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

Not Applicable

Completed

• Conditions: CATEGORY II ANIMAL EXPOSURE SUBJECTS

• Registration Number: CTRI/2016/01/006477
• Lead Sponsor: Human Biologicals Institute

Brief Summary

A prospectiveopen label, single arm,  single centric,post marketing surveillance study to evaluate the safety of Rabies vaccine, HumanI.P. (Purified Vero Cell Rabies Vaccine) - Abhayrab vaccine reconstituted to 1ml administered intradermally in Category II animal exposure subjects in India. The objective of the study is to  establish thesafety of Rabiesvaccine, Human I.P.(Purified Vero Cell Rabies Vaccine) - Abhayrab vaccine (reconstitutedto1ml) manufacturedby 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 dayof first dose of vaccination). Two doses of 0.1 ml of Abhayrabvaccine (reconstituted to 1 ml) administered intradermally, one oneach deltoid region as per schedule. Approximately100 Subjects are planned to be recruited in a single centre.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-18
• Study Completion: 2016-05-18
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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 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.

Trial Locations

Locations (1)

Institute of Preventive Medicine; 🇮🇳 Rangareddi, ANDHRA PRADESH, India

Institute of Preventive Medicine

🇮🇳Rangareddi, ANDHRA PRADESH, India

Dr G Sampath

Principal investigator

9912277002

dr.gsampath11@gmail.com