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CTRI Number  CTRI/2019/07/020451 [Registered on: 30/07/2019] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Vaccine
Biological
Preventive 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to assess the safety and tolerability of Typhoid conjugate vaccine of BE when administered as a single dose. 
Scientific Title of Study
Modification(s)  		 A multicentre single arm non-comparative Phase-III study to evaluate the safety and tolerability of single intramuscular dose of Biological E’s Vi-capsular Polysaccharide-CRM197 Conjugate Typhoid Vaccine in ≥6 months old infants to 45 years old adults. 
Trial Acronym  None 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
BECT057/TCV-Phase-III/CTP-02 Version :2.0 dated:03.10.19  Protocol Number 
None  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrTSA Kishore 
Designation  Associate Vice President - Clinical Development  
Affiliation  Biological E.Limited 
Address  Clinical affairs & Pharmacovigilance Dept, 2nd floor, Road No.35,Jubilee Hills

Hyderabad
TELANGANA
500033
India 
Phone  04071216247   
Fax  04027675309   
Email  kishore.turaga@biologicale.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Subhash Thuluva 
Designation  Vice President - Clinical Development  
Affiliation  Biological E.Limited 
Address  Clinical affairs & Pharmacovigilance Dept, 2nd floor, Road No.35,Jubilee Hills

Hyderabad
TELANGANA
500033
India 
Phone  04071216000   
Fax  04027675309   
Email  subhash.thuluva@biologicale.com  
 
Details of Contact Person
Public Query  
Name  Dr Subhash Thuluva 
Designation  Vice President - Clinical Development  
Affiliation  Biological E.Limited 
Address  Clinical affairs & Pharmacovigilance Dept, 2nd floor, Road No.35,Jubilee Hills

Hyderabad
TELANGANA
500033
India 
Phone  04071216000   
Fax  04027675309   
Email  subhash.thuluva@biologicale.com  
 
Source of Monetary or Material Support  
Biological E.Limited, 18/1&3, Azamabad, Hyderabad-500020, Telangana, India.  
 
Primary Sponsor  
Name  Biological ELimited 
Address  18/1&3, Azamabad, Hyderabad-500020, Telangana, India.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 15  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr S Prashanth  Cheluvamba Hospital  Dept. of Paediatrics,Ground floor, Cheluvamba Hospital, Mysore Medical College & Research Institute, Irwin Road-570001
Mysore
KARNATAKA 		 08105028742

drsp2013@rediffmail.com 
Dr Pavan Hegde  Father Muller Medical College & Hospital  Department of Pediatrics, Ist floor,Father Muller Road, Kankanady, Mangaluru- 575002
Dakshina Kannada
KARNATAKA 		 09845088116

pavanhegde@hotmail.com 
Dr K Siva Ram Prasad  Gandhi Medical College & Hospital  Department of Pediatrics,Ist floor,Musheerabad, Secunderabad-500003
Hyderabad
TELANGANA 		 09440424545

ksivaramaprasad@yahoo.com 
Dr Manish Narang  Guru Teg Bahadur Hospital  Department of Pediatrics, 3rd floor, Dilshad Garden, Shahdara-110095
North East
DELHI 		 09811036569

manish_2710@yahoo.com 
Dr Mandyam Dhati Ravi   J.S.S. Hospital  Department of Pediatrics,Ist floor, Mahathma Gandhi Road- 570004
Mysore
KARNATAKA 		 09880629506

ravimdped@gmail.com 
Dr Kapil Garg  Jay Kay Lon Hospital attached to S.M.S. Medical College  Department of Pediatrics,1st floor, JLN Marg-302004,
Jaipur
RAJASTHAN 		 09829182888

drkapilgargjkl@gmail.com 
Dr Sonali Kar  Kalinga Institute of Medical Sciences (KIMS)  Department of community Medicine, Ist floor,KIIMS Campus 5, KIIT University, Patia, Bhubaneswar – 751024
Khordha
ORISSA 		 09438423273

sonsam72@yahoo.co.uk 
Dr P Venugopal   King George Hospital   Dept. of Paediatrics, 1st floor, King George Hospital,Collectorate Junction, Maharanipeta- 530002
Visakhapatnam
ANDHRA PRADESH 		 09848027203

fbnc.amc@gmail.com 
Dr Madhukar Pandey  Oriana Hospital  Department of Pediatrics,1st floor,Plot number 6, 7, 8 Ravindrapuri Extension, Lanka, Anandbagh, Bhelupur-221001.
Varanasi
UTTAR PRADESH 		 09839439464

pandeymadhukar@gmail.com 
Dr J S Kushwaha   Prakhar Hospital Pvt. Ltd  Department of Pediatrics,2nd floor, 8/219, Arya Nagar -208 002
Kanpur Nagar
UTTAR PRADESH 		 09866330090

prakharhospitalresearch@gmail.com 
Dr Savita Verma  PT. B D Sharma Post Graduate Institute of Medical Sciences & Hospital  Department of Pharmacology, 3rd floor,Near Directorate Office-124 001
Rohtak
HARYANA 		 09812283746

savita_verma@hotmail.com 
Dr Ashish Dhongade   Sant Dnyaneshwar Medical Education & Research Centre  Department of Pediatrics, Ground floor, 695/A, Sadashiveth, 695/A, Sadashiv Peth, Opp. Vijay Talkies, Laxmi Road-411030
Pune
MAHARASHTRA 		 09011095436

adhongade1@gmail.com 
Dr Mohammed Abdul Rahman   Siddhartha Medical College & Govt. General Hospital   Dept. of Paediatrics, Ground floor, Siddhartha Medical College & Govt. General Hospital, Ring Road, Gunadala – 520008
Krishna
ANDHRA PRADESH 		 09848098273

