| CTRI Number |
CTRI/2015/05/005740 [Registered on: 05/05/2015] Trial Registered Prospectively |
| Last Modified On: |
14/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study to evaluate and compare the immunogenicity and safety of Tetanus vaccine of Cadila Healthcare Ltd. vs Tetanus vaccine of Serum Institute of India Ltd. in healthy subjects and subjects with clean minor wounds |
|
Scientific Title of Study
|
A prospective, randomized, two arm, single blind, parallel, active controlled, multicentre, non-inferiority, phase II/III clinical study to evaluate the immunogenicity and safety of Tetanus vaccine (adsorbed) of M/s Cadila Healthcare Limited compared to Tetanus vaccine (adsorbed) of M/s Serum Institute of India Limited in healthy subjects and subjects with clean minor wounds |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 14-03; Version No. 00; Dated 08.05.2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
Cadila Healthcare Ltd. |
| Address |
Cadila Healthcare Ltd.,
Zydus-PTC, Sigma Commerce Zone,
B/H ISCON Temple, Near Satellite Cross Roads,
Ambli-Bopal Road, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868926 |
| Fax |
079-26868910 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
Cadila Healthcare Ltd. |
| Address |
Cadila Healthcare Ltd.,
Zydus-PTC, Sigma Commerce Zone,
B/H ISCON Temple, Near Satellite Cross Roads,
Ambli-Bopal Road, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868926 |
| Fax |
079-26868910 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavankumar Daultani |
| Designation |
Manager – New Product Development |
| Affiliation |
Cadila Healthcare Ltd. |
| Address |
Cadila Healthcare Ltd.,
Zydus-PTC, Sigma Commerce Zone,
B/H ISCON Temple, Near Satellite Cross Roads,
Ambli-Bopal Road, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868937 |
| Fax |
079-26868910 |
| Email |
pavankumar.daultani@zyduscadila.com |
|
|
Source of Monetary or Material Support
|
| Cadila Healthcare Ltd., Zydus-PTC, Sigma Commerce Zone, B/H ISCON Temple, Near Satellite Cross Roads, Ambli-Bopal Road, Ahmedabad - 380015, Gujarat |
|
|
Primary Sponsor
|
| Name |
Cadila Healthcare Ltd |
| Address |
Cadila Healthcare Ltd.,
Zydus-PTC, Sigma Commerce Zone,
B/H ISCON Temple, Near Satellite Cross Roads,
Ambli-Bopal Road, Ahmedabad - 380015 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradeep N |
Cheluvamba Hospital, Mysore |
Immunization Room, Ground floor, OPD building, Cheluvamba Hospital, Mysore Medical College and Research Institute
Mysore
KARNATAKA |
09611898080
drpradeepn80@yahoo.com |
| Dr Jigar Indravadan Gami |
GMERS Medical College & Civil Hospital, Ahmedabad |
Room No. 1, Transit OPD, Ground floor, Department of Medicine, GMERS Medical College & Civil Hospital, Sola, S.G. Highway, Near New Gujarat High Court
Ahmadabad
GUJARAT |
09898158998
drjigargami@yahoo.co.in |
| Dr Chirag Rathod |
GMERS Medical College & General Hospital, Vadodara |
Department of Medicine, 6th floor, GMERS Medical College & General Hospital, Gotri, Gotri road
Vadodara
GUJARAT |
09909035630
chirag_rthd@rediffmail.com |
| Dr Uma Nayak |
GMERS Medical College & General Hospital, Vadodara |
Room No. 501, 5th Floor, Department of Pediatrics, GMERS Medical College & General Hospital, Gotri, Gotri road
Vadodara
GUJARAT |
09327214065
umasnayak@gmail.com |
| Dr Sanjay Kumar Jangid |
Hi-Tech Medical College and Hospital, Bhubaneshwar |
Department of Medicine, Hi-Tech Medical College and Hospital, Health Park, Pandara, Rasulgarh, Bhubaneshwar
Khordha
ORISSA |
09337671521
drsanjay_jangid@yahoo.co.in |
| Dr Ritabrata Kundu |
Institute of Child Health, Kolkata |
Room No. 113, Ground floor, Institute of Child Health, 11, Dr. Biresh Guha Street
Kolkata
WEST BENGAL |
09831194865
rkundu22@gmail.com |
| Dr Paramesh K C |
K R Hospital, Mysore |
Room No. 3, Orthopedic OPD, K.R. Hospital, Mysore Medical College and Research Institute
Mysore
KARNATAKA |
09343055819
parameshkennal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethics Committee - Institute of Child Health, 11, Dr. Biresh Guha Street, Kolkata – 700017 |
Approved |
| Ethics Committee, GMERS Medical College Sola, S.G. Highway, Near New Gujarat High Court, Ahmedabad-380061, Gujarat, India |
Approved |
| Institutional Ethics Committee, Hi-Tech Medical College and Hospital, Health Park, Pandara, Rasulgarh, Bhubaneshwar |
Approved |
| Institutional Ethics Committee, Mysore Medical College and Research Institute and Associated Hospitals, Irwin Road, Mysore - 570021, Karnataka |
Approved |
| Institutional Ethics Committee, Mysore Medical College and Research Institute and Associated Hospitals, Irwin Road, Mysore - 570021, Karnataka |
Approved |
