[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100151983":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":30,"locations":31,"responsibleParty":44,"collaborators":30,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":30,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":30,"maxAge":55,"enrollmentInfo":56,"targetDuration":30,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":67,"whyStopped":30,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Green Signal Biopharma Private Limited","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BCG Vaccine - Intradermal injection","ACTIVE_COMPARATOR","Subjects must be in the age group of 0 - 14 years of age.\n\n2\\. Subject's parent should be able to understand and have to sign the informed consent form after being explained by the investigator. They must be aware of the experimental nature of the therapy, its potential benefits, side effects and risks.\n\n3\\. Ability to comply with the schedule of treatment and follow-up.\n\n4\\. Absence of BCG scar\n\n5\\. Tuberculin negative\n\n6\\. No evidence of any other infection\n\n7\\. No evidence of skin disease\n\nSkin testing with tuberculin is not generally carried out before giving BCG but when performed, those who are found to be positive reactors need not to be immunized",[13],"Biological: BCG Vaccine IP - Serum Institute of India",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","BCG Vaccine IP - Serum Institute of India","0.1 ml for adults and children aged 1 month and over 0.05 ml for infants under 1 month of age",[9],[21],"BCG Vaccine IP (SIIL)",[23,27],{"name":24,"affiliation":25,"role":26},"SR Lakshimipathy, MBBS, DCH","KC General Hospital, Malleswaram, Bangalore","PRINCIPAL_INVESTIGATOR",{"name":28,"affiliation":29,"role":26},"Mohamed Kizhar Irshat, MBBS, DCH","Arya vysya maternity home & child welfare centre",null,[32],{"facility":29,"status":30,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":30},"Chennai","Tamil Nadu","600001","India","IN",{"type":39,"coordinates":40},"Point",[41,42],80.27847,13.08784,{"lat":42,"lon":41},{"type":30,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":45,"oldOrganization":5},"Mr.Sajjanadhasan.VJ","100151983","phase-3-a-study-of-comparing-safety-and-reactogenicity-of-lyophilized-bcg-vaccine-ip-of-green-signal-bio-pharma-private-limited-india-with-bcg-vaccine-of-serum-institute-of-india-limited-in-120-healthy-children-100151983",false,"NCT01250249","A Study of Comparing Safety and Reactogenicity, of Lyophilized BCG Vaccine IP of Green Signal Bio Pharma Private Limited, India With BCG Vaccine of Serum Institute of India Limited in 120 Healthy Children.","A Randomized, Open Label, Single-period, Single-treatment, Controlled Multi Center Phase Iii Study of Comparing Safety and Reactogenecity of Lyophilized BCG Vaccine ip (0.1 mg in 0.1 ml) of Green Signal Bio Pharma Private Limited India With BCG Vaccine (0.1 mg in 0.1 ml) of Serum Institute of India Limited (SIIL),India in 120 Healthy Children.","Inclusion Criteria:\n\n1. Subjects must be in the age group of 0 - 14 years of age.\n2. Subject's parent should be able to understand and have to sign the informed consent form after being explained by the investigator. They must be aware of the experimental nature of the therapy, its potential benefits, side effects and risks.\n3. Ability to comply with the schedule of treatment and follow-up.\n4. Absence of BCG scar\n5. Tuberculin negative\n6. No evidence of any other infection\n7. No evidence of skin disease -\n\nExclusion Criteria:\n\nHistory or presence of significant:\n\nCardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrinal, immunologic, dermatologic, neurological or psychiatric disease.\n\nMore specifically, history or presence of significant:\n\nLow birth weight babies (\\\u003C2.5 Kg),\n\nMalignancy,\n\nTuberculin positive,\n\nHodgkin's disease,\n\nCorticosteroid therapy,\n\nGeneralised Eczema,\n\nInfective dermatosis,\n\nHypogammaglobulinemia,\n\nImmunosuppressed,\n\nAbove 14 years of age,\n\nOn anti-tubercular drugs,\n\nChest X ray evidence of TB.\n\n\\-",true,"ALL","14 Years",{"count":57,"type":58},120,"ACTUAL","INTERVENTIONAL",[61],"PHASE3","To compare Safety and Reactogenecity of BCG vaccine of Green Signal Biopharma Private Limited India with BCG vaccine of serum institute of India limited (SIIL), India in 120 healthy children.",[64],"Healthy",[66],"To compare Safety and Reactogenecity of BCG vaccine of Green Signal Biopharma Private Limited with BCG vaccine of serum institute of India limited","COMPLETED","2010-11-29",{"date":70,"type":71},"2010-11-30","ESTIMATED",{"date":73,"type":30},"2008-11",{"date":75,"type":58},"2009-06",{"name":5,"class":6},1]