[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573004":3},{"organization":4,"outcomesModule":7,"designInfo":77,"detailedDescription":25,"studyPopulation":25,"armGroups":87,"interventions":120,"overallOfficials":25,"centralContacts":162,"locations":171,"responsibleParty":1386,"collaborators":25,"id":1388,"slug":1389,"hasResults":1390,"nctId":1391,"briefTitle":1392,"officialTitle":1393,"acronym":25,"eligibilityCriteria":1394,"healthyVolunteers":1395,"sex":1396,"minAge":1397,"maxAge":1398,"enrollmentInfo":1399,"targetDuration":25,"studyType":1402,"phases":1403,"briefSummary":1405,"conditions":1406,"keywords":1408,"overallStatus":174,"whyStopped":25,"lastUpdateSubmitDate":1414,"lastUpdatePostDateStruct":1415,"startDateStruct":1418,"completionDateStruct":1420,"leadSponsor":1422,"locationsCount":1423},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":25},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) Immunoglobulin (IgG) for the 3 lots of VNS vaccine groups","Seroresponse is defined as post-vaccination (Day 43) anti-VZV gE IgG antibody concentration greater than or equal to (\\>=) 300 milli-international units per milliliter (mIU\u002FmL) among participants who were seronegative \\[(antibody concentration less than (\\\u003C) LLOQ (Lower limit of quantification)\\] before vaccination. A seronegative participant is a participant whose antibody concentration is below the LLOQ of the assay. A seropositive participant is a participant whose antibody concentration is greater than or equal to the LLOQ of the assay.","At Day 43",{"measure":14,"description":15,"timeFrame":12},"Geometric Mean Concentration (GMC) of anti-VZV gE IgG for the 3 lots of VNS vaccine groups","Concentrations of anti-VZV gE IgG presented as GMCs and expressed in mIU\u002FmL for each group.",{"measure":17,"description":18,"timeFrame":12},"Percentage of participants with seroresponse to anti-VZV gE IgG for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups","Seroresponse is defined as post-vaccination (Day 43) anti-VZV gE IgG concentration \\>= 300 mIU\u002FmL among participants who were seronegative (antibody concentration \\\u003C LLOQ) before vaccination. A seronegative participant is a participant whose antibody concentration is below the LLOQ of the assay. A seropositive participant is a participant whose antibody concentration is greater than or equal to the LLOQ of the assay.",{"measure":20,"description":21,"timeFrame":12},"GMCs of anti-VZV gE IgG for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups","Concentrations of anti-VZV gE IgG are presented as GMCs and expressed in mIU\u002FmL for each group.",[23,26,28,30,33,36,39,41,44,47,50,54,58,62,65,67,70,74],{"measure":24,"description":25,"timeFrame":12},"Anti-measles antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups",null,{"measure":27,"description":25,"timeFrame":12},"Anti-mumps antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups",{"measure":29,"description":25,"timeFrame":12},"Anti-rubella antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups",{"measure":31,"description":32,"timeFrame":12},"Percentage of participants with seroresponse to anti-measles for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups","Seroresponse is defined as post-vaccination (Day 43) anti-measles antibody concentration \\>= cut-off value among participants who were seronegative (antibody concentration \\\u003C cut-off value) before vaccination.\n\nThe assay cut-off values for anti-measles will be defined by the laboratory before the analysis.",{"measure":34,"description":35,"timeFrame":12},"Percentage of participants with seroresponse to anti-mumps for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups","Seroresponse is defined as post-vaccination (Day 43) anti-mumps antibody concentration \\>= cut-off value among participants who were seronegative (antibody concentration \\\u003C cut-off value) before vaccination.\n\nThe assay cut-off values for anti-mumps will be defined by the laboratory before the analysis.",{"measure":37,"description":38,"timeFrame":12},"Percentage of participants with seroresponse to anti-rubella for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups","Seroresponse is defined as post-vaccination (Day 43) anti-rubella antibody concentration \\>= cut-off value among participants who were seronegative (antibody concentration \\\u003C cut-off value) before vaccination.\n\nThe assay cut-off values for anti-rubella will be defined by the laboratory before the analysis.",{"measure":40,"description":25,"timeFrame":12},"Anti-Hepatitis A antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups in Hepatitis A virus (HAV) subset",{"measure":42,"description":43,"timeFrame":12},"Percentage of participants with seroresponse to anti-HAV for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups in HAV subset","Seroresponse is defined as post-vaccination (Day 43) anti-HAV antibody concentration \\>= cut-off value among participants who were seronegative (antibody concentration \\\u003C cut-off value) before vaccination.\n\nThe assay cut-off values for anti-HAV antibodies will be defined by the laboratory before the analysis.",{"measure":45,"description":46,"timeFrame":12},"Anti-S. pneumoniae serotype specific Polysaccharide IgG antibody concentrations for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups in PCV subset","S. pneumoniae polysaccharides to be tested: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.",{"measure":48,"description":49,"timeFrame":12},"Percentage of participants in the VNS vaccine pooled group with anti-VZV gE antibody concentrations above the adaptive seroresponse threshold","The adaptive seroresponse threshold is the anti-VZV gE IgG antibody concentration for which the response rate in the VV group is 95% or higher.",{"measure":51,"description":52,"timeFrame":53},"Percentage of participants reporting each solicited administration site event","Solicited administration site events include injection site redness, pain and swelling.","Day 1 (post-dose) to Day 