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Clinical Trial Details (PDF Generation Date :- Sun, 26 Sep 2021 11:45:11 GMT)

CTRI Number CTRI/2010/091/000102 [Registered on: 22/11/2010] - Last Modified On 14/11/2018 Post Graduate Thesis Type of Trial Interventional Type of Study Vaccine Study Design Randomized, Parallel Group, Placebo Controlled Trial Public Title of Study A Phase III Clinical Trial to evaluate the protective efficacy of three doses of Oral Rotavirus Vaccine (ORV) 116E. Scientific Title of A Phase III, Randomized, Double blind, Placebo Controlled Trial to Evaluate the protective efficacy Study of three doses of Oral Rotavirus Vaccine (ORV) 116E, against severe Rotavirus gastroenteritis in infants Secondary IDs if Any Secondary ID Identifier BBIL/ROTA/021 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Nita Bhandari Trial Coordinator (multi-center study) Designation Project Director Affiliation Centre for Health Research and Development, Society For Applied Studies Address 1st Floor, 45 Kalu Sarai Centre for Health Research and Development, Society for Applied Studies,45 Kalu Sarai, First Floor, 45 Kalu Sarai Centre for Health Research and Development, Society for Applied Studies,45 Kalu Sarai, New Delhi DELHI 110 016 India Phone 01146043751 Fax 01126513952 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Krishna Mohan Query) Designation Executive Drector Affiliation International Limited Address 1st floor, Admin block, Bharat Biotech International Limited, Genome valley, Shameerpet 1st floor, Admin block, Bharat Biotech International Limited, Genome valley, Shameerpet 500078 India Phone 04023480567 Fax 04023480560 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr GVJA Harshavardhan Designation Director - Viral Vaccines Affiliation Bharat Biotech International Limited Address Bharat Biotech International Limited, Genome valley, Shameerpet Bharat Biotech

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Hyderabad ANDHRA PRADESH 500078 India Phone 04023480567 Fax 04023480560 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > 1) Department of (DBT), Ministry of Science and Technology, Government of India CGO Complex, Lodhi Road, New Delhi, India 2) Bharat Biotech International Limited (BBIL), Genome Valley, Shameerpet, Hyderabad, Andhra Pradesh, India 3)PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, USA & A-9, Qutab Institutional Area, New Delhi, India Primary Sponsor Primary Sponsor Details Name Bharat Biotech International Limited Address Genome Valley, Shameerpet, Ranga Reddy (District), Hyderabad-500 078. Type of Sponsor Other [Biotech Industry, India] Details of Secondary Name Address Sponsor Not applicable Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Temsunaro Rongsen Centre for Health C-2, Duggal Colony, 01146043751 Chandola Research and Devli Road,-110 062 01146043756 Development, Society New Delhi [email protected] for Applied Studies DELHI Dr. Gagandeep Kang Christian Medical Ida Scudder +91 416 2282052 College Road,-632004 +91 416 228 2486 Vellore [email protected] TAMIL NADU n Dr. Ashish Bavdekar Shirdi Sai Baba Rural Vadu Rural Health +91 20 6603 7342 / +91 Hospital, KEM Hospital Program,- 20 3254 0027 Research Centre Pune +91 20 2612 5603 MAHARASHTRA [email protected], [email protected] Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Ethics Committee, Approved 08/11/2010 No Department of Biotechnology Ethics Review Approved 17/09/2010 No Committee, Society for Applied Studies, Delhi Institutional Ethics Approved 06/10/2010 No Committee, KEM Hospital Research Centre, Pune Institutional Review Approved 28/10/2010 No Board, Christian Medical College, Vellore Western IRB, Seattle, Approved No Date Specified Not Available

