| CTRI Number |
CTRI/2009/091/000539 [Registered on: 17/07/2009] |
| Last Modified On: |
25/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Vaccine
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A phase IV clinical trial to study the safety and immunogenicity of a single booster dose of BEs Tetanus Toxoid vaccine BETT administered to 18-50 year old healthy Indian adults of either gender. |
Scientific Title of Study
Modification(s)
|
A multicentric, single blind, parallel, randomized phase-IV study to evaluate the immunogenicity & safety of a single booster dose of BEs Tetanus Toxoid vaccine BETT administered to healthy Indian adults of either gender aged between 18-50 years in comparison with the marketed ShanTT® vaccine - A non-inferiority study. |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BECT015/TT-PIV/CTP-01 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DrTSAKishore |
| Designation |
|
| Affiliation |
|
| Address |
Trial Coordinator, Biological E. Limited, 18/1&3,
Azamabad
Hyderabad
TELANGANA
500020
India |
| Phone |
04030214046 |
| Fax |
04027675003 |
| Email |
kishore.tsa@biologicale.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.T.S.A.Kishore |
| Designation |
|
| Affiliation |
|
| Address |
Trial Coordinator, Biological E. Limited, 18/1&3,
Azamabad
Hyderabad
ANDHRA PRADESH
500020
India |
| Phone |
04030214046 |
| Fax |
04027675003 |
| Email |
kishore.tsa@biologicale.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr.T.S.A.Kishore |
| Designation |
|
| Affiliation |
|
| Address |
Trial Coordinator, Biological E. Limited, 18/1&3,
Azamabad
Hyderabad
ANDHRA PRADESH
500020
India |
| Phone |
04030214046 |
| Fax |
04027675003 |
| Email |
kishore.tsa@biologicale.co.in |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
Biological E Limited |
| Address |
Biological E. Limited,18/1&3, Azamabad, Hyderabad,India-500020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.Ashok Dash |
Global Hospitals, |
6-1-1070/124, lakdikapool, ,-500004
Hyderabad
ANDHRA PRADESH |
040-23233166
dr_ashokdash@rediffmail.com |
| Dr.Kakarani |
Padmashree Dr.D.Y.Patil Pratishthan Hospital and Research Centre, |
Sant Tukaram nagar, Pimpri,-411018
Pune
MAHARASHTRA |
9823972424
kakrani@hotmail.com |
| Dr.J.M. Jeetendra kumar |
Rajarajeshwari Medical College & Hospital, |
College Campus: Kambipura, Mysore Road, Kengeri Hobli, ,-560074
Bangalore
KARNATAKA |
9880381258
drjeetendra@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Committee, Rajarajeshwari Medical College, College Campus: Kambipura, Mysore Road, Kengeri Hobli, Bangalore - 560074, India. |
Approved |
| Ethics Committee,Padmashree Dr.D.Y.Patil Medical College, Sant Tukaram nagar, Pimpri, Pune - 411018, India. |
Approved |
| Institutional Ethics Committee, Global Hospitals, 6-1-1070/124, Lakdikapool, Hyderabad-500004, India. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preventive protection against Tetanus disease. |
| Patients |
(1) ICD-10 Condition: Z23||Encounter for immunization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BE's Adsorbed Tetanus vaccine B.P. (BETT) |
0.5mL single booster dose given intramuscularly. |
| Comparator Agent |
Tetanus Toxoid vaccine (ShanTT®) |
0.5mL single booster dose given intramuscularly. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Written informed consent obtained from the subject or his/her legally acceptable representative;
2) Healthy Indian subjects of either gender aged between 18-50 yrs of age;
3) Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature >39.5 degrees);
4) History of previous immunisation with TT;
5) Subjects without any history of contagious diseases.
|
|
| ExclusionCriteria |
| Details |
1) Subjects with acute disease at the time of enrolment, defined as presence of a moderate or severe illness;
2) Clinical or serological findings suggestive of any contagious disease at the time of screening;
3) Known case of hypersensitivity to any of the components of TT vaccine;
4) Known history of any Serious Adverse Reaction (SAR) with previous TT immunizations in the individual to be immunized;
5) 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
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Non-inferiority(NI)assessment by proportions |
Non-inferiority margin set at -10% assessed after 30 days of single booster dose. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Non-inferiority (NI) by Geometric Mean titer ratio;
2. Anti-Tetanus booster responses assessed by fold increase in titers;
3. proportion of subjects seroconverted (SCR ≥0.01 IU/mL) and seroprotected (SPR ≥0.1 IU/mL).
4. Occurrence of solicited and unsolicited local and general adverse events |
1. Ratio set at > 1/1.5 assessed 30 days after single booster dose.
2. 30 days after single booster dose
3. 30 days after single booster dose.
4.first 7 days after single dose and next 28 days thereafter and serious adverse events during the entire study period. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
27/07/2009 |
| Date of Study Completion (India) |
22/09/2009 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A multicentric, single blind, parallel, randomized (2:1) phase-IV study to evaluate the immunogenicity & safety of a single booster dose of BE?s Tetanus Toxoid vaccine BETT administered to healthy Indian Adults of either gender aged between 18-50 years in comparison with the marketed ShanTT® vaccine conducted in three centres in India. The primary outcome measure is to demonstrate non-inferiority of BE?s monovalent Tetanus Toxoid vaccine (BETT) compared to ShanTT® in terms of proportion of subjects seroprotected. The secondary outcomes will be to assess non inferiority in terms of GMTs, assess booster responses, seroconversion and seroprotection rates & safety. |