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CTRI Number  CTRI/2016/01/006477 [Registered on: 04/01/2016] Trial Registered Prospectively
Last Modified On: 29/12/2020
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Vaccine 
Study Design  Single Arm Study 
Public Title of Study   A POST MARKETING SURVEILLANCE STUDY TO EVALUATE THE SAFETY OF ABHAYRAB VACCINE RECONSTITUTED TO 1 ML ADMINISTERED INTRADERMALLY IN CATEGORY II ANIMAL EXPOSURE SUBJECTS IN INDIA 
Scientific Title of Study   A PROSPECTIVE OPEN LABEL SINGLE ARM SINGLE CENTRIC POST MARKETING SURVEILLANCE STUDY TO EVALUATE THE SAFETY OF RABIES VACCINE, HUMAN I.P.(PURIFIED VERO CELL RABIES VACCINE)-ABHAYRAB VACCINE RECONSTITUTED TO 1 ML ADMINISTERED INTRADERMALLY IN CATEGORY II ANIMAL EXPOSURE SUBJECTS IN INDIA 
Trial Acronym  Abhayrab ID Study 
Secondary IDs if Any  
Secondary ID  Identifier 
HBI/RAB/IV/2014/002.01 Ver 01 Amend 01 dated 09 Sept 2015  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr S Sai Krishna 
Designation  Chief Manager 
Affiliation  Human Biologicals Institute 
Address  Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad India Telangana

Rangareddi
ANDHRA PRADESH
500032
India 
Phone  8187836444  
Fax    
Email  s.saikrishna@indimmune.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S Sai Krishna 
Designation  Chief Manager 
Affiliation  Human Biologicals Institute 
Address  Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad India Telangana


ANDHRA PRADESH
500032
India 
Phone  8187836444  
Fax    
Email  s.saikrishna@indimmune.com  
 
Details of Contact Person
Public Query
 
Name  Dr S Sai Krishna 
Designation  Chief Manager 
Affiliation  Human Biologicals Institute 
Address  Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad India Telangana


ANDHRA PRADESH
500032
India 
Phone  8187836444  
Fax    
Email  s.saikrishna@indimmune.com  
 
Source of Monetary or Material Support  
Human Biologicals Institute 
 
Primary Sponsor  
Name  Human Biologicals Institute 
Address  Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad India Telangana  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr G Sampath  Institute of Preventive Medicine  Institute of Preventive Medicine, Narayanaguda Hyderabad, Telangana- 500029
Rangareddi
ANDHRA PRADESH 
9912277002

dr.gsampath11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Directorate of Institute of Preventive Medicine Public health Labs and Food (H) Administration Narayanaguda, Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  CATEGORY II ANIMAL EXPOSURE SUBJECTS ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Rabies Vaccine, Human I.P. (Purified Vero Cell Rabies Vaccine)-Abhayrab vaccine manufactured by Human Biologicals Institute.   2-2-2-0-2 (Modified Thai Red Cross Regimen) on days 0, 3, 7 and 28 (Day ‘0’ being the day of first dose of vaccination). 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subjects with Category II Animal Exposure, aged below 70 years.
2. Plans to remain in the study area for the duration of the trial.
3. Subject/ Subject’s Legally Acceptable Representative willing to provide Informed Consent as per ICH – GCP guidelines.
4. Written informed consent for participation in the study, obtained prior to screening from Subject/Subject’s Legally Acceptable Representative.
 
 
ExclusionCriteria 
Details  1. Subjects currently receiving immunosuppressive therapy (including steroids for any indication), allergy immunotherapy or having any known immunodeficient condition (e.g. AIDS, hypogammaglobulinemia etc.) or malignancy.
2. Subjects treated with anti-malarial drug (e.g. chloroquine) in the last 2 months or requiring antimalarial treatment during the study period
3. Subjects suffering from acute febrile illness or allergic reactions including allergy to antibiotics.
4. Subjects with history of or occurrence of seizures at the time of vaccination.
5. Planned participation in another clinical trial during the present trial period.
6. Subjects who have participated in any other clinical trial within the past 3 months.
7. Subjects who have clinical evidence of significant neurological, hematological, hepatic, renal, cardiac, respiratory disease or metabolic illness.
8. Pregnant or nursing women.
9. Subjects with known hypersensitivity to the vaccine or any component of the vaccine.
10. Subjects with history of drug or alcohol abuse.
11. Subjects who received blood and/or plasma transfusion within the past 3 months.
12. Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine all the local and systemic adverse events after intradermal administration of Abhayrab Vaccine reconstituted to 1 ml.  To determine all the local and systemic adverse events after intradermal administration of Abhayrab Vaccine reconstituted to 1 ml. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "101"
Final Enrollment numbers achieved (India)="101" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   18/01/2016 
Date of Study Completion (India) 18/05/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
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  

A prospective open label, single arm,  single centric, post marketing surveillance study to evaluate the safety of Rabies vaccine, Human I.P. (Purified Vero Cell Rabies Vaccine) - Abhayrab vaccine reconstituted to 1 ml administered intradermally in Category II animal exposure subjects in India. The objective of the study is to  establish the safety of Rabies vaccine, Human I.P. (Purified Vero Cell Rabies Vaccine) - Abhayrab vaccine (reconstituted to1ml) manufactured by Human Biologicals Institute, administered intradermally, in Category II animal exposure subjects. The schedule of vaccination to be followed is 2-2-2-0-2 (Modified Thai Red Cross Regimen) on days 0, 3, 7 and 28 (Day ‘0’ being the day of first dose of vaccination). Two doses of 0.1 ml of Abhayrab vaccine (reconstituted to 1 ml) administered intradermally, one on each deltoid region as per schedule. Approximately 100 Subjects are planned to be recruited in a single centre.

 
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