[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578041":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":61,"studyPopulation":61,"armGroups":71,"interventions":93,"overallOfficials":61,"centralContacts":123,"locations":132,"responsibleParty":219,"collaborators":61,"id":221,"slug":222,"hasResults":223,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":61,"eligibilityCriteria":227,"healthyVolunteers":228,"sex":229,"minAge":230,"maxAge":231,"enrollmentInfo":232,"targetDuration":61,"studyType":235,"phases":236,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":135,"whyStopped":61,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":61},[9,13],{"measure":10,"description":11,"timeFrame":12},"Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) IgG for 2 doses of VNS vaccine compared to 2 doses of VV","Seroresponse is defined as post-vaccination (Day 43 post Dose 2) anti VZV gE Immunoglobulin (IgG) concentration greater than equal to (\\>=) 300 milli-international units per milliliter (mIU\u002FmL).","At Day 133 (43 days post-dose 2)",{"measure":14,"description":15,"timeFrame":16},"Geometric Mean Concentration (GMC) of anti-VZV gE IgG for 2 doses of VNS vaccine compared to 2 doses of VV","Concentrations of anti-VZV gE IgG are presented as GMC and expressed in mIU\u002FmL for each group.","At Day 133 (within 43 days post-dose 2)",[18,21,23,27,29,33,35,39,42,45,47,49,50,53,54,58],{"measure":19,"description":20,"timeFrame":16},"Percentage of participants with seroresponse to anti-VZV gE IgG for VV-VNS group","Seroresponse is defined as post-vaccination (Day 43 post Dose 2) anti-VZV gE IgG concentration \\>= 300 mIU\u002FmL.",{"measure":22,"description":15,"timeFrame":16},"GMC of anti-VZV gE IgG for VV-VNS group",{"measure":24,"description":25,"timeFrame":26},"Percentage of participants reporting each solicited administration site event","Solicited administration site events include injection site redness, pain and swelling.","Day 1 (post-dose 1) to Day 4",{"measure":24,"description":25,"timeFrame":28},"Day 91 (post-dose 2) to Day 94",{"measure":30,"description":31,"timeFrame":32},"Percentage of participants reporting each solicited systemic event","Solicited systemic events include drowsiness, loss of appetite and irritability.","Day 1 (post-dose 1) to Day 15",{"measure":30,"description":31,"timeFrame":34},"Day 91 (post-dose 2) to Day 105",{"measure":36,"description":37,"timeFrame":38},"Percentage of participants reporting each solicited systemic event in terms of fever","Fever is defined as temperature \\>=38.0 degrees Celsius (°C) by any route (the preferred location for measuring temperature is the axilla).","Day 1 (post-dose 1) to Day 22",{"measure":36,"description":40,"timeFrame":41},"Fever is defined as temperature \\>=38.0 degrees °C by any route (the preferred location for measuring temperature is the axilla).","Day 91 (post-dose 2) to Day 112",{"measure":24,"description":43,"timeFrame":44},"Solicited administration site include injection site varicella-like rash.","Day 1 (post-dose 1) to Day 43",{"measure":24,"description":43,"timeFrame":46},"Day 91 (post-dose 2) to Day 133",{"measure":30,"description":48,"timeFrame":44},"Solicited systemic events includes varicella-like rash (non-injection site), and general rash (not varicella-like).",{"measure":30,"description":48,"timeFrame":46},{"measure":51,"description":52,"timeFrame":44},"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":51,"description":52,"timeFrame":46},{"measure":55,"description":56,"timeFrame":57},"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 1) to Day 271 (study end)",{"measure":59,"description":60,"timeFrame":57},"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.",null,{"allocation":63,"interventionModel":64,"interventionModelDescription":61,"primaryPurpose":65,"observationalModel":61,"timePerspective":61,"maskingInfo":66},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":67,"maskingDescription":68,"whoMasked":69},"SINGLE","Observer-blind study.",[70],"PARTICIPANT",[72,83,89],{"label":73,"type":74,"description":75,"interventionNames":76},"VV-VV Group","ACTIVE_COMPARATOR","Participants receive 2 doses of a VV vaccine on Day 1 and Day 91. 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. A second dose of MMR vaccine will be co-administered to the participants in countries where a second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.",[77,78,79,80,81,82],"Biological: Marketed varicella vaccine","Biological: MMR vaccine","Biological: Hepatitis A vaccine","Biological: PCV (pneumococcal conjugate vaccine) 13","Biological: PCV 20","Biological: Vaxneuvance",{"label":84,"type":85,"description":86,"interventionNames":87},"VNS-VNS Group","EXPERIMENTAL","Participants receive 2 doses of a VNS vaccine on Day 1 and Day 91. 