[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100072123":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":25,"locations":33,"responsibleParty":91,"collaborators":94,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":105,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":25,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":25,"overallStatus":118,"whyStopped":25,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"MedImmune LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CAIV-T","EXPERIMENTAL","The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).",[13],"Biological: Cold-adapted influenza vaccine trivalent (CAIV-T)",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Biological: Placebo",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Cold-adapted influenza vaccine trivalent (CAIV-T)","The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 ml into each nostril). Each dose of CAIV-T used in this study contained approximately 10\\^7+\u002F-0.5 fluorescent focus units (FFU) (equivalent to 10\\^7+\u002F-0.5 TCID50) of each of the following three influenza virus strains: Influenza Cold Adapted Virus Type H1N1, strain A\u002FNew Caledonia\u002F20\u002F99; Influenza Cold Adapted Virus Type H3N2, strain A\u002F Panama\u002F2007\u002F99; Influenza Cold Adapted Virus Type B, strain B\u002FHong Kong\u002F 330\u002F01.",[9],null,{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"The placebo consisted of physiologic normal saline.",[15],[30],{"name":31,"affiliation":5,"role":32},"Raburn Mallory, M.D.","STUDY_DIRECTOR",[34,45,53,61,71,82],{"facility":35,"status":25,"city":36,"state":25,"zip":25,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":25},"Catholic University Leuven","Leuven","Belgium","BE",{"type":40,"coordinates":41},"Point",[42,43],4.70093,50.87959,{"lat":43,"lon":42},{"facility":46,"status":25,"city":47,"state":25,"zip":25,"country":37,"countryCode":38,"cosmosGeoPoint":48,"geoPoint":52,"contacts":25},"Zamenhoflaan 12","Schoten",{"type":40,"coordinates":49},[50,51],4.50268,51.25251,{"lat":51,"lon":50},{"facility":54,"status":25,"city":55,"state":25,"zip":25,"country":37,"countryCode":38,"cosmosGeoPoint":56,"geoPoint":60,"contacts":25},"Universiteit Antwerpen","Wilrijk",{"type":40,"coordinates":57},[58,59],4.39513,51.16734,{"lat":59,"lon":58},{"facility":62,"status":25,"city":63,"state":25,"zip":25,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":70,"contacts":25},"Oddzial Dzieciecy Szpitala Powiatowete im","Trzebnica","Poland","PL",{"type":40,"coordinates":67},[68,69],17.06331,51.31076,{"lat":69,"lon":68},{"facility":72,"status":25,"city":73,"state":25,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":25},"The Gables Medicentre","Coventry","CV 6 4DD","United Kingdom","UK",{"type":40,"coordinates":78},[79,80],-1.51217,52.40656,{"lat":80,"lon":79},{"facility":83,"status":25,"city":84,"state":25,"zip":85,"country":75,"countryCode":76,"cosmosGeoPoint":86,"geoPoint":90,"contacts":25},"Townhead Surgery","Irvine, Ayshire","KA 12 OAY",{"type":40,"coordinates":87},[88,89],-4.65508,55.6194,{"lat":89,"lon":88},{"type":25,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":92,"oldOrganization":93},"Raburn Mallory, MD\u002F Sr Dir Clinical Development","MedImmune",[95],{"name":96,"class":6},"Wyeth is now a wholly owned subsidiary of Pfizer","100072123","phase-2-a-phase-ii-trial-to-assess-the-safety-and-tolerability-of-influenza-virus-vaccine-caiv-t-in-healthy-children-and-adolescents-ages-6-to-less-than-18-years-100072123",false,"NCT00192179","A Phase II, Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine, CAIV-T in Healthy Children and Adolescents Ages 6 to Less Than 18 Years.","A Phase II, Prospective, Randomized, Double-Blind, Placebo, Controlled Trial, to Assess the Safety and Tolerability of Influenza Virus Vaccine, Trivalent, Types A & B Live Cold-Adapted Liquid Formulation (CAIV-T) in Healthy Children and Adolescents Ages 6 to Less Than 18 Years.","FluMist","Inclusion Criteria:\n\n* who are aged 6 to less than 18 years at the time of enrolment\n* who, if female and is of child bearing potential is using reliable method of hormonal and\u002For non-hormonal contraception (which includes cervical cap, diaphragm, condoms, with spermicide or IUD) during sexual intercourse throughout the entire study period; has provided a negative pregnancy test (with detection limit of less than or equal to 25mL\u002Fml) no more than 24 hours prior to the study vaccine administration and agreed to avoid pregnancy during participation in the study.\n\nN.B.lactating females are excluded from the study.\n\n* who are in good health as determined by medical history, physical examination and clinical judgement\n* whose parent(s)\u002Flegal guardian(s) have provided written informed consent after the nature of the study has been explained\n* who, along with their parent(s)\u002Flegal guardian(s) will be available until completion of the study\n* whose parent(s)\u002Flegal guardian(s), can be reached by study staff for the post vaccination contacts(telephone, clinic or home visit)\n\nExclusion Criteria:\n\n* who along with their parent(s)\u002Flegal guardian(s) are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period\n* with any serious chronic disease (e.g. with signs of cardiac or renal failure or severe malnutrition) including progressive neurological disease\n* with Down's syndrome or other known cytogenetic disorders\n* with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents\n* who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study\n* have an immunosuppressed or an immunocompromised individual living in the same household\n* with a documented history of hypersensitivity to egg or egg protein or any other components of CAIV-T or placebo\n* who have a history of Guillain-Barre Syndrome (GBS)\n* for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study\n* who, in the two weeks prior to entry into the study, received a dose of influenza treatment (commercial or investigational)\n* who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use is anticipated during the study\n* who, at anytime prior to study enrollment, received any influenza vaccine (commercial or investigational)\n* with asthma requiring regular medical follow up or hospitalization during the preceding year\n* with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results\n* Note: Pregnancy in any person who has regular contact with the subjects is not a contraindication to enrollment or ongoing participation of the subject in the study.",true,"ALL","6 Years","17 Years",{"count":110,"type":111},240,"ACTUAL","INTERVENTIONAL",[114],"PHASE2","A safety study to compare, over a 7 day period, the fever rates following one dose of either Influenza Virus Vaccine or placebo administered outside the influenza season to healthy children and adolescents aged 6 to less than 18 years.",[117],"Influenza","COMPLETED","2012-02-29",{"date":121,"type":122},"2012-03-02","ESTIMATED",{"date":124,"type":25},"2003-06",{"date":126,"type":111},"2003-07",{"name":5,"class":6},6]