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
|
|
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
|
|
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. |