1 doses of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.",[88,78,79,80,81,82],"Biological: Investigational varicella vaccine",{"label":90,"type":85,"description":91,"interventionNames":92},"VV-VNS Group","Participants receive 1 dose of VV vaccine on Day 1, 1 dose of VNS Vaccine on Day 91. 1 doses of MMR vaccine, 1 dose of HAV, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.",[88,77,78,79,80,81,82],[94,99,103,107,111,115,119],{"type":95,"name":96,"description":97,"armGroupLabels":98,"otherNames":61},"BIOLOGICAL","Investigational varicella vaccine","Investigational varicella vaccine administered subcutaneously.",[84,90],{"type":95,"name":100,"description":101,"armGroupLabels":102,"otherNames":61},"Marketed varicella vaccine","Marketed varicella vaccine administered subcutaneously.",[90,73],{"type":95,"name":104,"description":105,"armGroupLabels":106,"otherNames":61},"MMR vaccine","MMR vaccine co-administered subcutaneously or intramuscularly.",[84,90,73],{"type":95,"name":108,"description":109,"armGroupLabels":110,"otherNames":61},"Hepatitis A vaccine","Hepatitis A vaccine co-administered intramuscularly.",[84,90,73],{"type":95,"name":112,"description":113,"armGroupLabels":114,"otherNames":61},"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.",[84,90,73],{"type":95,"name":116,"description":117,"armGroupLabels":118,"otherNames":61},"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.",[84,90,73],{"type":95,"name":120,"description":121,"armGroupLabels":122,"otherNames":61},"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.",[84,90,73],[124,129],{"name":125,"role":126,"phone":127,"phoneExt":61,"email":128},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":130,"role":126,"phone":131,"phoneExt":61,"email":128},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",[133,155,168,181,196,209],{"facility":134,"status":135,"city":136,"state":137,"zip":138,"country":139,"countryCode":140,"cosmosGeoPoint":141,"geoPoint":146,"contacts":147},"GSK Investigational Site","RECRUITING","Salvaleón de Higüey","La Altagracia Province","23000","Dominican Republic","DO",{"type":142,"coordinates":143},"Point",[144,145],-68.70798,18.61501,{"lat":145,"lon":144},[148,149,152],{"name":125,"role":126,"phone":127,"phoneExt":61,"email":128},{"name":150,"role":126,"phone":151,"phoneExt":61,"email":128},"EU GSK Clinical Trials Call Centre","+44 (0) 20 8990 4466",{"name":153,"role":154,"phone":61,"phoneExt":61,"email":61},"Fior Stephane Severino Medina","PRINCIPAL_INVESTIGATOR",{"facility":134,"status":135,"city":156,"state":61,"zip":157,"country":139,"countryCode":140,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Constanza","11201",{"type":142,"coordinates":159},[160,161],-70.74499,18.90919,{"lat":161,"lon":160},[164,165,166],{"name":125,"role":126,"phone":127,"phoneExt":61,"email":128},{"name":150,"role":126,"phone":151,"phoneExt":61,"email":128},{"name":167,"role":154,"phone":61,"phoneExt":61,"email":61},"Demian Arturo Herrera Morban",{"facility":134,"status":135,"city":169,"state":61,"zip":170,"country":139,"countryCode":140,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Santo Domingo Oeste","11906",{"type":142,"coordinates":172},[173,174],-70,18.5,{"lat":174,"lon":173},[177,178,179],{"name":125,"role":126,"phone":127,"phoneExt":61,"email":128},{"name":150,"role":126,"phone":151,"phoneExt":61,"email":128},{"name":180,"role":154,"phone":61,"phoneExt":61,"email":61},"Luis Martinez",{"facility":134,"status":135,"city":182,"state":61,"zip":183,"country":184,"countryCode":185,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"San Pedro Sula","21104","Honduras","HN",{"type":142,"coordinates":187},[188,189],-88.02588,15.50585,{"lat":189,"lon":188},[192,193,194],{"name":125,"role":126,"phone":127,"phoneExt":61,"email":128},{"name":150,"role":126,"phone":151,"phoneExt":61,"email":128},{"name":195,"role":154,"phone":61,"phoneExt":61,"email":61},"Agustin Bueso",{"facility":134,"status":135,"city":197,"state":61,"zip":198,"country":184,"countryCode":185,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Tegucigalpa","11101",{"type":142,"coordinates":200},[201,202],-87.20681,14.0818,{"lat":202,"lon":201},[205,206,207],{"name":125,"role":126,"phone":127,"phoneExt":61,"email":128},{"name":150,"role":126,"phone":151,"phoneExt":61,"email":128},{"name":208,"role":154,"phone":61,"phoneExt":61,"email":61},"Bessy Italia Turcios Gomez",{"facility":134,"status":135,"city":197,"state":61,"zip":210,"country":184,"countryCode":185,"cosmosGeoPoint":211,"geoPoint":213,"contacts":214},"2449",{"type":142,"coordinates":212},[201,202],{"lat":202,"lon":201},[215,216,217],{"name":125,"role":126,"phone":127,"phoneExt":61,"email":128},{"name":150,"role":126,"phone":151,"phoneExt":61,"email":128},{"name":218,"role":154,"phone":61,"phoneExt":61,"email":61},"Pamela Zacasa