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CTRI Number  CTRI/2019/04/018634 [Registered on: 15/04/2019] Trial Registered Prospectively
Last Modified On: 22/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To determine long term persistence of immune response of Typbar TCV 
Scientific Title of Study   AN EXTENSION OF BBIL/TCV/IV-3/2015 PHASE 4 CLINICAL TRIAL OF TYPBAR TCV®WITH COMPARATOR TYPHIM Vi®: TO DETERMINE THE LEVEL OF ANTI-SALMONELLA TYPHI VI POLYSACCHARIDE IGG ANTIBODIES AT THE END OF APPROXIMATELY 2 YEARS 6 MONTHS AND FOLLOW UP OF A BOOSTER DOSE OF TYPBAR TCV® DOSE IN THOSE WHO HAVE LOWER LEVEL OF ANTIBODIES (BELOW CORRELATE OF PROTECTION) IN HEALTHY PRIMED AND BOOSTER DOSE RECEIVED CHILDREN 
Trial Acronym  Typbar TCV with Typhim Vi 
Secondary IDs if Any  
Secondary ID  Identifier 
BBIL/TCV/IV-3/2015 Version 1.1 Effective Dated: 15 Nov 2018  ClinicalTrials.gov 
BBIL/TCV/IV-3/2015 Version 1.1 Effective Dated: 15 Nov 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajeshri 
Designation  Sr manager 
Affiliation  Bharat Biotech International Limited 
Address  Genome valley Shameerpet Hyderabad
Genome valley Shameerpet Hyderabad
Rangareddi
ANDHRA PRADESH
500078
India 
Phone  04023480422   
Fax  04023480560  
Email  rajeshri3822@bharatbiotech.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajeshri 
Designation  Sr manager 
Affiliation  Bharat Biotech International Limited 
Address  Genome valley Shameerpet Hyderabad
Genome valley Shameerpet Hyderabad
Rangareddi
ANDHRA PRADESH
500078
India 
Phone  04023480422   
Fax  04023480560  
Email  rajeshri3822@bharatbiotech.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajeshri 
Designation  Sr manager 
Affiliation  Bharat Biotech International Limited 
Address  Genome valley Shameerpet Hyderabad
Genome valley Shameerpet Hyderabad
Rangareddi
ANDHRA PRADESH
500078
India 
Phone  04023480422   
Fax  04023480560  
Email  rajeshri3822@bharatbiotech.com  
 
Source of Monetary or Material Support  
Bharat Biotech International Limited 
 
Primary Sponsor  
Name  Bharat Biotech international Limited 
Address  Genome Valley Shameerpet 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K Sivaram Prasad  Gandhi Medical College and Hospital  Musheerabad Secunderabad
Hyderabad
ANDHRA PRADESH 		 9440424545
9140-27504441
sivaram175@yahoo.com 
Mohammed Abdul Rahman  Govt.Siddhartha Medical College  Ring Road Gunadala Vijayawada
Krishna
ANDHRA PRADESH 		 9848098273

doctorahman@yahoo.co.in 
DR P Venugopal  King George Hospital  Department of Paediatrics Andhra medical college Maharanipeta Vishakapatnam - 530002
Visakhapatnam
ANDHRA PRADESH 		 9848027203

fbnc.amc@gmail.com 
Dr V K Goyal  Panchsheel Hospital  C-3/63-A 64-A Yamuna Vihar (opposite Police Station)
New Delhi
DELHI 		 9850303972
22914816
vkgoyal22@gmail.com 
DR RamchandraKeshav Dhongade  Sant Dyaneshwar  695-A Sadashiv Peth Laxmi Road Opp.Vijay Talkies Pune
Pune
MAHARASHTRA 		 9011095436

ramchandradhongade@gmail.com 
Dr Satish  Seven Hills Hospital  Seven Hills Hospital Waltair uplands Vishakapatnam 02
Visakhapatnam
ANDHRA PRADESH 		 7207123400

satishvadapalli60@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Committee Panchsheel Hospital  Submittted/Under Review 
Institutional ethics Committee Gandhi Medical College Secunderabad   Submittted/Under Review 
Institutional Ethics Committee King George Hopsital  Approved 
Institutional Ethics Committee Seven Hills Hospital  Submittted/Under Review 
Institutional Ethics Committee Siddhartha Medical College and Govt General Hospital  Approved 
Sant Dnyaneshwar Medial Education Research Center Institutional Review board  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  prevention of typhoid 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Typbar TCV   0.5 ml by intramuscular route 
Intervention  Typbar-TCV  O.5 ml Typbar TCV administered at DAY 0 
Comparator Agent  Typhim Vi  0.5 ml by intramuscular route 
 
Inclusion Criteria  
Age From  4.50 Year(s)
Age To  17.50 Year(s)
Gender  Both 
Details  1.Healthy primed children who participated in BBIL/TCV/IV-3/2015 phase 4 clinical trial (Initiated: January 2016)
2.For minor subjects whose parent or guardian is able to understand planned study procedures comprehend and will comply with the requirements of the protocol procedures
3.Written informed consent obtained from subjects parent or guardian (if minor) prior to performance of any study specific procedure
4.Generally healthy subjects without acute or chronic, clinically significant pulmonary cardiovascular hepatic or renal functional abnormality as determined by physical examination
 
 
ExclusionCriteria 
Details  1.Primed and boostered subjects whose anti-salmonella Vi-polysaccharide IgGtiter are found to be >2µg/mL.
2.Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines or vaccines as per UIP schedule during the study period.
3.Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product for typhoid).
4.Administration of long-acting immune-modifying drugs (e.g. infliximab, rituximab) at any time during the study period.
5.Any confirmed or suspected immunosuppressive or immune-deficient condition, based on medical history and physical examination (e.g. Severe Combined Immunodeficiency Disease).
6.Subject with history of hypersensitivity to the vaccine or any of its composition or a present or past history of allergic reactions
7.Subjects suffering from acute or chronic infections or any other serious liver, renal, cardiac, respiratory or metabolic disease
8.Subjects with uncontrolled epilepsy or other progressive diseases of nervous system
9.Subjects unwilling to comply with the study procedures
10.Infection with Human Immunodeficiency Virus (HIV) regardless of clinical stage of immunodeficiency or current autoimmune disease.
11.Have signs or symptoms that could confound or confuse assessment of study vaccine reactogenicity
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the long term persistence of immune response of Typbar TCV  day -60 to -1
day 0
day 28 
 
Secondary Outcome  
Outcome  TimePoints 
•Proportion of participants with local and systemic adverse events
•Proportion of participants with Serious Adverse Events
 		 Day 28 
 
Target Sample Size   Total Sample Size="340"
Sample Size from India="340" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/04/2019 
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="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

An extension of BBIL/TCV/IV-3/2015phase 4, randomized, multicentric study to evaluate the immunogenicity and safety of booster dose of typhoid Vi capsular polysaccharide-tetanus toxoid protein conjugate vaccine (Typbar TCV®) administered in healthy children primed with Typhim Vi® and Typbar TCV®.

 

Prior to administration of booster dose of Typbar TCV®, all the primed and boostered subjects will be evaluated for anti-salmonella Vi-polysaccharide IgG. Only those subjects found not to be having the protective level of antibody titer(≤2µg/mL as measured by Shousun C. Szu et al method) will be given a booster dose and will be assessed for boosting effect of Typbar TCV® by measuring the immunogenicity after a period of 28 days.

 
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