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CTRI Number  CTRI/2014/04/004532 [Registered on: 09/04/2014] Trial Registered Prospectively
Last Modified On: 16/03/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized Factorial Trial 
Public Title of Study   Open labeled non-interference Phase IV study of BBIL’s Typbar- TCV with measles vaccine 
Scientific Title of Study   A Phase IV, Randomized, factorial assigned, Open labelled, study to evaluate the non- interference in immune response of Typhoid Vi Capsular Polysaccharide - Tetanus Toxoid Conjugate Vaccine (Typbar-TCV) administered to children at 9 months, to measles vaccine given concomitantly 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BBIL/TCV/IV/2013:Version 1.0; Dated 26/08/2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr B N Patnaik  
Designation  Associate Medical Director  
Affiliation  Bharat Biotech International Ltd  
Address  Genome Valley, Shameerpet

Hyderabad
ANDHRA PRADESH
500078
India 
Phone  04023480567  
Fax  04023480560  
Email  badri2299@bharatbiotech.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr B N Patnaik  
Designation  Associate Medical Director  
Affiliation  Bharat Biotech International Ltd  
Address  Genome Valley, Shameerpet

Hyderabad
ANDHRA PRADESH
500078
India 
Phone  04023480567  
Fax  04023480560  
Email  badri2299@bharatbiotech.com  
 
Details of Contact Person
Public Query
 
Name  Dr B N Patnaik  
Designation  Associate Medical Director  
Affiliation  Bharat Biotech International Ltd  
Address  Genome Valley, Shameerpet

Hyderabad
ANDHRA PRADESH
500078
India 
Phone  04023480567  
Fax  04023480560  
Email  badri2299@bharatbiotech.com  
 
Source of Monetary or Material Support  
Bharat Biotech International Ltd. 
 
Primary Sponsor  
Name  Bharat Biotech International Ltd  
Address  Genome Valley, Shameerpet, Hyderabad-500 078, Andhra Pradesh, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr B Krishana Murthy   Cheluvamba Hospital  Department Of Pediatrics Mysore Medical Collage & Research Institute, Irwin Road
Mysore
KARNATAKA 
09742620007

bkm6@rediffmail.com 
Dr Vasant Khalatkar   Colours Children Hospital  Dr Vasant Khalatkar Colours Children Hospital R 29 Reshimbag Umrer road Nagpur 440009
Nagpur
MAHARASHTRA 
9823044438
07122740500
vasant.khalatkar@gmail.com 
DrMahantshetti  Dr. Prabhakar Kore Hospital and Medical Research Centre  Dr. Prabhakar Kore Hospital and Medical Research Centre Nehru Nagar Belgaum 590010
Belgaum
KARNATAKA 
0831-2473777
08312471350
niranjanasn@yahoo.com 
Dr Monjori Mitra  Institute of Child Health  Room No: 111 Department: OPD Pediatric Division: Institute of Child Health, 11Dr.Biresh Guha Street
Kolkata
WEST BENGAL 
03322908656
03322908656
monjorimr@gmail.com 
Dr P Venugopal  King George Hospital  Department of pediatrics, Ist Floor, King George Hospital
Visakhapatnam
ANDHRA PRADESH 
9848027203

venugopal_kgh@yahoo.com 
Dr Sandeep Mogre   Mogre Hospital  Dr. Sandeep Mogre Mogre Children Hospital 228 Tajshree Govind Apartment Sakkardara Square Umrer Road Nagpur-440009
Nagpur
MAHARASHTRA 
07122741827

mogrehospital@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Committee KLE University  Approved 
Ethics committee, Mysore Medical Collage Research Center , Mysore   Approved 
Institute of Child Health, Kolkata   Approved 
Institutional Ethics committee, King George Hospital, Vishakapatnam  Approved 
Jasleen hospitals Ethics committee, Nagpur  Approved 
Jasleen hospitals Ethics committee, Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  prevention of salmonalla typhi infection 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  M-VAC  Group 4 M-VAC on day 0 
Intervention  M-VAC and Typbar-TCV  Group 2 : M-VAC on Day 0 and Typbar-TCV on day 28 
Intervention  M-VAC co administration with Typbar-TCV  Group 1A : Typbar-TCV and M-VAC concomitantly on Day 0 and 2nd dose of Typbar-TCV on day 28 
Intervention  M-VAC co administration with Typbar-TCV  Group 1B : Typbar-TCV and M-VAC concomitantly on Day 0 and and 2nd dose of Typbar-TCV on day 180  
Intervention  Typbar-TCV and M-VAC  Group 3 Typbar-TCV on Day 0 and M-VAC on day 28 
 
