[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100072141":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":30,"locations":35,"responsibleParty":68,"collaborators":71,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":26,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":30,"enrollmentInfo":84,"targetDuration":30,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":30,"overallStatus":93,"whyStopped":30,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"MedImmune LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cold-adapted influenza vaccine trivalent (CAIV-T)","EXPERIMENTAL","A single 0.2 mL dose of 10\\^7 fluorescent focus units was administered intranasally.",[13],"Biological: Cold-adapted influenza vaccine trivalent (CAIV-T)",{"label":15,"type":16,"description":17,"interventionNames":18},"Trivalent Inactivated Vaccine (TIV)","ACTIVE_COMPARATOR","A single dose was administered by intramuscular injection.",[19],"Biological: Trivalent Inactivated Vaccine (TIV)",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Liquid CAIV-T vaccine for this study consisted of 3 cold-adapted, attenuated, reassortant strains, representing the HA and NA antigens of the A\u002FNew Caledonia\u002F20\u002F99 (H1N1), A\u002FPanama\u002F2007\u002F99 (H3N2), and B\u002FVictoria\u002F504\u002F2000 influenza strains. The vaccine contained no preservatives and had a pH of 7.2 ± 0.5.",[9],[26],"FluMist",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Commercially available TIV, inactivated influenza vaccine (Split Virion) BP (Aventis Pasteur MSD, Lyon, France) was administered IM according to the manufacturer's dosing instructions (one 0.5-mL IM dose for adults).",[15],null,[32],{"name":33,"affiliation":5,"role":34},"Robert Walker, MD","STUDY_DIRECTOR",[36,48,52,60],{"facility":37,"status":30,"city":38,"state":39,"zip":30,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":30},"Docnor House","Durban North","Dwazulu Natal","South Africa","ZA",{"type":43,"coordinates":44},"Point",[45,46],31.02367,-29.80252,{"lat":46,"lon":45},{"facility":49,"status":30,"city":50,"state":51,"zip":30,"country":40,"countryCode":41,"cosmosGeoPoint":30,"geoPoint":30,"contacts":30},"Hazelmed Family Practice","Hazelwood","Pretoria",{"facility":53,"status":30,"city":54,"state":30,"zip":30,"country":40,"countryCode":41,"cosmosGeoPoint":55,"geoPoint":59,"contacts":30},"Jansen van Rensburg","eManzimtoti",{"type":43,"coordinates":56},[57,58],30.88527,-30.05219,{"lat":58,"lon":57},{"facility":61,"status":30,"city":62,"state":30,"zip":30,"country":40,"countryCode":41,"cosmosGeoPoint":63,"geoPoint":67,"contacts":30},"Christiaan Tertius de Villiers","Scottburgh South",{"type":43,"coordinates":64},[65,66],30.74386,-30.30331,{"lat":66,"lon":65},{"type":30,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":69,"oldOrganization":70},"Raburn Mallory, MD\u002F Sr Dir Clinical Development","MedImmune",[72],{"name":73,"class":6},"Wyeth is now a wholly owned subsidiary of Pfizer","100072141","phase-3-trial-to-compare-the-safety-tolerability-and-efficacy-of-influenza-virus-vaccine-caiv-t-with-inactivated-influenza-vaccine-trivalent-types-a--b-in-adults-aged-60-years-and-older-against-culture-confirmed-influenza-100072141",false,"NCT00192413","Trial to Compare the Safety, Tolerability, and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Inactivated, Influenza Vaccine, Trivalent, Types A & B, in Adults Aged 60 Years and Older Against Culture-confirmed Influenza","A Prospective, Randomized, Open-Label, Controlled Trial to Compare the Safety, Tolerability, and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) With Inactivated, Influenza Vaccine, Trivalent, Types A & B, in Adults Aged 60 Years and Older","Inclusion Criteria:\n\n* who are aged at least 60 years or older at the time of enrollment;\n* who are determined by medical history, physical examination and clinical judgement to be eligible for this study;\n* who have provided written informed consent after the nature of the study has been explained;\n* who will be available for duration of the trial (from enrollment to November 30th, 2003);\n* who can be reached by study staff for the post-vaccination and weekly surveillance contacts \\[telephone, clinic or home visit\\].\n\nExclusion Criteria:\n\n* who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;\n* who are a resident of a nursing home or long-term care facility or other institution receiving skilled or semi-skilled nursing care (refer to Influenza study specific manual). An ambulatory subject who is a resident of a retirement home or village is eligible for the trial;\n* with any signs of renal insufficiency requiring supportive therapy or progressive neurological disease. (Subjects with other stable pre-existing disease, defined as disease not requiring change in therapy or hospitalization within 12 weeks before receipt of study vaccination will be eligible).\n* with evidence of dementia or other severe cognitive impairment based on Mini Mental State Examination (MMSE) scores (refer to Influenza study specific manual);\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 component of the CAIV-T or TIV vaccine;\n* who were administered any live virus vaccine within one month prior to vaccination or expected to receive another live virus vaccine within one month of vaccination in this study;\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 received a dose of influenza treatment (commercial or investigational) one month prior to enrollment. The prophylactic use of influenza antivirals is not permitted.\n* who receive any influenza vaccine in the 6 months prior to enrollment, or intend to receive a non-study influenza vaccine after enrollment;\n* with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results; Note: A pregnant household member is not considered a contraindication to enrollment.",true,"ALL","60 Years",{"count":85,"type":86},3009,"ACTUAL","INTERVENTIONAL",[89],"PHASE3","To demonstrate that the efficacy over a defined surveillance period against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine, in adults aged at least 60 years at enrollment, of a single intranasally (IN) -administered dose of a liquid formulation of influenza virus vaccine,(CAIV-T) is non inferior compared with that of a single dose of commercially available influenza vaccine inactivated (TIV) administered intramuscularly (IM) prior to the anticipated commencement of the influenza season.",[92],"Influenza","COMPLETED","2012-03-13",{"date":96,"type":97},"2012-03-14","ESTIMATED",{"date":99,"type":30},"2002-03",{"date":101,"type":86},"2002-11",{"name":5,"class":6},4]