study to examine long-term immunogenicity and safety of VaxiRab N® (Rabies vaccine) in patients with animal bites

Phase 4

Not yet recruiting

Conditions: Contact with dog, (2) ICD-10 Condition: W53||Contact with rodent,

Brief Summary: Rabies is a fatal disease causing around 55,000 deaths annually, with India reporting nearly 20,000 deaths and 17 million animal bites each year. This Phase IV trial assesses the long-term safety and immunogenicity of VaxiRab N® compared to a WHO pre-qualified rabies vaccine in individuals with category II and III bites. The study evaluates both IM and ID administration routes in pre and post exposure bite cases.

Recruitment & Eligibility

Inclusion Criteria

1. Participants with age 3.
45 years and category II or III animal bites 2. Those who provide informed consent (participants [Greater than or equals to 18 years] and parents of participants [3.
less than 18] years) and willing to be followed up for at least 360 days after first vaccination. Additional assent in case of children aged 7.
less than 18 years 3. Participants or parents of participants with adequate literacy to fill the diary Category II.
nibbling of uncovered skin, minor scratches or abrasions without bleeding, licks on broken skin Category III.
single or multiple transdermal bites or scratches, contamination of mucous membrane with saliva from licks; exposure to bat bites or scratches Note: All ages will be calculated in completed years.

Exclusion Criteria

History of anaphylaxis or serious reactions to other vaccines 2.
Received any type of rabies vaccine or any dose of rabies immunoglobulin in the past 3.
History of suturing of the wound or application of irritants at the wound site 4.
History of serious chronic illness, or immunosuppression (immunosuppressive illness or therapy) or on steroids 5.
Treated with antimalarial drugs in last 2 months 6.
Participants with acute febrile illness (body temperature Greater than or equals to 37.5°C) at the time of enrolment 7.
Participants with clinically significant systemic disorder, such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological, or immunological disorder 9.
Pregnant or lactating women or those who are planning to become pregnant in the next 1 year 10.
Any other vaccine administration within 30 days of initiation of the study 11.
Participation in any clinical trial in the last 3 months 12.
Patient with history of drug or alcohol abuse.

Primary Outcome Measures

Name	Time	Method
To evaluate the immunogenicity of VaxiRab N® (Rabies vaccine) in comparison to a WHO prequalified rabies vaccine in category II and category III animal bite cases Note: 5 doses intramuscularly or 4 doses intradermally for both VaxiRab N® (Rabies vaccine) and WHO prequalified vaccine	Week 4

Secondary Outcome Measures

Name	Time	Method
Immunogenicity	To evaluate the immunogenicity of VaxiRab N® (Rabies vaccine) in comparison to a WHO prequalified rabies vaccine in category II and category III animal bite cases.

Locations (7): GMERS Medical College and Hospital
🇮🇳
Vadodara, GUJARAT, India
Government Medical College and Government General Hospital
🇮🇳
Srikakulam, ANDHRA PRADESH, India
Hi-Tech Medical College & Hospital
🇮🇳
Khordha, ORISSA, India
Institute of Medical Sciences & SUM Hospital
🇮🇳
Khordha, ORISSA, India
M.K.C.G. Medical College and Hospital
🇮🇳
Ganjam, ORISSA, India
Marwari Hospitals & Research Centre
🇮🇳
Kamrup, ASSAM, India
Nobel Hospital Pvt. Ltd.
🇮🇳
Pune, MAHARASHTRA, India
GMERS Medical College and Hospital
🇮🇳Vadodara, GUJARAT, India
Dr Amul N Bhedi
Principal investigator
9426569629
amul_bhedi@yahoo.com