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CTRI Number  CTRI/2014/08/004893 [Registered on: 20/08/2014] Trial Registered Prospectively
Last Modified On: 30/04/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to evaluate immune non-inferiority and safety of Tetravalent Rotavirus Vaccine (BRV-TV) in comparison to licensed vaccine (RotaTeq) in healthy infants. 
Scientific Title of Study   A phase III study to evaluate immune non inferiority and safety of the All in One liquid formulation of a live attenuated tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV) to a licensed vaccine RotaTeq when administered as three dose series to Indian infants concomitantly with other routinely recommended vaccines for the age. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BRV07 Version 1.0 dated 21st February 2014  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Tarun Saluja MD  
Designation  AGM, Clinical R&D 
Affiliation  Shantha Biotechnics Limited 
Address  3rd and 4th Floor, Vasantha Chambers,#5-10-173, Fateh Maidan Road, Basheer Bagh

Hyderabad
ANDHRA PRADESH
500004
India 
Phone  40-66301000  
Fax  40-23234133  
Email  Tarun.Saluja@sanofi.com  
 
Details of Contact Person
Public Query  
Name  Dr Mandeep Singh Dhingra MD 
Designation  Chief Clinical, PV and CQA Officer 
Affiliation  Shantha Biotechnics Limited 
Address  3rd and 4th Floor, Vasantha Chambers,#5-10-173, Fateh Maidan Road, Basheer Bagh

Hyderabad
ANDHRA PRADESH
500004
India 
Phone  40-66301000  
Fax  40-23234133  
Email  MandeepSingh.Dhingra@sanofi.com  
 
Source of Monetary or Material Support  
Shantha Biotechnics Limited 
 
Primary Sponsor  
Name  Shantha Biotechnics Limited 
Address  3rd and 4th Floor, Vasantha Chambers, #5-10-173, Fateh Maidan Road, Basheer Bagh, Hyderabad. 500004. AP, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Puneet Mishra  All India Institute of Medical Sciences  Department of Community Medicine, All India Institute of Medical Sciences New Delhi-110029
New Delhi
DELHI 		 011-26593773

doctormisra@gmail.com 
Dr Sonali Hemant Palkar  Bharati Vidyapeeth Deemed University Medical College and Hospital  Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune-411043
Pune
MAHARASHTRA 		 020-24364308

palkarsh@gmail.com 
Dr Sharad Agarkhedkar  Dr. D. Y. Patil Medical College & Research Center  Department of Pediatrics, Dr. D. Y. Patil Medical College & Research Center, Pune-411018
Pune
MAHARASHTRA 		 020-27423693

ashalaka@gmail.com 
Dr Avinash Shetty  Dr.TMA Pai Rotary Hospital  Department of Community Medicine,Dr. TMA Pai Rotary Hospital, Karkala-574104
Udupi
KARNATAKA 		 08258-235483

avinash.shetty@manipal.edu 
Dr Ashwani Kumar Sood  Indira Gandhi Medical college   Department of Pediatrics, Indira Gandhi Medical college Shimla-171001
Shimla
HIMACHAL PRADESH 		 0177-2651616

doc.aksood@gmail.com 
Dr S M Dhaded  J .N. Medical College   Department of Pediatrics, J .N. Medical College Belgaum-590010
Belgaum
KARNATAKA 		 831-2472777

drdhadedsm@gmail.com 
Dr M D Ravi  JSS Hospital   Department of Pediatrics, JSS Hospital Mysore-570 004
Mysore
KARNATAKA 		 0821-2548363

ravimdped@yahoo.co.in 
Dr S Balsubramanian  Kanchi Kamakoti Childs Hospital Trust   Department of Pediatrics, Kanchi Kamakoti Childs Hospital Trust Chennai-600034
Chennai
TAMIL NADU 		 044-42001844

sbsped@gmail.com 
Dr P Venugopal  King George Hospital  Department of Pediatrics King George Hospital Visakhapatnam-530002
Visakhapatnam
ANDHRA PRADESH 		 0891-2727203

venugopal_kgh@yahoo.com 
Dr Amlan Choudhury  KPC Medical college & Hospital  Department of Pediatrics, KPC Medical college & Hospital,Kolkata-700032
Kolkata
WEST BENGAL 		 33-66211700

pedamlan1@gmail.com 
Dr Madhu Gupta  Post Graduate Institute of Medical Education & Research  Dept. of Community Medicine, School of Public Health, PGIMER, Chandigarh-160012
Chandigarh
CHANDIGARH 		 0172-2755223

madhugupta21@gmail.com 
Dr Ramesh Kumar  Pt.B.D. Sharma, PGIMS   Department of Community Medicine, Pt.B.D. Sharma PGIMS Rohtak-124001
Rohtak
HARYANA 		 0126-2210057

