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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Tue, 28 Sep 2021 15:39:14 GMT) CTRI Number CTRI/2009/091/001080 [Registered on: 28/06/2010] - Last Modified On Post Graduate Thesis Type of Trial Type of Study Study Design Randomized, Parallel Group, Placebo Controlled Trial Public Title of Study A clinical Trial to study the safety, immunogenicity and tolerability of a tetravalent rotavirus vaccine in Indian infants. Scientific Title of Phase I/II, randomized, double-blind, placebo-controlled, dosage selection (10e5.5 or 10e6.25 FFU Study of each constituent serotype per 0.5 mL) study to evaluate the safety, tolerability, and immunogenicity of a 3-dose series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] administered to healthy Indian infants. Secondary IDs if Any Secondary ID Identifier NCT01061658 ClinicalTrials.gov SBL/BRV-TV/Form1/PhI/2009/0100 Protocol Number SBL/BRV-TV/Form1/PhI/2009/0100 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr. Gagandeep Kang Trial Coordinator (multi-center study) Designation Affiliation Address Department of Gastrointestinal Sciences, Christian Medical College Vellore TAMIL NADU 632004 India Phone 0416-2282052 Fax 0416-2282486 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr. Raman Rao Query) Designation Affiliation Shantha Biotechnics Limited Address VP, R&D, 4th Floor, Vasantha Chambers, Fateh Maidan Road, Basheer Bagh Hyderabad ANDHRA PRADESH 500004 India Phone 040-66301800 Fax 040-23234133 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr. Raman Rao Designation Affiliation Address VP- R&D, 4th Floor, Vasantha Chambers, Fateh Maidan Road, Basheer Bagh Hyderabad page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in ANDHRA PRADESH 500004 India Phone 040-66301800 Fax 040-23234133 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Shantha Biotechnics Limited, 3rd and 4th Floor, Vasantha Chambers, Fateh Maidan Raod, Basheer Bagh, Hyderabad, Andhra Pradesh. India 500004 Primary Sponsor Primary Sponsor Details Name Shantha Biotechnics Limited, Hyderabad Address Type of Sponsor Details of Secondary Name Address Sponsor NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr. Gagandeep Kang Department of Department of 0416-228-2052 Gastrointestinal Gastrointestinal 0416-228-2486 Sciences, Christian Sciences, Christian [email protected] Medical College, Medical College, n Vellore Vellore,-632004 Vellore TAMIL NADU Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Review Approved No Date Specified Not Available Board, Chrsistian Medical College, Vellore. Regulatory Clearance Status Date Status from DCGI Approved/Obtained No Date Specified Health Condition / Health Type Condition Problems Studied Prevention of Rotavirus Gastroenteritis Intervention / Type Name Details Comparator Agent Intervention Live Attenuated Tetravalent Three doses of 0.5 mL each (G1-G4) Bovine-Human administered orally at one of Reassortant Rotavirus Vaccine two dosage levels (10e5.5 or [BRV-TV], 10e6.25 FFU per constituent virus per 0.5 mL) following oral administration of 2.0 mL of antacid at 6, 10 and 14 weeks of age Comparator Agent Placebo [DMEM plus excipients] Three doses of 0.5 mL each administered orally following oral administration of 2.0 mL of antacid solution at 6, 10 and 14 weeks of age. Inclusion Criteria Inclusion Criteria page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Age From Age To Gender Details - Healthy infants 6-8 weeks of age at time of enrollment of either sex; - Born after a gestational period of 36-42 weeks with birth weight more than equal to 2 kgs - Father, mother or other legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF). In case of father, mother or other legally acceptable representative (guardian) being unable to read or write, having had the ICF explained to them in the presence of a study independent witness and the witness having signed the ICF; - Parent or guardian available for the entire period of the study and reachable by study staff for post-vaccination follow-up. Exclusion Criteria Exclusion Criteria Details - History of congenital abdominal disorders, intussusception, or abdominal surgery; - Known or suspected impairment of immunological function; - Known hypersensitivity to any component of the rotavirus vaccine; - Prior receipt of any rotavirus vaccine; - Fever, with axillary temperature more than or equal to 38.1oC (more than or equall to 100.5oF); measured by study staff. - History of known rotavirus disease, chronic diarrhea, or failure to thrive; - Baseline level of ALT or AST >2.5 times the upper limit of normal; - Clinical evidence of active gastrointestinal illness (infants with GERD can participate in the study so long as this condition is well controlled with or without medication); - Receipt of any IM, oral, or IV corticosteroid treatment in the past 30 days (infants on inhaled steroids may be permitted to participate in the study); - Infants residing in a household with an immuno-compromised person (e.g., individuals with a congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin?s disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, organ or bone marrow transplantation, or those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids); - Infants suspected to be HIV, HBV or HCV positive from the available clinical history or born to mothers known to be HIV, HBV or HCV positive. - Prior receipt of a blood transfusion or blood products, including immunoglobulins; - Any infants who cannot be adequately followed for safety by a home visit; - Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. - Parent/s or guardian of subject unable to maintain diary card Method of Generating Permuted block randomization, fixed Random Sequence Method of Pre-numbered or coded identical Containers Concealment Blinding/Masking Participant, Investigator and Outcome Assessor Blinded Primary Outcome Outcome Timepoints ? The frequency, severity, and causality of REs 28 days following each of the three doses of the and other AEs following each dose and across vaccine/placebo all three doses of each dosage of BRV-TV will be determined and compared to REs and AEs reported for infants given placebo, and the routine childhood vaccines. Secondary Outcome Outcome Timepoints ? The Seroconversion rate, Sero-response rate 28 days following each of the three doses of the and the GMT of serum IgA antibody against vaccine/placebo rotavirus after each dose of clinical material at page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in each dosage level will be calculated and compared to placebo and across dosage levels. The frequency and duration of post-vaccination Upto seven days post each dose of shedding of vaccine rotavirus in stool samples vaccine/placebo will be determined by genotype (VP7 and VP4) analysis. Target Sample Size Total Sample Size=90 Sample Size from India= Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Phase 1/ Phase 2 Date of First No Date Specified Enrollment (India) Date of First 14/07/2010 Enrollment (Global) Estimated Duration of Years=0 Trial Months=7 Days=0 Recruitment Status of Open to Recruitment Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary page 4 / 4 Powered by TCPDF (www.tcpdf.org).
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