[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100222786":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":52,"centralContacts":43,"locations":43,"responsibleParty":56,"collaborators":43,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":43,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":43,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":84,"whyStopped":85,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":43},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",[8,14,18,22,26,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Formulation 1 Group","EXPERIMENTAL","Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 1 at a 21 day interval",[13],"Biological: Investigational H7N9 vaccine GSK3277510A",{"label":15,"type":10,"description":16,"interventionNames":17},"Formulation 2 Group","Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 2 at a 21 day interval",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Formulation 3 Group","Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 3 at a 21 day interval",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Formulation 4 Group","Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 4 at a 21 day interval",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Formulation 5 Group","Subjects in this group will receive two doses of GSK3277509A H7N9 vaccine formulation 5 at a 21 day interval",[30],"Biological: Investigational H7N9 vaccine GSK3277509A",{"label":32,"type":33,"description":34,"interventionNames":35},"Placebo Group","PLACEBO_COMPARATOR","Subjects in this group will receive two doses of placebo at a 21 day interval",[36],"Biological: Placebo",[38,44,48],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"BIOLOGICAL","Investigational H7N9 vaccine GSK3277510A","One dose of GSK3277510A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277510A H7N9 vaccine administered IM in the deltoid region of dominant arm at Day 21",[9,15,19,23],null,{"type":39,"name":45,"description":46,"armGroupLabels":47,"otherNames":43},"Investigational H7N9 vaccine GSK3277509A","One dose of GSK3277509A H7N9 vaccine administered IM at the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277509A H7N9 vaccine administered IM at the deltoid region of dominant arm at Day 21",[27],{"type":39,"name":49,"description":50,"armGroupLabels":51,"otherNames":43},"Placebo","One dose of placebo administered IM at the deltoid region of non-dominant arm at Day 0 and the second dose of placebo administered IM at the deltoid region of dominant arm at Day 21",[32],[53],{"name":54,"affiliation":5,"role":55},"GSK Clinical Trials","STUDY_DIRECTOR",{"type":57,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100222786","phase-1-immunogenicity-and-safety-study-of-glaxosmithkline-gsk-biologicals-influenza-vaccines-gsk3277510a-and-gsk3277509a-in-adults-18-to-60-years-of-age-100222786",false,"NCT02177734","Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine(s) GSK3277510A and GSK3277509A in Adults 18 to 60 Years of Age","An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine(s) GSK3277510A and GSK3277509A Administered in Adults 18 to 60 Years of Age","Inclusion Criteria:\n\n* Male or female adults who are 18 to 60years of age (inclusive) at the time of first study vaccination.\n* Written informed consent obtained from subject.\n* Subjects who the investigator believes can and will comply with the requirements of the protocol.\n* Healthy subjects as established by medical history and physical examination.\n* Access to a consistent means of telephone contact.\n* For subjects who undergo a screening visit: Results of screening safety laboratory tests that figure in eligibility assessment must be within reference ranges before dosing.\n* Female subjects of non-childbearing potential may be enrolled in the study.\n* Female subjects of childbearing potential may be enrolled in the study, if they\n\n  * have practiced adequate contraception for 30 days prior to vaccination, and\n  * have a negative pregnancy test on the day of vaccination, and agree to continue to practice adequate contraception until 2 months after the last dose administered.\n\nExclusion Criteria:\n\n* Presence or evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable\u002Funlikely to provide accurate safety reports.\n* Presence or evidence of substance abuse.\n* Diagnosed with cancer, or treatment for cancer within three years.\n* Diagnosed with excessive daytime sleepiness, or narcolepsy; or history of narcolepsy in a subject's parent, sibling or child.\n* Presence of a temperature ≥ 38.0ºC (≥100.4ºF), or acute symptoms greater than \"mild\" severity on the scheduled date of first vaccination.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.\n* Receipt of systemic glucocorticoids within 30 days prior to the first dose of study vaccine\u002Fplacebo, or any other cytotoxic, immunosuppressive or immune-modifying drugs within 6 months of first study vaccine\u002F placebo dose.\n* Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.\n* An acute evolving neurological disorder or Guillain Barré Syndrome within 42 days of receipt of prior seasonal or pandemic influenza vaccine.\n* Administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days before the first dose of study vaccine\u002Fplacebo.\n* Planned administration of any vaccine other than the study vaccine\u002Fplacebo before blood sampling at the Day 42 visit.\n* Previous administration of any H7 vaccine or physician-confirmed H7 disease.\n* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine\u002Fplacebo, or planned use during the study period.\n* Receipt of any immunoglobulins and\u002For any blood products within 90 days before the first dose of study vaccine\u002Fplacebo, or planned administration of any of these products during the study period.\n* Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine including a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.\n* Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result before the first dose of study vaccine\u002Fplacebo.\n* Lactating or nursing women.\n* Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.",true,"ALL","18 Years","60 Years",{"count":70,"type":71},0,"ACTUAL","INTERVENTIONAL",[74],"PHASE1","The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 60 years of age.",[77],"Influenza",[79,80,77,81,82,83],"Adjuvant","Safety","H7N9","Immunogenicity","Adults","WITHDRAWN","The study was cancelled for scientifically legitimate reasons not related to safety or efficacy of the vaccine.","2016-06-16",{"date":88,"type":89},"2016-06-20","ESTIMATED",{"date":91,"type":43},"2016-03",{"date":93,"type":89},"2017-05",{"name":5,"class":6}]