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CTRI Number  CTRI/2012/07/002820 [Registered on: 23/07/2012] Trial Registered Prospectively
Last Modified On: 31/07/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to evaluate safety of Rotavirus vaccine in Healthy Adult Volunteers followed by Safety, Tolerability and Immunogenicity evaluation in healthy infants. 
Scientific Title of Study   A Phase I/II Study of the All In One Liquid Formulation of a Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus vaccine (BRV-TV) to Sequentially Evaluate the Safety and Tolerability of a Single Dose in Healthy Adult Volunteers Followed by Evaluation of the Safety, Tolerability and Immunogenicity (Dose Response) of a Three Administration Series in Healthy Infants in India. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SBL/BRV-TV/005 Version 2.0 Dated: 15 Sept.2011  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 Mandeep Singh DhingraMD 
Designation  Chief Clinical, PV and CQA Officer 
Affiliation  Shantha Biotechnics Limited 
Address  Shantha Biotechnics Limited, 3rd and 4th Floor, Vasantha Chambers, #5-10-173, Fateh Maidan Road, Basheer Bagh

Hyderabad
ANDHRA PRADESH
500004
India 
Phone  04066301000  
Fax    
Email  drmandeep@shanthabiotech.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Mandeep Singh DhingraMD 
Designation  Chief Clinical, PV and CQA Officer 
Affiliation  Shantha Biotechnics Limited 
Address  Shantha Biotechnics Limited, 3rd and 4th Floor, Vasantha Chambers, #5-10-173, Fateh Maidan Road, Basheer Bagh


ANDHRA PRADESH
500004
India 
Phone  04066301000  
Fax    
Email  drmandeep@shanthabiotech.co.in  
 
Source of Monetary or Material Support  
Shantha Biotechnics Limited 
 
Primary Sponsor  
Name  Shantha Biotechnics Limited 
Address  Shantha Biotechnics Limited, 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 = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ritabrata Kundu  Institute of Child Health  Dept. of Pediatrics, Institute of Child Health, Dr. Biresh Guha Street
Kolkata
WEST BENGAL 		 03322905626

rkundu22@gmail.com 
Dr Suman Kanungo  National Institute of Cholera & Enteric Diseases  National Institute of Cholera & Enteric Diseases, P-33, C.I.T. Road, Scheme-XM Beliaghata
Kolkata
WEST BENGAL 		 03323631222

kanungosuman@rediffmail.com 
Dr Madhu Gupta  School of Public Health  Dept. of Community Medicine,School of Public Health, PGIMER
Chandigarh
CHANDIGARH 		 01722755220

madhugupta21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ethical Committee Institute of child Health  Approved 
PGIMER Institutional Ethics Committee  Approved 
The Ethical Committee National Institute   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  Investigational Study Vaccine (BRV-TV)  2.0 mL administered orally at one of three dosage levels. 
Comparator Agent  Placebo  2.0 mL liquid for oral administration (Vaccine formulation without the rotavirus antigen) dose administered orally 
Comparator Agent  RotaTeq  2.0 ml dose administered orally 
 
Inclusion Criteria  
Age From  1.50 Month(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Healthy Adults:
•Healthy Indian adult volunteers between 18 to 55 years of age.
•No apparent signs or symptoms of ill health.
•Properly informed about the study and having signed the informed consent form (ICF). In case of the volunteer 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;
•Subject available for the entire period of the study and reachable by study staff for post vaccination follow-up.
Healthy Infants:
•Healthy infants, of either sex, 6-8 weeks of age at time of enrollment;
•Born after a gestational period of 36-42 weeks with birth weight ≥2kg;
•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;
•Infant/Parent or guardian available for the entire period of the study and reachable by study staff for post-vaccination follow-up.
 
 
ExclusionCriteria 
Details  Healthy adults:
•Known or suspected impairment of immunological function;
•Known hypersensitivity to any component of the rotavirus vaccine;
•Fever, with axillary temperature ≥38.1oC (≥100.5oF); measured by study staff.
•History of chronic diarrhea;
•Clinical evidence of active gastrointestinal illness;
•Receipt of any IM, oral, or IV corticosteroid treatment in the past 30 days
•Subjects suspected to be HIV, HBV or HCV positive from the available clinical history
•Any subject who cannot be adequately followed for safety;
•Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
•Subject unable to maintain diary card
•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.
•Volunteers identified as employees of the investigator or study center, with direct involvement in the proposed study or studies under the direction of that investigator or study center as well as children, adopted or natural, of the employees or Investigator.

Healthy Infants:

•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 rotavirus vaccine;
•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 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.
•Fever, with axillary temperature ≥38.1oC (≥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 including ongoing diarrheal episode (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, nephritic 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
•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 or study center, with direct involvement in the proposed study or studies under the direction of that investigator or study center as well as children, adopted or natural, of the employees or Investigator.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Cohort 1 (Healthy Adults)
Frequency, severity, and causality of REs and other AEs following the dose of Investigational Rotavirus Vaccine as compared to REs and AEs reported for adults administered a single dose of Placebo.
Cohort 2 (Healthy Infants)
Sero-response rate at each antigen concentration level of Investigational Rotavirus vaccine/ Rotateq/Placebo
 		 Cohort 1 (Healthy Adults)
1O days post vaccination
Cohort 2 (Healthy Infants)
28 days post 3rd dose of vaccination 
 
Secondary Outcome  
Outcome  TimePoints 
Cohort 2 (Healthy Infants)
•Frequency, severity, and causality of REs and other AEs following the dose of Investigational Rotavirus Vaccine /Rotateq/Placebo
 		 Till 28 days post vaccination 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   30/07/2012 
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="0"
Months="11"
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 conducted sequentially in two cohorts. 

Cohort 1 would be of 20 healthy adults administered a single dose of highest dose planned of the Live Attenuated Tetravalent Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV) or placebo. The volunteers would be randomized in ratio of 3:1 to receive either a single dose of the BRV-TV vaccine or placebo and will be followed for 10 days for any AE/SAEs.

Cohort 2 would be a Phase I/II, randomized controlled, single-blind, dosage selection and comparative study to describe the safety, tolerability, and immunogenicity of a 3-dose series of either the  Live Attenuated Tetravalent  Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV) or  RotaTeq or Placebo administered along with the routine childhood vaccines in healthy Indian infants and will be followed for 28 days after each dose for any event of AE/SAE.

 
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