| CTRI Number |
CTRI/2020/03/023712 [Registered on: 02/03/2020] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine
Biological
Preventive |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to assess the continued immunological existence of antibodies at 12, 24 and 36 months after receiving the primary dose. |
|
Scientific Title of Study
|
A multicentre follow-up study to assess the immunological persistence of anti-Vi IgG antibodies at 12, 24 and 36 months post primary dose and to evaluate the immune response to a single booster dose of typhoid Vi conjugate vaccine administered at 36 months post primary dose to 6 months to 45-year-old subjects in both treatment arms who participated in the BECT053 study. |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BECT059/TCV-Phase-III/CTP-01 Version :1.0 dated:09.09.19 |
Protocol Number |
| None |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| 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
Hyderabad
TELANGANA
500033
India |
| Phone |
04071216248 |
| Fax |
04027675309 |
| Email |
subhash.thuluva@biologicale.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kishore TSA |
| Designation |
Associate Vice president - Clinical Development |
| Affiliation |
Biological E.Limited |
| Address |
Clinical affairs & Pharmacovigilance Dept, 2nd floor, Road No.35,Jubilee Hills
Hyderabad
Hyderabad
TELANGANA
500033
India |
| Phone |
04071216247 |
| Fax |
04027675309 |
| Email |
kishore.turaga@biologicale.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kishore TSA |
| 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 |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Biological ELimited |
| Address |
18/1&3, Azamabad, Hyderabad-500020, Telangana, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| 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 and Hospital |
Department of Pediatrics,Ist floor,Musheerabad-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 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 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 |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Ethics Committee, SMS Medical College and Attached Hospitals |
Approved |
| Guru Teg Bahadur Ethics Committee-Guru Teg Bahadur Hospital |
Approved |
| Institutional Ethics Committee, Gandhi Medical College/ Gandhi Hospital |
Approved |
| Institutional Ethics Committee, JSS Medical College & Hospital |
Approved |
| Institutional Ethics committee, Kalinga Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, Oriana Hospital |
Approved |
| Institutional Ethics Committee, PT. B D Sharma Post Graduate Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee,Sant Dnyaneshwar Medical Education Research Centre |
Approved |
| Institutional Ethics committee- Father Muller Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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: Single booster dose only 3. Route of administration: intramuscular injection 4. Total duration of therapy:772 days
|
| Comparator Agent |
Typbar-TCV Single Human dose-0.5mL |
1. Dose: 0.5 mL single dose 2. Frequency: Single booster dose only 3. Route of administration: intramuscular injection 4. Total duration of therapy:772 days |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy primed children, adolescents and adults of either gender between 6 months to 45 years (both inclusive) of age, who participated in a previous phase-II/III study bearing No.BECT053.
2. Subjects who are willing to participate and who would be expected to comply with the requirements of the protocol.
3. Written voluntarily given informed consent given by the subject or subject’s parent / legally acceptable representative prospectively.
|
|
| ExclusionCriteria |
| Details |
1. Subjects who did not receive a single dose of Typhoid conjugate vaccine in previous study bearing No. BECT053.
2. Subjects for whom blood samples could not be collected either at baseline or at post vaccination period in the previous study bearing No. BECT053.
3. Female subjects with UPT (Urine Pregnancy Test) positive at Visit 3 (pre-booster at Day 730).
4. History of documented hypersensitivity to any component of the vaccine.
5. History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
6. Receipt of any other investigational intervention or blood products in the last 3 months or anticipated during the course of the study.
7. Any confirmed or suspected immunosuppressive or immune-deficient condition or receipt of systemic immunosuppressant or systemic corticosteroids in the last 3 months based on medical history and physical examination;
8. Known history of diabetes, tuberculosis, cancer, chronic kidney, heart, or liver disease, progressive neurological disorders, poorly controlled seizures, or terminal illness.
9. Any condition determined by the investigator likely to interfere with evaluation of the vaccine or to be a significant potential health risk to the child or make it unlikely that the child would complete the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number and percentage of subjects with anti-Vi IgG antibodies |
At or above 12, 24 and 36 months post primary vaccination. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number and percentage of subjects with anti-Vi IgG antibodies |
At day 42 post booster dose |
| Geometric mean concentrations of anti-Vi IgG antibodies and proportion of subjects with ≥4-fold rise of antibodies |
At day 42 post booster dose |
| Number and percentage of subjects with solicited adverse reactions |
during first 30 minutes of post booster vaccination observation period and for subsequent 7 consecutive days |
| Number and percentage of subjects with unsolicited adverse events (AEs) |
during the follow up period until day 42 post booster vaccination |
| » Number and percentage of subjects with medically attended and/or serious adverse events (SAEs), if any |
during the 42 days follow up period after booster vaccination. |
|
|
Target Sample Size
|
Total Sample Size="576"
Sample Size from India="576"
Final Enrollment numbers achieved (Total)= "233"
Final Enrollment numbers achieved (India)="233" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/03/2020 |
| Date of Study Completion (India) |
23/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="2"
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
|
This is a multicentre phase-III follow-up study to assess the immunological persistence of anti-Vi IgG antibodies at or above 12, 24 and 36 months respectively. This follow up study is also designed to evaluate the immune response to a booster dose of respective typhoid Vi conjugate vaccine administered at 36 months in 6 months to 45 year old subjects who have participated in BECT053 study in both arms. A total of 576 primed 6 months to 45-year-old subjects of either gender who have successfully completed participation in a previous phase-II/III study bearing No. BECT053 would be enroled in this study. A single booster dose of respective typhoid Vi conjugate vaccine would be administered at 36 months and subjects would be followed up to day 42+7 for safety and immunogenicity assessment. The study will be conducted in compliance with schedule Y, ICH and Indian good clinical practice guidelines in force.
|