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USA Regulatory Clearance Status Date Status from DCGI Approved/Obtained 10/05/2010 Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers prevention of gastroenterities due to rotavirus infection Intervention / Type Name Details Comparator Agent Intervention Oral Rotavirus Vaccine 116E 3 doses of 0.5mL at 4 week (ORV 116E), 10^5.0 FFU of intervals Bharat Biotech International Limited Comparator Agent Placebo 3 doses of 0.5mL at 4 week intervals Inclusion Criteria Inclusion Criteria Age From 36.00 Day(s) Age To 42.00 Day(s) Gender Both Details Inclusion Criteria
1. At least one parent(s) or legally acceptable representative’s consent for participation and are
2. able to understand study procedures
3. Subjects aged 6 to 7 weeks at recruitment
4. No plans to move in the next 24 months
Exclusion Criteria
1. Administration of rotavirus vaccine in the past
2. Presence of any illness requiring hospital referral (temporary exclusion)
3. Known case of immunodeficiency disease, known HIV positive
4. Known case of chronic gastroenteritis disease
5. Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems ‘ill’, investigators suspects neglect)
6. Diarrhea on the day of enrollment (temporary exclusion)
Exclusion Criteria Exclusion Criteria Details 1. Administration of rotavirus vaccine in the past 2. Presence of any illness requiring hospital referral (temporary exclusion) 3. Known case of immunodeficiency disease, known HIV positive 4. Known case of chronic gastroenteritis disease 5. Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems "ill", investigators suspects neglect) 6. Diarrhea on the day of enrollment (temporary exclusion)

Method of Generating Computer generated randomization Random Sequence Method of Pre-numbered or coded identical Containers Concealment Blinding/Masking Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints Efficacy of ORV 116E in comparison to a 14 days following the 3rd dose till the age of 2 placebo against severe rotavirus gastroenteritis years (24 months) + up to 14 days. caused by non vaccine rotavirus will be assessed in all subjects from 14 days following the 3rd dose till the age of 2 years Secondary Outcome Outcome Timepoints Immunogenicity and Viral Shedding Immunogenicity: 4 weeks after the third dose

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Immunogenicity rates to three doses of the ORV Viral shedding: Day 0, 3, 7 after each dose 116E and vaccine virus shedding rates after each of the three doses of the ORV 116E in comparison to a placebo will be ascertained in approximately 150 subjects at each site. Safety of ORV for Serious Adverse Events in Till the age of 2 years (24 months) + up to 14 comparison to a placebo will be assessed in all days the subjects, from day of 1st dose till the age of 2 Safety for adverse events in comparison to a placebo will be assessed in first one third of the enrolled subjects in all the three sites, which will be assessed daily in the 2 week period following each dose of the ORV 116E. Safety of ORV for intussusception events in comparison to a placebo will be assessed, from day of 1st dose till the age of 2

Safety 1)Safety of ORV 116E for immediate Till the age of 2 years (24 months) + up to 14 adverse events and serious adverse events in days comparison to a placebo will be assessed in all the subjects, from day of 1st dose till the age of 2 years (24 months) + up to 14 days. 2)Safety of ORV 116E for adverse events assessed daily in the 2 week period following each dose in comparison to a placebo in first one third of the enrolled subjects in all the three sites 3)Safety of ORV 116E for intussusception events in comparison to a placebo will be assessed in all subjects, from day of 1st dose till the age of 2 years (24 months) + up to 14 days. Target Sample Size Total Sample Size=6800 Sample Size from India=6800 Final Enrollment numbers achieved (Total)=0 Final Enrollment numbers achieved (India)=0 Phase of Trial Phase 3 Date of First 01/02/2011 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=2 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details yet to publish Brief Summary The trial is a phase III randomized, double-blind, placebo-controlled trial with the primary objective of evaluating the efficacy of three doses of ORV 116E, 10^5.0 FFU, against severe rotavirus gastroenteritis, in comparison with a placebo in india. The Clinical Trial is not a global trial. Three administrations of ORV 116E will be co-administered with childhood vaccines (which will include vaccines against diphtheria, pertussis, tetanus, Haemophilus influenzae B and Hepatitis B and OPV) at 6 to 7 weeks, & greater than or equal to 10 weeks and greater than or equal to 14 weeks of age. 6800 subjects will be enrolled in three sites - Delhi, Pune (Maharashtra) and Vellore (Tamil Nadu) and followed up till the age of 2 years (24 months + up to 14 days). Multiple trial sites are included to ensure greater demographic distribution to obtain evidense of cross immunity and quicker recruitment of the necessary number of subjects. The subjects to be included from these sites would be representative of the population of India.

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