| CTRI Number |
CTRI/2017/07/008976 [Registered on: 05/07/2017] Trial Registered Prospectively |
| Last Modified On: |
26/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Other |
|
Public Title of Study
|
Phase III Clinical Trial of Rabies Vaccine Human I.P. in post bite subjects. |
|
Scientific Title of Study
|
"Clinical Trial Protocol for Evaluation of Immunogenicity and Safety of Rabies Vaccine Human (Cell Culture) I.P. in post exposure subjects" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version No. 01,amendment No: 02 dt 20/08/2014 |
Protocol Number |
| Rabies/CT/POST Version no.01 dated 15/07/2010 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Atul Kakar |
| Designation |
Principal Investigator |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Sir Ganga Ram Hospital Marg ,Rajinder Nagar New Delhi.
New Delhi
DELHI
110060
India |
| Phone |
09811110802 |
| Fax |
|
| Email |
atulkakar@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Kakar |
| Designation |
Principal Investigator |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Sir Ganga Ram Hospital Marg ,Rajinder Nagar New Delhi.
DELHI
110060
India |
| Phone |
09811110802 |
| Fax |
|
| Email |
atulkakar@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SPGarg |
| Designation |
Managing Director |
| Affiliation |
Biomed Private Limited |
| Address |
C-96,Bulandshahr Road Indl.Area
Ghaziabad
Ghaziabad
UTTAR PRADESH
201009
India |
| Phone |
0120-4159857 |
| Fax |
0120-2700825 |
| Email |
saryugarg@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Biomed Private Limited
C-96,B.S. Road Industrial Ghaziabad (U.P.)-201009 |
|
|
Primary Sponsor
|
| Name |
Biomed Private Limited |
| Address |
C-96,Bulandshahr Road Industrial Area,Ghaziabad 201009,U.P.,INDIA |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Atul KakarSenior consultantDepartment of internal medicine |
Sir Ganga Ram Hospital |
Sir Ganga Ram Hospital Marg,Rajinder Nagar
New Delhi
DELHI |
9811110802
atulkakar@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sir Ganga Ram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
dog bite volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SURE RAB |
Group I: five intramuscular injection of 1ml each on days 0,3,7,14,28.
Group II: Thai Red Cross Rsgimen of intradermal injection of 0.1ml at two location on days 0,3,7,28.
|
| Comparator Agent |
VERORAB |
Group III: five intramuscular injection of 1 dose(0.5ml) each on days 0,3,7,14,28. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject is bitten by suspect rabid animal and having either category II or III exposure as assessed by history,physical examination and clinical judgment of the investigator.
2.Subject is of age group (2 to 65)years.
3.Subject is of Indian origin and will remain in the study area for the length of the trial.
4.Subject should accept written and inform consent.
5.Subject is aware of full information regarding the vaccine and clinical trial. |
|
| ExclusionCriteria |
| Details |
1.History of allergy or hypersensitivity to any component of the vaccine.
2.History of Rabies immunization.
3.Person participating in any other study at the same time or during the past three months.
4.Surgery planned during the study period.
5.Person known to be HIV positive.
6. Pregnant women.
7.Infants and children ≤2 years of age. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Immunogenicity and safety profile will be evaluated and compared with that of the reference vaccine in the study population by estimating the percentage seroconversion.The seroconversion in the subjects will be evaluated. |
The rabies antibody titers shall be analysed for seroconversion(≥ 0.5 IU/ml) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NONE |
NONE |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2017 |
| Date of Study Completion (India) |
06/11/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Results of phase III trial is under review for publication. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The purpose of this Clinical Trial was to compare Immunogenicity and safety of Rabies Vaccine Sure Rab manufactured by Biomed Private Limited with the Vero Rab manufactured by Aventis Pasteur in post exposure subjects.
Objectives:
1. For Evaluation of Immunogenicity and safety of Rabies Vaccine Human (Cell Culture) I.P. in post exposure subjects.
2. Subjects were divided into three groups:- 1. Group I : Immunized by Essen regimen with Sure Rab. 2. Group II: Immunized by Thai Red Cross regimen Sure Rab. 3. Group III: Immunized by Essen regimen with Vero Rab. All volunteers of test and comparator vaccine achieved the protective level on Day 14. Results were submitted to DCGI and sale permission is granted by DCGI. |