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CTRI Number  CTRI/2019/06/019863 [Registered on: 26/06/2019] Trial Registered Prospectively
Last Modified On: 22/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine
Biological 
Study Design  Randomized Factorial Trial 
Public Title of Study   to determine the long term persistence of immune response of Typbar TCV 
Scientific Title of Study   AN EXTENSION OF BBIL/TCV/IV/2013 PHASE 4 NON-INTERFERENCE CLINICAL TRIAL IN CHILDREN WHO WERE ADMINISTERED TYPBAR TCV® CONCOMITANTLY WITH MEASLES-CONTAINING VACCINE CHILDREN AT 9 MONTHS OF AGE: TO DETERMINE THE LEVEL OF ANTI-SALMONELLA TYPHI VI POLYSACCHARIDE IGG ANTIBODIES AT THE END OF 4 YEARS AND FOLLOW UP OF A BOOSTER DOSE OF TYPBAR TCV® DOSE IN THOSE WHO HAVE LOWER OF ANTIBODIES (BELOW CORRELATE OF PROTECTION) IN HEALTHY PRIMED CHILDREN  
Trial Acronym  Typbar TCV with measles vaccine 
Secondary IDs if Any  
Secondary ID  Identifier 
BBIL/TCV-MCV/Ext-I/2018  Protocol Number 
BBIL/TCV-MCV/Ext-I/2018 version 1.1 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  Bharat Biotech International Limited Genome Valley shameerpet Hyderabad
Genome Valley shameerpet
Medchal
TELANGANA
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  Bharat Biotech International Limited Genome Valley shameerpet Hyderabad
Genome Valley shameerpet
Rangareddi
TELANGANA
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  Bharat Biotech International Limited Genome Valley shameerpet Hyderabad
Genome Valley shameerpet
Rangareddi
TELANGANA
500078
India 
Phone  04023480422   
Fax  04023480560  
Email  rajeshri3822@bharatbiotech.com  
 
Source of Monetary or Material Support  
Not applicable 
 
Primary Sponsor  
Name  Bharat Biotech International Ltd  
Address  Genome Valley Shameerpet-500078 
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 
Prashanth Siddaiah  Cheluvamba Hospital  Mysore Medical College and Research Institution Irwin Road Mysore-570001
Mysore
KARNATAKA 		 9606352062
0821-2520512
drsp2013@rediffmail.com 
Monjori Mitra  Institute Of Child Health  11 Dr Biresh Guha Street Kolkata-700017
Kolkata
WEST BENGAL 		 9831075734

monjorimr@gmail.com 
Dr Vasant Khalatkar  Khalatkar Hospital  R-28 & R-29 Reshimbag Umrer Road Nagpur-09
Nagpur
MAHARASHTRA 		 9823044438
0712-27440600
vasant.khalatkar@gmail.com 
DR P Venugopal  King George Hospital  Department of Paediatrics Andhra medical college Maharanipeta Vishakapatnam - 530002
Visakhapatnam
ANDHRA PRADESH 		 9848027203

fbnc.amc@gmail.com 
Dr N S Mahantshetti  KLE ,Belgaum  KLEs Dr Prabhakar Kore hospital & MRC J N Medical college Nehru nagar Belgavi-590010
Bangalore
KARNATAKA 		 9448157237
0831-2471350
niranjanasn@yahoo.com 
Dr Sandeep Mogre  Mogre Hospital  Tajshree Govind Sakkardara Square Umred Road Nagpur-440 009
Nagpur
MAHARASHTRA 		 9822201872
0712-2741827
sandeepmogre@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Institutional Ethics Committee King George Hopsital  Approved 
Institutional Ethics Committee KLE university  Submittted/Under Review 
Institutional Ethics Committee Mysore Medical college and Research Institute   Submittted/Under Review 
Institutional Ethics Committee of Institute of Child Health  Submittted/Under Review 
Jasleen Hospital Institutional Ethics Committee Nagpur  Submittted/Under Review 
Jasleen Hospital Institutional Ethics Committee Nagpur  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Typhoid Infection 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  TYPBAR TCV   O.5 ml Typbar TCV administered at DAY 0 
 
Inclusion Criteria  
Age From  4.80 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  1.Healthy primed children who participated in BBIL/TCV/IV/2013 phase 4 clinical trial (Initiated April 2014)
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 IgG titer 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   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Estimating the level of anti-salmonella typhi Vi polysaccharide IgG antibodies in healthy primed and boostered children who participated in the BBIL/TCV/IV/2013 phase 4 clinical trial.
b)28 days following a booster dose in those who have ≤2μg/mLanti-salmonella typhi Vi polysaccharide IgG antibodies 		 screening, day 0 and 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="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   10/07/2019 
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   NA 
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/2013phase 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 infants primed with Typbar TCV® and measles vaccine.
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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