| CTRI Number |
CTRI/2024/06/069638 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Other |
|
Public Title of Study
|
A Phase III Study to Evaluate the Immunogenicity and Safety of Typbar TCV Typhoid Vaccine in Adults greater than 65 Years. |
|
Scientific Title of Study
|
A Phase III Open-label Study to Evaluate the Immunogenicity and Safety of Typhoid Tetanus Toxoid Conjugate Vaccine, Typbar TCV® in Adults (greater than 65 Years). |
| Trial Acronym |
Typbar-TCV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BBIL/TCV-III/2023 Version No: 2.0; Date: 03 Nov 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Krishna Mohan |
| Designation |
Executive Director |
| Affiliation |
Bharat Biotech international limited |
| Address |
Medical Affairs Department, S Block, Genome valley Shameerpet, Hyderabad Hyderabad TELANGANA 500078 India
Hyderabad
TELANGANA
500078
India |
| Phone |
914023480567 |
| Fax |
914023480560 |
| Email |
kmohan@bharatbiotech.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Krishna Mohan |
| Designation |
Executive Director |
| Affiliation |
Bharat Biotech international limited |
| Address |
Medical Affairs Department, S Block, Genome valley Shameerpet, Hyderabad Hyderabad TELANGANA 500078 India
Hyderabad
TELANGANA
500078
India |
| Phone |
914023480567 |
| Fax |
914023480560 |
| Email |
kmohan@bharatbiotech.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Krishna Mohan |
| Designation |
Executive Director |
| Affiliation |
Bharat Biotech international limited |
| Address |
Medical Affairs Department, S Block, Genome valley Shameerpet, Hyderabad Hyderabad TELANGANA 500078 India
Hyderabad
TELANGANA
500078
India |
| Phone |
914023480567 |
| Fax |
914023480560 |
| Email |
kmohan@bharatbiotech.com |
|
|
Source of Monetary or Material Support
|
| Bharat Biotech International Limited Genome valley Shameerpet Hyderabad |
|
|
Primary Sponsor
|
| Name |
Bharat Biotech International Limited |
| Address |
Bharat Biotech International Ltd., Sy. No. 230,231 & 235, Genome Valley, Turkapally, Shameerpet Mandal, Medchal - Malkagiri District, Telangana (India) - 500078 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Pandey |
All India Institute Medical Sciences Patna |
Dept. of community& Family Medicine, All India Institute of Medical Sciences, Patna- Aurangabad Road, Phulwari sharif, Patna, Bihar 801507
Patna
BIHAR |
7783892746
drsanjaypandey72@gmail.com |
| Dr Leelabati Toppo |
Malla Reddy Hospital |
1st floor, General medicine, Malla reddy college for women, suraram, hyderabad, telnagana Hyderabad TELANGANA
Hyderabad
TELANGANA |
8886436633
Leelabati.rath@gmail.com |
| Dr Savita Verma |
Post Graduate Institute of Sciences Rohtak |
Department of pharmacology, Floor -2, Pt.B.D,(PGIMS),UHS, Rothak-124001, Haryana. Rohtak HARYANA
Rohtak
HARYANA |
9812283746
verma.savi@gmail.com |
| Dr Sagar Vivek Redkar |
Redkar Hospital and Research center |
2nd floor, Mumbai Goa national highway, Dhargal, Taluka pemam, North Goa 403513 North Goa GOA
North Goa
GOA |
7776084679
redkar.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe All India Institute Medical Sciences Patna |
Approved |
| Institutional Ethics Committe, Malla Reddy Medical College for Women, Hyderabad |
Approved |
| Institutional Ethics Committee PGIMS Rohtak |
Approved |
| Rekar Hospital and Research center institutional Ethics Committe, Redkar Goa |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Typbar TCV |
Typhoid Conjugate Vaccine
A single dose of 0.5 ml of Typbar TCV® will be administered intramuscularly in the deltoid region of the arm ON Day 0 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of age ≥18 without significant medical history or abnormal
clinical findings
2. Subject who has been explained about all risks and benefits of the
Trail and is willing to provide written informed consent.
3. Agrees to be available for all Trail related visits and procedures
throughout the duration of the Trail.
4. Female subjects of child bearing potential must demonstrate a negative
urine pregnancy test at the time of screening.
5. Individuals who are in good health as determined by the outcome of
medical history, physical examination and based on clinical judgement of
the Principal Investigator.
|
|
| ExclusionCriteria |
| Details |
1. Subjects who are under the age of 18 years
2. Fever of any origin or duration for more than 3 days prior to intended Trail immunization
3. History of Typhoid vaccination in the last 5 years
4. History of Typhoid disease in the last 5 years
5. History of any illness or any laboratory abnormality that, in the opinion of the investigator, might
interfere with the results of the Trail or pose additional risk to the subjects due to participation
in the Trail
6. Individuals with any serious chronic or progressive diseases according to the judgment of
Investigator (eg: neurological, neoplasm, insulin dependent diabetes, hepatic, renal, cardiac
diseases).
7. Any confirmed or suspected use of immunosuppressive drugs or immunodeficient condition.
8. Use of any marketed/investigational/herbal medicine or non-registered drug or vaccine for Typhoid.
9. Any criteria, which in the opinion of the investigator, suggests that the subject may not be
compliant with the Trail protocol.
10. History of allergy or allergic reactions to vaccine or any vaccine component
11. Women who are pregnant or breast-feeding.
12. Married or sexually active participants who are not willing to follow effective birth control
methods for at least 3 months after vaccine.
13. Individuals participating in any other clinical trial within one month prior to Trail participation
or intent to participate in any other clinical trial during the conduct of the Trail
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Proportion of subjects attaining seroconversion (> four-fold rise in anti-salmonella typhi Vi polysaccharide IgG antibody titre compared to baseline), 28±2 days after vaccine administration
2. Anti-Vi IgG GMT will be assessed on Day 0 and Day 28±2.
|
Day 0 and Day 28±2.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Occurrence of solicited local and systemic adverse events, unsolicited adverse events and proportion of subjects with Serious Adverse Events |
1.30 minutes after vaccination
2.Till 7 days
3.Throughout the study period |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
08/07/2024 |
| Date of Study Completion (India) |
11/11/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Phase III Open-label Study to Evaluate the Immunogenicity and Safety of Typhoid Tetanus Toxoid Conjugate Vaccine; Typbar TCV® in Adults (>65 Years)
A total of 300 healthy subjects of age group > 18 year will participate in this study in which approximately 150 subjects will be of age 18-65 years and 150 subjects will be >65 years. On Day 0 (baseline) and Day 28 ±2, 5mL of blood will be collected for immunogenicity testing. Primary objective To evaluate the immunogenicity of Typbar TCV® through the measurement of seroconversion and geometric mean titers of anti-Vi IgG antibodies. Secondary objective To evaluate the Safety of Typbar TCV® in all age groups throughout the study period. Immune responses will be assessed as GMTs and seroconversion rates (> fourfold rise). GMTs will be compared using a 2-sample Student t-test on log transformed titers, and seroconversion rates will be compared using the Pearson χ2 test. Confidence intervals will be calculated from log-transformed titers, using t distribution for GMTs and by adjusted Wald method for seroconversion. Chi-square test or fisher’s exact test will be used to calculate differences in categorical variables and proportion of adverse events reported. Significance will be set at p < 0.025 (1-sided) or p < 0.05 (2-sided). |