drrameshverma69@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
AIIMS Institute of Ethics Committee, New Delhi- 110029  Approved 
Ethics Committee Dr. DY Patil Vidyapeeth,Pune- 411018  Approved 
Institutional Ethics Committee Bharati Vidyapeeth Deemed University,Pune-411030  Approved 
Institutional Ethics Committee Indira Gandhi Medical college,Shimla-171001  Approved 
Institutional Ethics Committee JSS Medical College,Mysore-570015  Approved 
Institutional Ethics Committee Kasturba Medical College, Manipal-576104  Approved 
Institutional Ethics Committee King George Hospital, Visakhapatnam-530002  Approved 
Institutional Ethics Committee KPC Medical college & Hospital,Kolkata-700032  Approved 
Institutional Ethics Committee Pt. B.D Sharma PGIMS,Rohtak-124001  Approved 
Institutional Review Board & Ethics committee of Kanchi Kamakoti,CHILD Trust Hospital & The CHILD Trust medical Research Foundation, Chennai-600034  Approved 
KLE University Ethics Committee,Belgaum- 590 010  Approved 
PGIMER Institutional Ethics Committee, Chandigarh-160012  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Vaccine for prevention of Rotavirus Gastroenteritis  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BRV-TV  Investigational Study Vaccine (BRV-TV) — Each 2.0 mL dose administered orally as 3 dose series at 6-8 ,10-12 and 14-16 weeks of age.  
Comparator Agent  RotaTeq  Comparator stusy vaccine (RotaTeq) — Each 2.0 mL dose administered orally as 3 dose series at 6-8 ,10-12 and 14-16 weeks of age. 
 
Inclusion Criteria  
Age From  42.00 Day(s)
Age To  56.00 Day(s)
Gender  Both 
Details  All infants must fulfill all of the following criteria in order to be eligible for the trial enrollment
• Healthy infants, of either sex, 6-8 weeks of age at time of enrollment;
• Born after a gestational period of ≥36 weeks with birth weight ≥ 2 kg;
• 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 the ICF explained to them in the presence of an impartial witness and the witness having signed the ICF.
• Infant, parent or guardian available for the entire period of the study and reachable by study staff for post-vaccination follow-up.
 
 
ExclusionCriteria 
Details  Any infant fulfilling any of the following criteria is to be excluded from the trial enrollment
• History of congenital abdominal disorders, intussusception, or abdominal surgery;
• Infants exhibiting signs of severe malnutrition;
• Known or suspected impairment of immunological function in subject or immediate family;
• Developmental delay or Neurological disorder;
• Known hypersensitivity to any component of the study vaccines or any history of allergic reaction in past;
• Prior receipt of any rotavirus vaccine;
• Prior receipt of any dose of Diphtheria, Tetanus, Pertussis, Hepatitis B, Hib or polio virus containing vaccine(s). Birth dose of Hepatitis B,BCG and Oral Polio Vaccine is allowed to be administered to the infants as per the local immunization practices. Oral Polio Vaccines administered as a part of the National Pulse Polio Program are allowed to be administered to the infants.
• History of known rotavirus disease, chronic diarrhea, or failure to thrive;
• Clinical evidence of active gastrointestinal illness including ongoing diarrheal episode (infants with GERD can participate in the study as long as the 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 already laboratory confirmed or 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 (no specific screening for the purpose of the study would be carried out);
• Prior receipt of a blood transfusion or blood products, including immunoglobulins, in the past 4 weeks which might interfere with the assessment of the immune response;
• 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 infant unable to maintain symptom diary or note the AEs and temperature in native language for subsequent transfer into symptom diary with help of the site study team;
• Participation in another clinical trial investigating a vaccine, drug, medical device or medicinal procedure in the 4 weeks preceding the trial vaccination;
• Planned participation in another clinical trial during the present trial period;
• Parents/ Guardians/ Legally Accepted Representatives identified as employees of the investigator, with direct involvement in the proposed study or studies under the direction of that investigator as well as children, adopted or natural, of the employees or Investigator.
• Parents/ Guardians/ Legally Accepted Representatives unwilling to provide consent for Audio Visual recording of the informed consent process.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Sero-response rate of Investigational Rotavirus vaccine/ RotaTeq  28 days post 3rd dose of vaccination 
 
Secondary Outcome  
Outcome  TimePoints 
• Frequency, severity, and causality of REs and other AEs following the dose of Investigational Rotavirus Vaccine /RotaTeq.
• Describe the serum anti-rotavirus neutralizing antibody titres of BRV-TV/RotaTeq
• Demonstrate the non-inferiority of the seroprotection/ seroresponse levels of the Ig antibodies against Diphtheria, Tetanus, Pertussis, Hepatitis B, Hib, and Polio vaccine when co-administered with BRV-TV versus when co-administered with RotaTeq
 		 • Till 28 days post vaccination
• 28 days post 3rd dose of vaccination
• 28 days post 3rd dose of vaccination 
 
Target Sample Size   Total Sample Size="1182"
Sample Size from India="1182" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/10/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study would be a Phase III, randomized, controlled, single-blind and comparative study to evaluate non-inferiority of a 3-dose series of the Live Attenuated Tetravalent Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV) to  RotaTeq  when administered along with the routine childhood vaccines in healthy Indian infants. The study subjects will be followed for 28 days after each dose for any event of AE/SAE.  
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