Phase
Condition
Shingles
Rash
Treatment
Investigational varicella vaccine
PCV (pneumococcal conjugate vaccine) 13
Measles, mumps, and rubella vaccine
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 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 year oflife 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 (no laboratory testing required).
Hypersensitivity to latex.
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 2and anytime thereafter.
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/daywith maximum of 20 mg/day for pediatric participants. Inhaled and topicalsteroids are allowed.
Administration of immunoglobulins and/or any blood products or plasmaderivatives.
Up to 180 days prior to study interventions administration: long acting immunemodifying drugs including among others immunotherapy (e.g., tumor necrosisfactor-inhibitors), monoclonal antibodies (except the ones not interfering withthe immune response to the study vaccines, e.g., nirsevimab), antitumoralmedication.
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
Burgas, 8008
BulgariaSite Not Available
GSK Investigational Site
Gabrovo, 5300
BulgariaSite Not Available
GSK Investigational Site
Kyustendil, 2500
BulgariaSite Not Available
GSK Investigational Site
Plovdiv, 4002
BulgariaSite Not Available
GSK Investigational Site
Ruse, 7000
BulgariaSite Not Available
GSK Investigational Site
Sevlievo, 5400
BulgariaSite Not Available
GSK Investigational Site
Yambol, 8600
BulgariaSite Not Available
GSK Investigational Site
Aarhus N, 8200
DenmarkSite Not Available
GSK Investigational Site
Copenhagen, DK-2100
DenmarkSite Not Available
GSK Investigational Site
Hvidovre, 2650
DenmarkSite Not Available
GSK Investigational Site
Odense C, DK-5000
DenmarkSite Not Available
GSK Investigational Site
Tallinn, 10615
EstoniaSite Not Available
GSK Investigational Site
Hong Kong, 00852
Hong KongSite Not Available
GSK Investigational Site
Shatin,
Hong KongSite Not Available
GSK Investigational Site
Kaunas, 47116
LithuaniaSite Not Available
GSK Investigational Site
Durango, 34000
MexicoSite Not Available
GSK Investigational Site
Tlalpan, 14340
MexicoSite Not Available
GSK Investigational Site
Bydgoszcz, 85-796
PolandSite Not Available
GSK Investigational Site
Trzebnica, 55-100
PolandSite Not Available
GSK Investigational Site
Warszawa, 02-172
PolandSite Not Available
GSK Investigational Site
Phoenix, Arizona 85006
United StatesSite Not Available
GSK Investigational Site
Tucson, Arizona 85741
United StatesSite Not Available
GSK Investigational Site
Huntington Park, California 90255
United StatesSite Not Available
GSK Investigational Site
National City, California 91950
United StatesSite Not Available
GSK Investigational Site
West Covina, California 91790
United StatesActive - Recruiting
GSK Investigational Site
Hialeah, Florida 33012
United StatesSite Not Available
GSK Investigational Site
Miami, Florida 33134
United StatesSite Not Available
GSK Investigational Site
Chicago, Illinois 60621
United StatesSite Not Available
GSK Investigational Site
El Dorado, Kansas 67042
United StatesSite Not Available
GSK Investigational Site
Lafayette, Louisiana 70508
United StatesSite Not Available
GSK Investigational Site
Mankato, Minnesota 56002
United StatesSite Not Available
GSK Investigational Site
Lincoln, Nebraska 68516
United StatesSite Not Available
GSK Investigational Site
Cincinnati, Ohio 45245
United StatesSite Not Available
GSK Investigational Site
Dallas, Texas 75235
United StatesSite Not Available
GSK Investigational Site
Houston, Texas 77065
United StatesSite Not Available
GSK Investigational Site
Richmond, Texas 77469
United StatesSite Not Available
GSK Investigational Site
San Antonio, Texas 78244
United StatesSite Not Available
GSK Investigational Site
Syracuse, Utah 84075
United StatesSite Not Available
GSK Investigational Site
Vienna, Virginia 22180
United StatesSite Not Available
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