| CTRI Number |
CTRI/2013/09/004032 [Registered on: 30/09/2013] Trial Registered Prospectively |
| Last Modified On: |
25/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine
Biological
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A post licensure study to evaluate the immunogenicity & safety of a single booster dose of BEs Tetanus reduced Diphtheria (Td) Vaccine in healthy ≥7 year old Indian children, adolescents and adults in comparison with a marketed Td vaccine. |
|
Scientific Title of Study
|
A Multicentre, Open label, randomised, phase-IV study to evaluate the immunogenicity & safety of a single booster dose of BEs Tetanus Diphtheria (Td) vaccine (adsorbed) administered to healthy Indian children ≥7 years, Adolescents and Adults who received primary immunisation as compared with a marketed Diphtheria and Tetanus (Td) vaccine |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BECT024/Td-PIV/CTP-01 Version no:01 dated 01.09.12 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr TSA Kishore |
| Designation |
General Manager |
| Affiliation |
Biological E. Limited |
| Address |
Biological E.Limited, 18/1&3, Azamabad
Hyderabad
ANDHRA PRADESH
India
Biological E.Limited, 18/1&3, Azamabad
Hyderabad
ANDHRA PRADESH
500020
India
Hyderabad
ANDHRA PRADESH
500020
India |
| Phone |
04030214046 |
| Fax |
04027675003 |
| Email |
kishore.tsa@biologicale.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr TSA Kishore |
| Designation |
General Manager |
| Affiliation |
Biological E. Limited |
| Address |
Biological E.Limited, 18/1&3, Azamabad
Hyderabad
ANDHRA PRADESH
India
Biological E.Limited, 18/1&3, Azamabad
Hyderabad
ANDHRA PRADESH
500020
India
Hyderabad
ANDHRA PRADESH
500020
India |
| Phone |
04030214046 |
| Fax |
04027675003 |
| Email |
kishore.tsa@biologicale.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Shekhar Gupta |
| Designation |
Chief Operating Officer |
| Affiliation |
D2L Pharma Research Solutions |
| Address |
D2L Pharma Research Solutions,
1st Floor, Nandi Infotech, KIADB Plot # 8,
1st Cross, Sadaramangala Industrial Area,
Mahadevpura Post, Bangalore, Karnataka
D2L Pharma Research Solutions,
1st Floor, Nandi Infotech, KIADB Plot # 8,
1st Cross, Sadaramangala Industrial Area,
Mahadevpura Post, Bangalore, Karnataka, India.560048
Bangalore
KARNATAKA
560048
India |
| Phone |
09741111101 |
| Fax |
08030850667 |
| Email |
shekhar.gupta@d2lpharma.com |
|
|
Source of Monetary or Material Support
|
| Biological E.Limited 18/1&3, Azamabad, Hyderabad, Andhra Pradesh-500020.India |
|
|
Primary Sponsor
|
| Name |
Biological E Limited |
| Address |
Biological E.Limited 18/1&3, Azamabad, Hyderabad, Andhra Pradesh-500020.India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Haridas Upadya |
Aadithya Adhikari Hospital |
Aadithya Adhikari Hospital,Contour Road,Gokulam,Mysore-570002
Mysore
KARNATAKA |
09880046375
dr.upadya@gmail.com |
| Dr M A Shekhar |
K.R.Hospital |
K.R.Hospital,
Mysore Medical College & Research Institute,Irwin Road,
Mysore- 570001, Karnataka, India.
Mysore
KARNATAKA |
09845120106
drsheki@gmail.com |
| Dr V V Satyanarayana |
King George Hospital |
King George Hospital(KGH)
Near Collectorate,
Maharanipeta,
Visakhapatnam-530002
Visakhapatnam
ANDHRA PRADESH |
09848022894
satyanarayana.vempolu@gmail.com |
| Dr Rahul Dosi |
Oyster and Pearl Hospital |
Oyster and Pearl Hospital
1671-75, Ganesh Khind Road
Near Hotel Pride, Shivaji Nagar
Pune-411005,
Pune
MAHARASHTRA |
09850038032
drrahuldosi@hotmail.com |
| Dr Prakash Joshi |
Sant Dnyaneshwar Medical Education & Research Centre |
Sant Dnyaneshwar Medical Education & Research Centre,
Opp.Vijay Cinema,Laxmi Road,Pune-411 030
Pune
MAHARASHTRA |
09822874373
pvjoshi2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee Mysore Medical College and Research Institute and Associated Hospitals(K R Hospital) |
Approved |
| Institutional Ethics Committee (King George Hospital) |
Approved |
| Mysore Clinical Research centre Ethics Committee (Aadhitya Adhikari Hospital) |
Approved |
| O & P Institutional Ethics Committee (Oyster & Pearl Hospital) |
Approved |
| Sant Dnyaneshwar Medical Education Research Centre Institutional Review Board |
Approved |
| Sri Venkateshwara Hospital Ethics Committee (Sri Venkateshwara Hospital) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
For active immunization for the prevention of disease caused by Tetanus and Diphtheria. |
| Patients |
(1) ICD-10 Condition: Z23||Encounter for immunization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BE Td Vaccine |
0.5mL administered intramuscularly as a single booster dose on 0 day. |
| Comparator Agent |
Sii Td-Vac Vaccine |
0.5mL administered intramuscularly as a single booster dose on 0 day. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Written informed consent from the subject or subject’s parent/guardian or subject’s legally acceptable representative
2.Informed assent directly from the child/adolescent aged between ≥7 to <18 years in addition to consent from subject or his/her LAR, except when the subject is incapable of providing it because of immaturity or cognitive abilities as judged by the Investigator.
