| CTRI Number |
CTRI/2018/07/014919 [Registered on: 17/07/2018] Trial Registered Prospectively |
| Last Modified On: |
06/09/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Phase II/III clinical study to assess the immunogenicity and safety of Tetanus Vaccine (adsorbed) |
|
Scientific Title of Study
|
A Phase II/III, Multicenter, Randomized, Single Blind Clinical Study to Compare the Immunogenicity and Safety of Tetanus Vaccine (Adsorbed) of M/S Seasons Biologicals Pvt Ltd with Tetanus Vaccine (Adsorbed) of M/S Serum Institute of India Ltd In Healthy Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SBPL-TT-02-2017 Version 1.0 18/05/2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R Arulprakash |
| Designation |
Director Clinical Operations |
| Affiliation |
Seasons Biologicals Pvt Ltd |
| Address |
302, Skill Spectrum, 3/6/369, Liberty Junction, Himayathnagar, Hyderabad
Rangareddi
ANDHRA PRADESH
500029
India |
| Phone |
040-23220302 |
| Fax |
|
| Email |
arulprakash.r@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S V Kotbagi |
| Designation |
Cheif Operating Officer |
| Affiliation |
Seasons Biologicals Pvt Lyd |
| Address |
302, Skill Spectrum, 3/6/369, Liberty Junction, Himayathnagar, Hyderabad
Rangareddi
ANDHRA PRADESH
500029
India |
| Phone |
040-23220302 |
| Fax |
|
| Email |
kotbagi@seasonsgroup.in |
|
Details of Contact Person
Public Query
|
| Name |
Hruday Kumar Reddy |
| Designation |
Director |
| Affiliation |
Seasons Biologicals Pvt Ltd |
| Address |
302, Skill Spectrum, 3/6/369, Liberty Junction, Himayathnagar, Hyderabad
Rangareddi
ANDHRA PRADESH
500029
India |
| Phone |
040-23220302 |
| Fax |
|
| Email |
hruday@seasonsgroup.in |
|
|
Source of Monetary or Material Support
|
| Seasons Biologicals Pvt Ltd,
#302, Skill Spectrum, 3-6-369,
Liberty Junction, Himayathnagar,
Hyderabad - 500029 |
|
|
Primary Sponsor
|
| Name |
Seasons Biologicals Pvt Ltd |
| Address |
302, Skill Spectrum, 3-6-369,
Liberty Junction, Himayathnagar,
Hyderabad – 500029
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijaykumar Shivajirao Patil |
Apple Saraswati Multispecialty Hospital |
804/2, 805/2, Circuit House to Kadamwadi Road, Bhosalewadi, Kolhapur – 416003
Kolhapur
MAHARASHTRA |
09158592177
02312688888
clinicalresearchgoa@gmail.com |
| Dr VCSrinivas Reddy |
King George Hospital |
Andhra Medical College
Visakhaptanam – 530002
Visakhapatnam
ANDHRA PRADESH |
08912510215
kghresearch7@gmail.com |
| Dr Deo Nidhi Mishra |
Nirmal Hospital |
Opposite MLB Medical College,
Gate Number 3,
Jhansi - 284128
Jhansi
UTTAR PRADESH |
05102321001
drmishra.nirmal@gmail.com |
| Dr Paruchuri Anil Kumar |
Praveen Hospital |
Praveen Cardiac Centre
No 32-9-18, Moghalrajapuram, Madhu Garden Centre, No.5 bus route, Vijayawada – 520010
Krishna
ANDHRA PRADESH |
09848527270
bioexperts21@gmail.com |
| Dr B Srinivasa Rao |
Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital |
Department of General Medicine,
Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital,
Srikakulam-532001
Srikakulam
ANDHRA PRADESH |
08942279033
rimsresearch@gmail.com |
| Dr Minesh Mehta |
Shalby Hospitals |
Opposite to Karnavati Club, S.G. Highway, Ahmedabad - 3800115
Ahmadabad
GUJARAT |
07940203000
info.sg@shalby.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Apple Saraswati Multispeciality Hospital Institutional Ethics Committee |
Approved |
| Ethics Committee Shalby Limited, Krishna Shalby Hospital |
Submittted/Under Review |
| Ethics Committee,Nirmal Hospital |
Approved |
| Institutional Ethics Committee Praveen Hospital, Praveen Cardiac Centre |
Approved |
| Institutional Ethics Committee, King George Hospital |
Submittted/Under Review |
| Rajiv Gandhi Institute of Medical Sciences & RIMS GGH |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Immunization against Tetanus |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tetanus Vaccine (Adsorbed) of Seasons Biologicals Pvt Ltd |
