatesActive - Recruiting
GSK Investigational Site
San Antonio, Texas 77030
United StatesSite Not Available
GSK Investigational Site
Layton, Utah 84041
United StatesActive - Recruiting
GSK Investigational Site
Madison, Wisconsin 53715-1218
United StatesSite Not Available
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