[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100180766":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":45,"locations":46,"responsibleParty":80,"collaborators":45,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":45,"eligibilityCriteria":87,"healthyVolunteers":84,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":45,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":105,"whyStopped":45,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cervarix Group","EXPERIMENTAL","Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.",[13],"Biological: Cervarix",{"label":15,"type":16,"description":17,"interventionNames":18},"Priorix + Infanrix Group","ACTIVE_COMPARATOR","Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.",[19,20],"Biological: Priorix","Biological: Infanrix",[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BIOLOGICAL","Cervarix","2 doses administered intramuscularly in the deltoid muscle of the left arm at Day 0 and Month 6.",[9],[28],"HPV",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Priorix","1 dose administered intramuscularly in the deltoid muscle of the left arm at Day 0.",[15],[34],"MMR",{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Infanrix","1 dose administered intramuscularly in the deltoid muscle of the left arm at Month 6.",[15],[40],"DTPa",[42],{"name":43,"affiliation":5,"role":44},"GSK Clinical Trials","STUDY_DIRECTOR",null,[47,59,61,71],{"facility":48,"status":45,"city":49,"state":45,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":45},"GSK Investigational Site","Bogotá","38007","Colombia","CO",{"type":54,"coordinates":55},"Point",[56,57],-74.08175,4.60971,{"lat":57,"lon":56},{"facility":48,"status":45,"city":60,"state":45,"zip":45,"country":51,"countryCode":52,"cosmosGeoPoint":45,"geoPoint":45,"contacts":45},"Yopal, Casanare",{"facility":48,"status":45,"city":62,"state":45,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":70,"contacts":45},"México","04530","Mexico","MX",{"type":54,"coordinates":67},[68,69],-108.15213,31.00435,{"lat":69,"lon":68},{"facility":48,"status":45,"city":72,"state":45,"zip":45,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":79,"contacts":45},"Panama City","Panama","PA",{"type":54,"coordinates":76},[77,78],-79.51973,8.9936,{"lat":78,"lon":77},{"type":81,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100180766","phase-3-safety-and-immunogenicity-of-gsk-biologicals-hpv-1618-l1-vlp-as04-vaccine-gsk-580299-in-healthy-female-children-4-6-years-old-100180766",true,"NCT01627561","Safety and Immunogenicity of GSK Biologicals' HPV-16\u002F18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old","Inclusion Criteria:\n\n* Subjects who the investigator believes that parent(s)\u002FLegally Acceptable Representative(s) \\[LAR(s)\\] can and will comply with the requirements of the protocol.\n* A female between, and including, 4 and 6 years of age at the time of the first vaccination.\n* Written informed consent obtained from the parent(s)\u002FLAR(s) of the subject prior to enrolment in the study.\n* Healthy subjects as established by medical history and clinical examination before entering into the study.\n* Subjects who received four doses of DTP vaccine (i.e., three doses in the first year of life and a fourth dose in the second year of life) according to the schedule applicable in the participating countries.\n* Subjects who received a first dose of MMR vaccine according to the schedule applicable in the participating countries.\n\nExclusion Criteria:\n\n* Child in care.\n* Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen in the protocol.\n* Planned administration\u002Fadministration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine(s). Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza and\u002For poliomyelitis vaccines up to 8 days before the first dose of study vaccine(s) is allowed. Enrolment will be deferred until the subject is outside of specified window.\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine(s), or planned use during the study period.\n* History of any reactions or hypersensitivity likely to be exacerbated by any component of the study vaccines, including latex and\u002For obvious allergic reactions to neomycin (a history of contact dermatitis to neomycin is not a contraindication), egg protein, etc. (e.g. hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock subsequent to egg ingestion).\n* Cancer or autoimmune disease under treatment.\n* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).\n* Previous administration of MPL or AS04 adjuvant.\n* Administration of immunoglobulins and\u002For any blood products within the three months preceding the first dose of study vaccine(s) or planned administration during the study period.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).\n* Family history of congenital or hereditary immunodeficiency.\n* Documented human immunodeficiency virus (HIV)-positive subject.\n* Major congenital defects or serious chronic illness.\n* History of seizures or serious neurological disorder, which, according to the judgment of the investigator, precludes administration of any of the study vaccines.\n* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine(s).\n* Acute disease and\u002For fever at the time of enrolment.\n\n  * Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0°C on rectal setting.\n  * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. Enrolment can be deferred until condition is resolved.\n* Previous administration of the fifth dose of DTP vaccine and\u002For the second dose of MMR vaccine or planned administration of DTP vaccine and\u002For MMR vaccine outside the study (during the study period from Day 0 to Month 12).\n* History of tetanus, diphtheria, pertussis, measles, mumps and\u002For rubella.\n* Known exposure to diphtheria or household exposure to pertussis within 30 days prior to vaccination with DTPa.\n* Known exposure to measles, mumps and\u002For rubella 30 days prior to vaccination with the MMR study vaccine.\n* Confirmed or suspected tuberculosis.\n* Severe allergic reactions (e.g. anaphylaxis or severe Arthus-type hypersensitivity reactions) following the administration of previous dose(s) of DTP or MMR vaccines.\n* Hyperpyrexia (≥ 40.5°C) within 48 hours of administration of previous doses of DTP or MMR vaccines.\n* Persistent, inconsolable crying lasting more than 3 hours, occurring within 48 hours of administration of previous doses of DTP vaccine.\n* Collapse or shocking-like state (hypotonic-hyporesponsive episode) within 48 hours of administration of previous doses of DTP vaccine.\n* Idiopathic thrombocytopenic purpura or bleeding disorders.\n* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose(s). (For corticosteroids, this will mean prednisone ≥ 0.5 mg\u002Fkg\u002Fday, or equivalent. Inhaled and topical steroids are allowed.)","FEMALE","4 Years","6 Years",{"count":92,"type":93},148,"ACTUAL","INTERVENTIONAL",[96],"PHASE3","The current study evaluates the immunogenicity and safety in 4-6 years old female subjects (experimental group) receiving Cervarix according to a 2-dose schedule (Month 0, 6), as compared to 4-6 years old female subjects (control group) receiving sequentially Priorix (Month 0) and Infanrix (Month 6) vaccines.",[99],"Infections, Papillomavirus",[101,102,103,104],"Immune response","Human papillomavirus","HPV vaccine","Safety","COMPLETED","2020-03-19",{"date":108,"type":93},"2020-04-10",{"date":110,"type":93},"2012-10-15",{"date":112,"type":93},"2016-10-06",{"name":5,"class":6},4]