Vargas",{"type":220,"investigatorFullName":61,"investigatorTitle":61,"investigatorAffiliation":61,"oldNameTitle":61,"oldOrganization":61},"SPONSOR","100578041","phase-3-a-study-on-the-immune-response-and-safety-of-the-second-dose-of-an-investigational-chickenpox-vaccine-when-given-to-healthy-children-3-months-after-a-first-dose-at-12-to-15-months-of-age-100578041",false,"NCT06806137","A Study on the Immune Response and Safety of the Second Dose of an Investigational Chickenpox Vaccine When Given to Healthy Children 3 Months After a First Dose at 12 to 15 Months of Age","A Phase 3a, Observer-blind, Randomized, Controlled, Study to Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax, When Given as a Second Dose to Healthy Children, 3 Months After the Administration of a First Dose at 12 to 15 Months of Age","Inclusion Criteria:\n\n* Participant's parent(s)\u002FLegally acceptable representative (LAR)(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol\n* Written or witnessed\u002Fthumb printed informed consent obtained from the participant's parent(s)\u002FLAR(s) prior to performance of any study-specific procedure.\n* Healthy participants as established by medical history and clinical examination before entering into the study.\n* A male or female between, and including, 12 to 15 months of age (i.e., from the day of 1 year birthday until the day before 16 months of age) at the time of the administration of the first study interventions.\n* Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions: participant who previously received the primary series of PCV in the first year of life with last dose at least 60 days prior to study entry.\n\nExclusion Criteria:\n\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n* Hypersensitivity to latex.\n* Major congenital defects, as assessed by the investigator.\n* Recurrent history of uncontrolled neurological disorders or seizures.\n* History of varicella disease.\n* Active untreated tuberculosis.\n* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.\n* Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions (Day -29 to Day 1), or their planned use during the study period.\n* Planned administration of a vaccine in the period starting 30 days before the first dose and ending 43 days after the second dose of study interventions administration (Visit 3), with the exception of inactivated influenza vaccine which may be given at any time during the study and administered at a different location than the study interventions.\n* Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and\u002For planned use of long-acting immune-modifying treatments at any time up to the end of the study.\n\n  * Up to 90 days prior to the study intervention administration:\n\n    i) For corticosteroids, this will mean prednisone equivalent \\>=0.5 mg\u002Fkg\u002Fday with maximum of 20 mg\u002Fday for pediatric participants. Inhaled and topical steroids are allowed.\n\nii) Administration of immunoglobulins and\u002For any blood products or plasma derivatives.\n\n* Up to 180 days prior to study interventions administration: long acting immune-modifying drugs including among others immunotherapy (e.g., tumor necrosis factor-inhibitors), monoclonal antibodies (except the ones not interfering with the immune response to the study vaccinese.g., nirsevimab), antitumoral medication.\n* Previous vaccination against measles, mumps, and rubella.\n* Previous vaccination against hepatitis A virus.\n* Previous vaccination against varicella virus.\n* Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions, participant who previously received a booster dose of any PCV.\n* 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\u002Finvasive medical device).\n* Child in care.\n* Any study personnel's immediate dependents, family, or household members.\n* Participants with the following high-risk individuals in their household:\n\n  i) Immunocompromised individuals. ii) Pregnant women without documented history of varicella. iii) Newborn infants of mothers without documented history of varicella. iv) Newborn infants born less than (\\\u003C) 28 weeks of gestation.",true,"ALL","12 Months","15 Months",{"count":233,"type":234},600,"ESTIMATED","INTERVENTIONAL",[237],"PHASE3","The purpose of this study is to evaluate the immune response and safety of GSKs investigational varicella vaccine (VNS Vaccine) compared to an already approved varicella vaccine, Varivax (VV), when administered as second dose to healthy children. 3 months after first dose at 12 to 15 months. The study will be conducted in children who have not previously contracted varicella or received a varicella vaccination.",[240],"Chickenpox",[242,243,244,245],"Chicken pox","Investigational varicella vaccine (VNS) Varicella","Varivax (VV)","Healthy Children","2026-05-27",{"date":248,"type":249},"2026-05-29","ACTUAL",{"date":251,"type":249},"2025-05-15",{"date":253,"type":234},"2027-05-03",{"name":5,"class":6},6]