A POST MARKETING SURVEILLANCE STUDY TO EVALUATE THE SAFETY OF ABHAYRAB VACCINE RECONSTITUTED TO 1 ML, ADMINISTERED IN CATEGORY II ANIMAL EXPOSURE SUBJECTS IN INDIA
- Conditions
- Health Condition 1: null- CATEGORY II ANIMAL EXPOSURE SUBJECTS
- Registration Number
- CTRI/2016/01/006482
- Lead Sponsor
- Human Biologicals Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
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/ Subjectâ??s Legally Acceptable Representative willing to provide Informed Consent as per ICH â?? GCP guidelines.
4.Written informed consent for participation in the study, obtained prior to screening from Subject/ Subjectâ??s Legally Acceptable Representative.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine all the local and systemic adverse events in both arms.Timepoint: To determine all the local and systemic adverse events in both arms after each dose of vaccination till 7 days after the last dose of vaccination.
- Secondary Outcome Measures
Name Time Method ilTimepoint: Not applicable