doctorahman@yahoo.co.in 
Dr Dinesh Kaul  Sir Ganga Ram Hospital  Sir Ganga Ram Hospital, Department of Pediatrics, 2nd floor, Old Rajinder Nagar-110060
New Delhi
DELHI 		 09811211205

docdineshkaul@gmail.com 
Dr Bala Kishor   St. Theresas Hospital  Dept. of Paediatrics,1st floor, St. Theresa’s Hospital, Sanathnagar -500018
Hyderabad
TELANGANA 		 9949046236

baki2004@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 15  
Name of Committee  Approval Status 
Ethics Committee of the prakhar Hospital   Submittted/Under Review 
Ethics Committee, SMS Medical College and Attached Hospitals   Submittted/Under Review 
Ethics Committee, St. Theresa’s Hospital  Submittted/Under Review 
Guru Teg Bahadur Ethics Committee-Guru Teg Bahadur Hospital   Approved 
Institutional Ethics Committee, Gandhi Medical College/ Gandhi Hospital   Submittted/Under Review 
Institutional Ethics Committee, JSS Medical College & Hospital   Submittted/Under Review 
Institutional Ethics committee, Kalinga Institute of Medical Sciences   Submittted/Under Review 
Institutional Ethics Committee, Mysore Medical College and Research Institute and Associated Hospitals   Approved 
Institutional Ethics Committee, Oriana Hospital   Approved 
Institutional Ethics Committee, PT. B D Sharma Post Graduate Institute of Medical Sciences   Submittted/Under Review 
Institutional Ethics Committee, Siddhartha Medical College & Govt. General Hospital   Submittted/Under Review 
Institutional Ethics Committee,Sant Dnyaneshwar Medical Education Research Centre   Submittted/Under Review 
Institutional Ethics committee- Father Muller Medical College   Approved 
Institutional Ethics Committee- King George Hospital  Approved 
Sir Ganga Ram Hospitals Ethics Committee, Delhi  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Preventive protection against Typhoid fever  
Patients  (1) ICD-10 Condition: Z23||Encounter for immunization,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BioE’s Typhoid Conjugate Vaccine(Monovalent)- Single Human dose-0.5mL   1. Dose: 0.5 mL single dose 2. Frequency: One dose only 3. Route of administration: intramuscular injection 4. Total duration of therapy:42 days (post single dose administration)  
Comparator Agent  None  None 
 
Inclusion Criteria
Modification(s)  
Age From  6.00 Month(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Healthy subjects of either gender between ≥6 months to ≤45 years of age at the time of vaccination
2. Subject or Subject’s Parent(s) or LAR who after the nature of the study has been explained to them, have given written consent according to local regulatory requirements.
3. Subject or Subject’s Parent(s) or LAR’s ability to understand information relevant to participation in the study and abide with the requirements of the subject diary and other study procedures;
4. Individuals in good health as determined by the outcome of medical history, physical examination based on clinical judgment of the investigator.
5. Negative to urine pregnancy test for female subjects of childbearing potential. Female of childbearing potential is defined as a pre-menopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: (1) menopause at least 2 years earlier, (2) tubal ligation at least 1 year earlier, or (3) total hysterectomy.
 
 
ExclusionCriteria 
Details  1. Individuals who have previously received any vaccines against typhoid fever (either oral live attenuated or injectable vaccines);
2. Individuals with body temperature ≥100.4°F (≥38.0°C) within 3 days of intended study immunization;
3. Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g., neurological, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease);
4. Subject or Subject’s Parent(s) or LAR unwillingness or inability to understand and follow required study procedures, keep appointments, or are planning to relocate during the study period;
5. Individuals with history of any illness or any laboratory abnormality that, in the opinion of the investigator, which might pose additional risk to the subjects due to participation in the study;
6. Subject with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time or history of receipt of anti-coagulants in the past 3 weeks;
7. History of allergy or allergic reaction to any vaccine-related component;
8. Individuals participated/participating in any other clinical trial within 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study;
9. Women who are pregnant or breast-feeding or of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Female of childbearing potential or age is defined as a pre-menopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: (1) menopause at least 2 years earlier, (2) tubal ligation at least 1 year earlier, or (3) total hysterectomy.
10. Any other reason that in the opinion/judgement of the investigator may interfere with the evaluation required by the study objectives.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Proportion of subjects with solicited adverse reactions.
2.Proportion of subjects with unsolicited adverse events (AEs).
3.Medically attended and/or serious adverse events (SAEs), if any,  		 1.during first 30 minutes of post vaccination observation period and for subsequent 7 consecutive days (Day 0-6) for any solicited adverse events captured through subject diary.
2.during the follow up period until day 42 of post vaccination.
3.during the post vaccination 42 days follow up period. 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="1770"
Sample Size from India="1770" 
Final Enrollment numbers achieved (Total)= "1770"
Final Enrollment numbers achieved (India)="1770" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 16/03/2020 
Date of Study Completion (India) 30/06/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

This is a single arm non-comparative, multicentre phase-III safety study to assess overall safety and tolerability of Biological E’s Typhoid Vi-CRM197 conjugate vaccine  in  â‰¥6 months to 45 year old  subjects.

The target population for this study would be ≥6 months to 45 year of age subjects of either gender at the time of vaccination.All enrolled subjects would be followed up for a period of 42 days after a single dose of Biological E’s Typhoid Vi-CRM197 conjugate Vaccine administration. In the current study, a total of 1770 healthy subjects of either gender will be enrolled to receive Biological E’s Typhoid Vi-CRM197 conjugate vaccine.

The study will be conducted in compliance with schedule Y, ICH and Indian good clinical practice guidelines in force at the time of study conduct.

 
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