4",{"measure":55,"description":56,"timeFrame":57},"Percentage of participants reporting each solicited systemic event","Solicited systemic events include drowsiness, loss of appetite and irritability.","Day 1 (post-dose) to Day 15",{"measure":59,"description":60,"timeFrame":61},"Percentage of participants reporting each solicited systemic event in terms of fever","Fever is defined as temperature greater than or equal to (\\>=)38.0 degrees Celsius (°C) by any route (the preferred location for measuring temperature is the axilla).","Day 1 (post-dose) to Day 22",{"measure":51,"description":63,"timeFrame":64},"Solicited administration site events include injection site varicella-like rash.","Day 1 (post-dose) to Day 43",{"measure":55,"description":66,"timeFrame":64},"Solicited systemic events include varicella-like rash (non-injection site) and general rash (not varicella-like).",{"measure":68,"description":69,"timeFrame":64},"Percentage of participants reporting unsolicited adverse events (AEs)","Unsolicited AEs include any AE reported in addition to solicited events during the study, or any \"solicited\" symptoms with onset outside of the specified period of follow-up for solicited symptoms, are assessed for each group after the administration of all vaccines.",{"measure":71,"description":72,"timeFrame":73},"Percentage of participants reporting medically attended AEs (MAAE)","A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to\u002Fby a healthcare professional.","Day 1 (post-dose) to Day 181 (study end)",{"measure":75,"description":76,"timeFrame":73},"Percentage of participants reporting serious adverse events (SAEs)","A SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability\u002Fincapacity, or other situations that are considered serious per medical or scientific judgment.",{"allocation":78,"interventionModel":79,"interventionModelDescription":25,"primaryPurpose":80,"observationalModel":25,"timePerspective":25,"maskingInfo":81},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":82,"maskingDescription":83,"whoMasked":84},"DOUBLE","Observer-blind study.",[85,86],"PARTICIPANT","INVESTIGATOR",[88,99,104,109,115],{"label":89,"type":90,"description":91,"interventionNames":92},"VNS_Lot 1 Group","EXPERIMENTAL","Participants receive 1 dose of the investigational VNS vaccine of Lot 1, 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A vaccine (HAV), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.",[93,94,95,96,97,98],"Biological: Investigational varicella vaccine_Lot 1","Biological: MMR vaccine","Biological: Hepatitis A vaccine","Biological: PCV (pneumococcal conjugate vaccine) 13","Biological: PCV 20","Biological: Vaxneuvance",{"label":100,"type":90,"description":101,"interventionNames":102},"VNS_Lot 2 Group","Participants receive 1 dose of the investigational VNS vaccine of Lot 2, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.",[103,94,95,96,97,98],"Biological: Investigational varicella vaccine_Lot 2",{"label":105,"type":90,"description":106,"interventionNames":107},"VNS_Lot 3 Group","Participants receive 1 dose of the investigational VNS vaccine of Lot 3, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.",[108,94,95,96,97,98],"Biological: Investigational varicella vaccine_Lot 3",{"label":110,"type":111,"description":112,"interventionNames":113},"VV_Lot 1 Group","ACTIVE_COMPARATOR","Participants receive 1 dose of a marketed varicella vaccine (VV) of Lot 1, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.",[114,94,95,96,97,98],"Biological: Marketed varicella vaccine_Lot 1",{"label":116,"type":111,"description":117,"interventionNames":118},"VV_Lot 2 Group","Participants receive 1 dose of a marketed VV of Lot 2, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.",[119,94,95,96,97,98],"Biological: Marketed varicella vaccine_Lot 2",[121,126,130,134,138,142,146,150,154,158],{"type":122,"name":123,"description":124,"armGroupLabels":125,"otherNames":25},"BIOLOGICAL","Investigational varicella vaccine_Lot 1","Investigational varicella vaccine of Lot 1 administered subcutaneously.",[89],{"type":122,"name":127,"description":128,"armGroupLabels":129,"otherNames":25},"Investigational varicella vaccine_Lot 2","Investigational varicella vaccine of Lot 2 administered subcutaneously.",[100],{"type":122,"name":131,"description":132,"armGroupLabels":133,"otherNames":25},"Investigational varicella vaccine_Lot 3","Investigational varicella vaccine of Lot 3 administered subcutaneously.",[105],{"type":122,"name":135,"description":136,"armGroupLabels":137,"otherNames":25},"Marketed varicella vaccine_Lot 1","Marketed varicella vaccine of Lot 1 administered subcutaneously.",[110],{"type":122,"name":139,"description":140,"armGroupLabels":141,"otherNames":25},"Marketed varicella vaccine_Lot 2","Marketed varicella vaccine of Lot 2 administered subcutaneously.",[116],{"type":122,"name":143,"description":144,"armGroupLabels":145,"otherNames":25},"MMR vaccine","MMR vaccine co-administered subcutaneously or intramuscularly.",[89,100,105,110,116],{"type":122,"name":147,"description":148,"armGroupLabels":149,"otherNames":25},"Hepatitis A vaccine","Hepatitis A vaccine co-administered intramuscularly.",[89,100,105,110,116],{"type":122,"name":151,"description":152,"armGroupLabels":153,"otherNames":25},"PCV (pneumococcal conjugate vaccine) 13","The 13-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.",[89,100,105,110,116],{"type":122,"name":155,"description":156,"armGroupLabels":157,"otherNames":25},"PCV 20","The 20-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.",[89,100,105,110,116],{"type":122,"name":159,"description":160,"armGroupLabels":161,"otherNames":25},"Vaxneuvance","The Vaxneuvance (15-valent pneumococcal conjugate vaccine) co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.",[89,100,105,110,116],[163,168],{"name":164,"role":165,"phone":166,"phoneExt":25,"email":167},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":169,"role":165,"phone":170,"phoneExt":25,"email":167},"EU GSK Clinical Trials Call Center","+44 (0) 20 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