Inclusion Criteria  
Age From  8.00 Month(s)
Age To  10.00 Month(s)
Gender  Both 
Details  1.Parents or Legally Acceptable Representative willing to give signed Informed Consent.
2. Infants aged 8 to 10 months.
3. Subjects should be available for the next 2 years for followup.
4. Subject, who has not received Measles vaccine or Typhoid vaccine.
5. Subjects are not currently participating in any other clinical trial or are in receipt of any other Investigational product in the last 06 months 
 
ExclusionCriteria 
Details  1.Presence of any illness requiring hospital referral on the day
of Vaccine administration, temporary exclusion.
2. Known immunodeficiency.
3. Receipt of Blood products in the last 06 months.
4.Known case of HIV or other major Immunological
abnormalities.
5. In receipt of Systemic Immunosuppressant or systemic cortico-steroids.
6. Any household contact on Immunosuppressant.
7. Known allergy to any component of the Vaccine 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine whether TCV can be successfully co administered with Measles vaccine at 9 months without interfering with the
immune response to Measles at 4 & 8 weeks post vaccination as compared to baseline. (Group 1A & 1B)
2.To determine the effect (anti-Vi antibodies) of booster dose
administration with TCV vaccine at day 28±2 (Group 1A) and at day 180±15 (Group 1B) as compared to baseline and single dose response. (Group 2 & 3) 
To determine whether TCV can be successfully co administered with Measles vaccine at 9 months without interfering with the
immune response to Measles at 4 & 8 weeks post vaccination as compared to baseline. (Group 1A & 1B)
2.To determine the effect (anti-Vi antibodies) of booster dose
administration with TCV vaccine at day 28±2 (Group 1A) and at day 180±15 (Group 1B) as compared to baseline and single dose response. (Group 2 & 3) 
 
Secondary Outcome  
Outcome  TimePoints 
GMTs of serum Vi antibodies and proportion that seroconvert
(four fold rise in titres to serum Vi antibodies) 
To measure the GMTs and seroconversion at day 0,day 28±2, day 56±7,180±15,360±30 and 720±30

safety for 2 years 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/04/2014 
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="2"
Months="0"
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  

Typhoid fever continues to be important causes of illness and death, particularly among children and adolescents in south-central and Southeast Asia, where enteric fever is associated with poor sanitation and unsafe food and water. High-quality incidence data from Asia are underpinning efforts to expand access to typhoid vaccines. Efforts are underway to develop vaccines that are immunogenic in infants after a single dose and that can be produced locally in countries of endemicity. Antimicrobial resistance has sequentially emerged to traditional first-line drugs, fluoroquinolones, and third-generation cephalosporins, posing patient treatment challenges. The Vi conjugate typhoid vaccine, Typbar-TCV under clinical trial have been found to be highly immunogenic in infants and children less than 2 years of age in which unconjugated Vi polysaccharide typhoid vaccine is known to induce very low or nil immunogenic response.

 

Early Immunizations not only prevent mortality and morbidity but also reduce the expenditure of public and private resources. Introduction of Typhoid vaccine with measles vaccine at 9 months of age in routine EPI programs will not substantially interfere with measles elimination programs and will eliminate the need of an additional typhoid vaccination visit in the already clustered initial EPI Immunization visits. The current study proposed to evaluate immunogenicity and safety when co-administered with measles vaccine. The objective is to determine whether TCV can be successfully co-administered with Measles without interfering with the immune response to each of these antigens.

 

This open labeled, randomized, parallel study to evaluate the non- interference in immune response of one dose of Typhoid Vi Capsular Polysaccharide-Tetanus Toxoid Conjugate Vaccine (Typbar-TCV) administered to children at 9 months, to measles vaccine given concomitantly.

The subjects will be screened for eligibility in to the study after obtaining written informed consent from the subject. Screening period might last for 7 days. Screening includes obtaining medical history, physical examination, demographic details (weight, height & gender), Vital signs (Heart rate, respiratory rate, body temperature-oral or axillary) and clinical evaluations.

After completion of the screening process, the eligible, subjects shall be enrolled into the study groups. Subjects shall be observed for 30 minutes after vaccination, and for the next 7 days, recorded in the subject diary cards.

 
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