Clinical Trial Details (PDF Generation Date :- Fri, 07 Dec 2018 19:05:34 GMT) CTRI Number CTRI/2009/091/000669 [Registered on: 01/12/2009] - Last Modified On Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study Single Arm Trial A Post Marketing Surveillance study of BCG vaccine in n population A Multicentre, Open label, Prospective, Single treatment, Single dose, Post Marketing Surveillance study to evaluate the safety and tolerability of Lyophilized BCG vaccine IP of Green Signal BioPharma Pvt. Ltd,,. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) NIL NIL Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Source of Monetary or Material Support > Green Signal BioPharma Pvt. Ltd.,, Type of Sponsor Azidus Laboratories Ltd,, List of Countries of Principal Investigator Dr. Jayakodi Muralidharan Dr. A. Parthasarathi Dr. S. Ramani Primary Sponsor Details Green Signal BioPharma Pvt. Ltd.,, of Site Site Phone/Fax/ Dangoria Maternity and Nursing Home Ganga Medical Centre & Hospitals Ganga Medical Centre & Hospitals RTC?X? Road, Musheerabad Road,-500020 Hyderabad ANDHRA PRADESH Swarnambica Layout,-641109 Swarnambica Layout,-641109 Dr. Veena.V HSIS Gosha Hospital Shivaji Nagar, Bangalore,-560051 Bangalore KARNATAKA Dr. Lakshmipathy KC general Hospital 3rd Cross Street, Near Malleswaram Police Station, Malleswaram,-560051 Bangalore KARNATAKA Dr V Rathikka Ranga hospital 1638, Thadagam road, velandipalayam,-64102 5 Not Applicable N/A Dr Jayavardhanam Saraswathi Hospital 152 A, 153, Trichy Road, Chinthamani Pudur,-641103 Dr. Subash Mohan Dass Dr.Ashok D. Rathod Sheela Hospital Sir. J.J. group of Govt. Hospitals 46/117, East Power House Road,-600012 Not Applicable N/A Byculla,-400008 Mumbai 040-27646286 9884286370 9443935557 9448512311 drveenavenkat@gmail. com 9845932154 lakshmipathysr@gmail. com 9443029126 9944469902 9842119020 page 2 / 5
Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Dr. Mohammed Khizar Irshath The Arya vysya Maternity Home & Child Welfare Centre MAHARASHTRA 174, Govindappa Naick Street,-600001 9444114664 of Committee Approval Status Date of Approval Is Independent Ethics Committee? IEC, Grant Medical College & Sir JJ group of hospitals, Mumbai Status Approved/Obtained Health Type Date No Date Specified Condition Type Details Children will be given the BCG vaccine which is already approved by DCGI and available in market and a surveillance will be done about the tolerability of the vaccine. Intervention vaccination single dose Comparator Agent Nil Nil Age From Age To Gender Details Inclusion Criteria * Male and female new born babies with the age of less than one month - Healthy babies as evaluated by personal & medical history, general and systemic examination - Babies with the body weight of more than 2 kgs - Babies having minimum 34 weeks of intrauterine gestational period - Mother being negative to HIV 1 & 2, Hepatitis B & C * Male and female infants with the age of one month, but less than one year - Healthy babies as evaluated by personal & medical history, general and systemic examination - Babies with the body weight proportionate to the age and judged to be acceptable in view of the physician - Mother being negative to HIV 1 & 2, Hepatitis B & C * Male and female children with the age of 1 to 14 yrs - Healthy page 3 / 5
Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details children as evaluated by personal & medical history, general and systemic examination - Children being negative for Tuberculin test - Normal Hematological and urinary parameters and chest X ray (or Clinically insignificant deviations in view of the physician) - Negative for HIV 1 & 2, Hepatitis B & C * Apart from the age specific inclusion criteria, the following criteria are generally applicable - Parents willing to give informed consent and comply with study requirements - Absence of BCG vaccine scar - In the best interest of the child?s health, the physician may recruit any potential subject who is otherwise likely to get rejected from vaccination. Exclusion Criteria * Male and female new born babies with the age of less than one year - Babies with prolonged umbilical cord bleeding (only for babies upto one month old) - Parents having tuberculosis * Male and female children with the age of 1 to 14 yrs - Positive Tuberculin test - Positive for HIV 1 & 2, Hepatitis B & C - Abnormal hematological & urinary parameters and / or chest X ray * Apart from the age specific exclusion criteria, the following are applicable generally - Babies considered to be very sick (in view of the physician) - Having localized or systemic infections - History suggestive of or Diagnosed of having Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrinal, immunological, dermatological, neurological or psychiatric disorders - Subjects having acute or chronic febrile conditions - Receiving immunosuppressants including corticosteroids and anti tubercular drugs - Hypersensitivity reaction to the vaccine - In the best interest of the child?s health, the physician may reject any potential subject who is otherwise eligible for vaccination. Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints Safety and tolerability at 30 minutes, 3rd day and during 6th week after vaccination Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 4 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Assessment of vaccination site wound healing Total Sample Size=1000 Sample Size from = No Date Specified 04/10/2009 Years=0 Months=6 Days=0 Open to Recruitment at 30 minutes, 3rd day and during 6th week after vaccination The study is a surveillance to be conducted across. There are no predetermined sites. page 4 / 5
Powered by TCPDF (www.tcpdf.org) PDF of Trial However the sites and physicians to be part of the surveillance as on 02/09/09 are given above. page 5 / 5