3.Healthy Indian subjects of either gender between ≥7 to <18 years in child/adolescent age subset and ≥18 years of age in adult age subset at the time of vaccination.
4.Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature >103.5°F [>39.5°C]).
5.History of previous primary immunisation with DTP vaccine at childhood.
6.Willingness of subject or subject’s parent/guardian or their legally acceptable representative not to participate in any other clinical trial during the course of study.
7.Subject or subject’s parent/guardian or subject’s legally acceptable representative willing to comply with the protocol requirements.
8.Subjects who were not receiving any immunosuppressive therapy.
9.Subjects without contraindications or precautionary circumstances.
|
|
| ExclusionCriteria |
| Details |
1.History of Tetanus (TT) or Tetanus with reduced diphtheria (Td) booster vaccination within last 5 years.
2.Subjects with acute disease at the time of enrolment, defined as “presence of a moderate or severe illnessâ€.
3.Life-threatening or serious cardiac, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematologic or immunologic disorder.
4.Subjects with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection.
5.Pregnant women and women with childbearing potential not following proven contraceptive methods.
6.Subjects on immunosuppressive or immunostimulant therapy.
7.Any confirmed or suspected immunosuppressive or immunodeficient condition.
8.Known case of hypersensitivity to any of the components of Td vaccine.
9. Known history of any serious adverse reaction/event (SAR/SAE) with previous Tetanus and Diphtheria immunizations.
10.Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Number and percentage of subjects achieving seroprotection levels of anti-Tetanus and anti-Diphtheria antibodies.
2.Two sided 95% confidence intervals for the difference in proportions of subjects achieving seroprotection rates of anti-Tetanus and anti-Diphtheria antibody titres |
1.At day 30 in both the treatment arms across target age subsets
2.At day 30 post single booster dose |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Geometric Mean Titres (GMT)
2.Two fold and four fold rise in anti-Tetanus and anti-Diphtheria antibody titres.
3.Occurrence of solicited local adverse events
4.Occurrence of both solicited and unsolicited local and systemic adverse events (AEs)
5.Occurrence of serious adverse events (SAEs) |
1.At day 30 estimated in both treatment arms across targeted age subsets and compared
2. 30 days after the booster dose
3.Within 30 minutes post vaccination
4.a. During 7-day (Day 0-6) follow up period after single booster dose
4.b.During the subsequent follow up period from Day 7 to day 30
5.Over the entire course of the study |
|
|
Target Sample Size
|
Total Sample Size="270"
Sample Size from India="270"
Final Enrollment numbers achieved (Total)= "270"
Final Enrollment numbers achieved (India)="270" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/10/2013 |
| Date of Study Completion (India) |
04/01/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
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, open label, parallel, randomized (2:1) phase-IV non-inferiority study.There will be a total of 270 healthy subjects of either sex who will be randomised into two treatment arms viz., BE’s Td vaccine group and SIIL’s Td vaccine group. There would be two age subsets in each of the treatment arms. Healthy children, adolescents between ≥7 to <18 years of age would be enrolled in group-1 and healthy adults of ≥18 years of age would be enrolled in group-2 in both treatment arms.
The objective of this phase-IV study is to assess the immunogenicity and safety of BE’s licensed Td vaccine (BE Td®) in ≥ 7 year old children, adolescents and adults of either gender in comparison with SIIL’s licensed (Sii Td-Vac™) vaccine. This vaccine to be administered intramuscularly in a single booster dose schedule.
Antibody titre estimation and rotuine laboratory investigations will performed twice during the study i.e., once before administration of the booster dose and again 30 days after the administration of booster dose.
|