Tetanus Vaccine (Adsorbed) of Seasons Biologicals Pvt Ltd |
| Comparator Agent |
Tetanus Vaccine (Adsorbed) of Serum Institute of India Ltd |
Tetanus Vaccine (Adsorbed) of M/S Serum Institute of India Ltd |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy subjects of either gender, between 10-45 years of age who give written informed consent prior to the study entry. Children and adolescent (between the age group of 10 -17) having signed the assent consent form
2. Subject with clean minor wound(s) who had been warranted for receiving Tetanus Toxoid (Adsorbed)
3. Willingness to adhere to the study requirements
4. Subjects with good health as determined by:
Medical history, Physical examination, Clinical judgment of the investigator and Clinical laboratory examination (subjects with clinically acceptable range during baseline screening)
|
|
| ExclusionCriteria |
| Details |
1. Administration of immunoglobulin or blood or any blood products since birth.
2. Use of any investigational or un-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the study vaccination.
3. Subjects who had received any vaccines 6 months prior to study entry
4. Subjects with history of administration of any tetanus toxoid containing vaccine within the past 5 years
5. Previous evidence of Tetanus.
6. History of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics
7. Major congenital or hereditary immunodeficiency.
8. Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 7 days or planned administration during the study period.
9. Subjects with febrile illness (temperature > 38 degree centigrade) at the time of enrollment
10. Subjects who have received cytotoxic agents or radiotherapy within last month
11. Evidence of disease or history of allergic disease or persistent hematological, hepatic, renal, cardiac or respiratory disease and signs of a CNS disorder at the time of vaccination or with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives
12. Subjects having history or presence of drug abuse or alcoholism within one year prior to study entry
13. Subjects having history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products
14. Subjects having difficulty in donating blood and Subjects who have donated blood within the past 3 months
15. Pregnant and nourishing women
16. Subjects who are planning to leave the area of the study site before the end of the study period.
17. Any other condition which in the opinion of the investigator will jeopardize the safety of the subject due to participation in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the Immunogenicity of Tetanus Vaccine (Adsorbed) of M/S Seasons Biologicals Pvt Ltd in comparison with the
commercially available Tetanus Vaccine (Adsorbed) of M/S Serum
Institute of India Ltd |
28 days following vaccination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety and tolerability of the Tetanus Vaccine (Adsorbed) of Seasons Biologicals Pvt Ltd |
28 days following vaccination |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
23/07/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an randomized, single blind, comparative, multicenter, prospective clinical study, designed to assess the immunogenicity and safety of Tetanus Toxoid (Adsorbed) vaccine developed by Seasons Biologicals Pvt Ltd in comparison with commercially available Tetanus Toxoid (Adsorbed) of Serum Institute of India Ltd in healthy subjects.
Approximately 180 subjects will be enrolled in this study. Consenting subjects meeting the eligibility criteria of the study will be randomized in a 2:1 ratio to receive single dose of 0.5 ml of Seasons Biologicals Pvt Ltd vaccine OR Serum Institute of India Ltd vaccine, deep intramuscularly into the deltoid region.
Immunogenicity and safety of the vaccine will be assessed after 28 days of vaccination. |