[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chickenpox\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chickenpox":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,70,91],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100581811","phase-3-a-study-on-the-immune-response-and-safety-of-an-investigational-chickenpox-vaccine-and-a-marketed-measles-mumps-and-rubella-vaccine-when-administered-as-intramuscular-injection-to-healthy-children-12-to-15-months-of-age-100581811",false,"NCT06855160","A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age","A Phase 3a, Open-Label, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Intramuscular Administration of an Investigational Varicella Vaccine and Priorix Compared With Subcutaneous Administration of Varivax and Priorix, When Given as a First Dose to Healthy Children 12 to 15 Months of Age","Inclusion Criteria:\n\n* Participant's parent(s)\u002F Legally acceptable representatives (LAR\\[s\\]), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiaries, return for follow-up visits).\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 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:\n\n  * Participant who previously received the primary series of PCV in the first year of life with last dose at least 60 days prior to the administration of study intervention.\n\nExclusion Criteria:\n\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions including hypersensitivity to neomycin or gelatin.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).\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 measles, mumps, rubella, or varicella disease.\n* Active untreated tuberculosis.\n* Participants with bleeding disorders (e.g., thrombocytopenia or any coagulation disorder).\n* Condition that in the judgment of the investigator would make intramuscular injection unsafe.\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\nPrior\u002FConcomitant therapy\n\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 dose of study interventions administration (Day -29 to Day 1), or their planned use during the study period.\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* 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* 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 vaccines, e.g., nirsevimab), antitumoral medication.\n* Previous vaccination against measles, mumps, and rubella.\n* Previous vaccination against varicella virus.\n* Previous vaccination against hepatitis A 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\nPrior\u002FConcurrent clinical study experience\n\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\nOther exclusion criteria\n\n* Any study personnel or their immediate dependents, family, or household members.\n* Child in care.\n* Participants with the following high-risk individuals in their household: • Immunocompromised individuals.\n* Pregnant women without documented history of varicella.\n* Newborn infants of mothers without documented history of varicella.\n* Newborn infants born \\\u003C28 weeks of gestation",true,"ALL","12 Months","15 Months",{"count":21,"type":22},911,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This study aims to assess the immune response and safety of GSK's candidate chickenpox and marketed MMR vaccines when given to children 12 to 15 months of age via a muscle injection. It compares the GSK vaccines to Merck's chickenpox vaccine, administered just under the skin. Additionally, the study will evaluate the immune response and safety of giving the GSK vaccines along with other childhood vaccines through a muscle injection.",[28],"Chickenpox",[30,31,32,33,34],"Chicken pox","Candidate l varicella vaccine (VNS)","Varicella","Varivax","Healthy Children","RECRUITING","2026-05-27",{"date":38,"type":39},"2026-05-29","ACTUAL",{"date":41,"type":39},"2025-04-17",{"date":43,"type":22},"2027-02-02",{"name":45,"class":46},"GlaxoSmithKline","INDUSTRY",22,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"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","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.",{"count":56,"type":22},600,[25],"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.",[28],[30,61,62,34],"Investigational varicella vaccine (VNS) Varicella","Varivax (VV)",{"date":38,"type":39},{"date":65,"type":39},"2025-05-15",{"date":67,"type":22},"2027-05-03",{"name":45,"class":46},6,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100573004","phase-3-a-study-on-the-immune-response-and-safety-of-an-investigational-chickenpox-vaccine-when-given-to-healthy-children-12-to-15-months-of-age-100573004","NCT06740630","A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age","A Phase 3a, Observer-blind, Randomized, Controlled Study to Demonstrate Lot-to-lot Consistency and Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax, Administered as a First Dose to Healthy Children 12 to 15 Months of Age","Inclusion Criteria:\n\n* Participant's parent(s) Legally acceptable representatives \u002F(LAR\\[s\\]), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiaries, return for follow-up visits).\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 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:\n\n  * 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 dose of study interventions administration (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 dose and 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 time during the study and administered at a different location than the study interventions.\n\nAny other age-appropriate vaccine may be given starting at Visit 2 and anytime thereafter.\n\n\\*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\n\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  * 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  * Administration of immunoglobulins and\u002For any blood products or plasma derivatives.\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 vaccines, e.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  * Immunocompromised individuals.\n  * Pregnant women without documented history of varicella.\n  * Newborn infants of mothers without documented history of varicella.\n  * Newborn infants born less than (\\\u003C) 28 weeks of gestation.",{"count":78,"type":22},1840,[25],"The purpose of this study is to assess the consistency of immune response to three different lots of GSK's investigational varicella vaccine (VNS Vaccine), and to compare the safety and immune response of VNS vaccine to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted in healthy children aged 12 to 15 months, who have neither contracted varicella nor received a varicella vaccination.",[28],[30,83,32,33,34],"VNS",{"date":38,"type":39},{"date":86,"type":39},"2025-01-10",{"date":88,"type":22},"2027-05-17",{"name":45,"class":46},97,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":98,"targetDuration":4,"studyType":23,"phases":100,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},"100569411","phase-3-a-study-on-the-safety-of-an-investigational-chickenpox-vaccine-when-given-to-healthy-children-12-to-15-months-of-age-100569411","NCT06693895","A Study on the Safety of an Investigational Chickenpox Vaccine, When Given to Healthy Children, 12 to 15 Months of Age","A Phase 3a, Observer-blind, Randomized, Controlled Study to Evaluate the Safety of an Investigational Varicella Vaccine Compared With Varivax, Administered as a First Dose to Healthy Children 12 to 15 Months of Age","Inclusion Criteria:\n\n* Participant's parent(s)\u002FLegally acceptable representatives (LAR\\[s\\]), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiaries, return for follow-up visits).\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 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 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 (no laboratory testing required).\n* Hypersensitivity to latex.\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 dose of study interventions administration (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 dose and 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 time during the study and administered at a different location than the study interventions. Any other age-appropriate vaccine may be given starting at Visit 2 and anytime thereafter.\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    * 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    * Administration of immunoglobulins and\u002For any blood products or plasma derivatives.\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 vaccines, e.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  * Immunocompromised individuals.\n  * Pregnant women without documented history of varicella.\n  * Newborn infants of mothers without documented history of varicella.\n  * Newborn infants born less than (\\\u003C) 28 weeks of gestation.",{"count":99,"type":22},750,[25],"The purpose of this study is to assess how well-tolerated GSK's investigational varicella vaccine (VNS Vaccine) is, in comparison to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted on healthy children aged 12 to 15 months, and who have neither contracted varicella nor received a varicella vaccination.",[28],[28,61],{"date":38,"type":39},{"date":106,"type":39},"2024-11-26",{"date":108,"type":22},"2026-11-23",{"name":45,"class":46},46]