| Institutional Human Ethics Committee (Institutional Review Board), GMERS Medical College Gotri, Gotri road, Vadodara-390021, Gujarat, India |
Approved |
| Institutional Human Ethics Committee (Institutional Review Board), GMERS Medical College Gotri, Gotri road, Vadodara-390021, Gujarat, India |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Booster immunization for the prevention of Tetanus in healthy subjects & subjects with clean minor wounds |
| Patients |
(1) ICD-10 Condition: Z23||Encounter for immunization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tetanus vaccine (adsorbed) of M/s Cadila Healthcare Ltd |
Subject will receive 0.5 ml single dose of Tetanus vaccine (adsorbed) administered as deep intramuscular injection in the deltoid muscle in the upper arm on day 0. The subject will be followed up till Day 28 post-vaccination |
| Comparator Agent |
Tetanus vaccine (adsorbed) of M/s Serum Institute of India Ltd. |
Subject will receive 0.5 ml single dose of Tetanus vaccine (adsorbed) administered as deep intramuscular injection in the deltoid muscle in the upper arm on day 0. The subject will be followed up till Day 28 post-vaccination |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy subject or subject with clean minor wound(s) of either gender between 10-40 years
2. History of previous immunization with tetanus toxoid containing vaccine
3. Written informed consent from adult subjects; or assent from adolescent subject in addition to written informed consent from subject’s legally acceptable representative
4. Adult subject or legally acceptable representative of adolescent subject literature enough to fill the diary card |
|
| ExclusionCriteria |
| Details |
1. Past history of hypersensitivity reaction, neurological disorder or any serious adverse event to any component of tetanus toxoid containing vaccine including thiomersal (a mercury derivative) and 2-Phenoxyethanol
2. Past history of tetanus
3. Subjects with history of administration of any tetanus toxoid containing vaccine within the past 5 years
4. Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
5. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
6. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
7. History of any acute illness within the last 1 week
8. Subjects with febrile illness (temperature ≥ 38oC) at the time of enrollment
9. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
10. Any other parenteral vaccine administration within the last 30 days
11. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
12. Participation in another clinical trial in the past 3 months
13. Subjects with history of alcohol or drug abuse in the past one year |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects with sero-protective levels of anti-tetanus antibodies 28 days post-vaccination |
28 days following vaccination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects with booster response to tetanus toxoid 28 days post-vaccination |
28 days following vaccination |
| Geometric mean titre of anti-tetanus antibodies at baseline and 28 days post-vaccination |
28 days following vaccination |
|
|
Target Sample Size
|
Total Sample Size="282"
Sample Size from India="282"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="283" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
07/05/2015 |
| Date of Study Completion (India) |
03/09/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized, single blind, parallel, active controlled, non-inferiority, multicentre clinical trial to evaluate and compare the immunogenicity and safety of Tetanus vaccine (adsorbed) of M/s Cadila Healthcare Ltd. with Tetanus vaccine (adsorbed) of M/s Serum Institute of India Ltd. in healthy subjects and subjects with clean minor wounds. Blood samples will be collected pre-vaccination (day 0) & post-vaccination (day 28) to determine anti-tetanus antibody titre. The primary objective of this study is to demonstrate the non-inferiority of test vaccine to the reference vaccine for proportion of subjects with sero-protective levels of anti-tetanus antibodies post-vaccination. The sero-protective cut-off titre for serum anti-tetanus antibodies is 0.1 IU/ml. The booster response to vaccination will be considered as per following criteria: Post-vaccination titre of ≥ 0.4 IU/ml for individuals with pre-vaccination antibody concentrations of < 0.1 IU/ml or; Four fold or greater antibody rise post-vaccination for participants with pre-vaccination antibody concentrations ≥ 0.1 IU/ml but < 2 IU/ml or; Two fold or greater antibody response post-vaccination for participants with pre-vaccination antibody levels ≥ 2 IU/ml. The safety of the vaccine will be assessed by recording the adverse events occurring during the entire course of the study. |