| CTRI Number |
CTRI/2019/04/018575 [Registered on: 12/04/2019] Trial Registered Prospectively |
| Last Modified On: |
15/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Other |
|
Public Title of Study
|
Typbar TCV 7 years followup - to determine the long term persistence of immune response of Typbar TCV |
|
Scientific Title of Study
|
AN EXTENSION OF BBIL/CTP/04/2010 PHASE 3 CLINICAL TRIAL OF TYPBAR TCV®: To DETERMINE THE LEVEL OF ANTI-SALMONELLA TYPHI VI POLYSACCHARIDE IGG ANTIBODIES AT THE END OF APPROXIMATELY 7 YEARS 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 AND ADULTS |
| Trial Acronym |
Typbar TCV® 7 years followup study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BBIL/TCV-Typbar/Ext-III/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
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 |
Bharat Biotech International Limited
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 |
Bharat Biotech International Limited
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 Genome valley Shameerpet Hyderabad 500078 |
|
|
Primary Sponsor
|
| Name |
Bharat Biotech International Ltd |
| Address |
Genome Valley Hyderabad 500078 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr B Sudhakar |
Anu Hospital |
Kovelamudivari St
Suryaraopet, 4th floor,
Vijayawada - 520 002
Krishna
ANDHRA PRADESH |
9885066297
0866-2434855
drbsudhakar@gmail.com |
| DrMonjori Mitra |
ICH Kolkata |
11 DR.Biresh Guha Street
Ground floor
Kolkata-700017
Kolkata
WEST BENGAL |
22905686
2289-3242
monjorimr@gmail.com |
| Dr P Venugopal |
King George Hospital |
Department of Paediatrics
Andhra medical college
Maharanipeta, 1st floor, unit II
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
G2 Floor, SHerwati floor
Belgavi-590010
Bangalore
KARNATAKA |
9448157237
niranjanasn@yahoo.com |
| Dr Ayub Sheikh |
Mahavir Hospital Research center |
Mahavir Hospital Researh center Bhagawan Mahavir Marg AC Gaurds 1st floor
Hyderabad
Hyderabad
TELANGANA |
9030291601
ayub.sk3381@gmail.om |
| DrJBhuvaneshwara Rao |
Yalamanchi Hospital & Research Centres PVT.LTD |
D.No.29-7-44
Venkataratnam Street
Suyaraopet, 1st floor
Vijawayada-520002
Krishna
ANDHRA PRADESH |
9849084660
0866-2435988
jnvbrao@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| AnuHospitalsEthicsCommittee |
Approved |
| Institutional Ethics Committe Bhagawan Mahavir Medical Research Center for Biomedical Researh |
Approved |
| Institutional Ethics Committee King George Hopsital |
Approved |
| Institutional Ethics Committee KLE university |
Approved |
| Yalamanchi Hospitals and Research Center Pvt Ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention of typhoid |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Typbar TCV |
0.5ml by intramuscular route at day 0 |
|
|
Inclusion Criteria
|
| Age From |
7.50 Year(s) |
| Age To |
52.50 Year(s) |
| Gender |
Both |
| Details |
1.Healthy primed children and adults who participated in BBIL/CTP/04/2010 phase 3 and its addendum (initiated: August 2011) follow-on extension clinical trial
2.Adults and 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 adult subject or 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
|
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 |
To evaluate the safety and tolerability of booster dose of Typbar TCV®
a)Proportion of participants with local and systemic adverse events
b)Proportion of participants with Serious Adverse Events.
|
Day 0
Day 28 |
|
|
Target Sample Size
|
Total Sample Size="981"
Sample Size from India="981"
Final Enrollment numbers achieved (Total)= "318"
Final Enrollment numbers achieved (India)="318" |
|
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
|
not appalicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study is an extension of BBIL/CTP/04/2010 phase 3 clinical trial, which was approved by CDSCO on 9 August 2011. This study compared Typbar TCV®with reference Typbar® in 981 subjects aged between 6 months and 45 years across 8 sites in India. An addendum was approved by CDSCO on 22 November 2013 wherein a booster dose for Typbar TCV® was administered to 376 subjects. An extension of BBIL/CTP/04/2010 phase 3, 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 and adults primed with Typbar® and Typbar TCV®. Prior to administration of booster dose of Typbar TCV®, all the primedand boosteredsubjects 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 byShousun 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. CTRI/2011/08/001957 - CTRI number for the first stuy |