study to assess the safety and immune response of VaxiRab N® (rabies vaccine) for prophylaxis against rabies.

Phase 4

Not yet recruiting

• Conditions: Encounter for prophylactic immunotherapy,

• Registration Number: CTRI/2025/06/088685
• Lead Sponsor: Zydus Lifesciences Limited

Brief Summary

An open-label, multicentre,phase IV clinical study to assess the safety and immunogenicity of VaxiRab N®administered for prophylaxis against rabies.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-23
• Last Update Posted: 2025-06-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• 1. Healthy subjects for pre-exposure prophylaxis or subjects with WHO category II or III animal bites for post-exposure prophylaxis against rabies 2. Written informed consent and assent (if applicable) from adult subjects or parents of minor subjects (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.

Exclusion Criteria

• History of anaphylaxis or serious reactions to other vaccines 2.
• History of suturing of the wound or application of irritants at the wound site 3.
• Participants with any clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological, or immunological disorder 4.
• History of any serious chronic illness or immunosuppression (immunosuppressive illness or therapy) or on steroids 5.
• Subjects with any acute febrile illness (body temperature greater than or equals to 37.5°C) at the time of enrolment 6.
• Pregnant or lactating women or planning to become pregnant in the next one year 7.
• Participation in any clinical trial in the last 3 months 8.
• Patient with history of drug or alcohol abuse 9.
• Received any type of rabies vaccine or any dose of rabies immunoglobulin in the past 10.
• Treated with antimalarial drugs in last 2 months 11.
• Any other vaccine administration within 30 days of initiation of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the safety profile of VaxiRab N® administered for prophylaxis against rabies	Week 1, Week 2, Week 4

Secondary Outcome Measures

Name	Time	Method
To evaluate the immunogenicity of VaxiRab N® in a subset of 10 percent of subjects

Trial Locations

Locations (28)

Aatman Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Artemis Hospital; 🇮🇳 Gurgaon, HARYANA, India

Belagavi Institute of Medical Sciences; 🇮🇳 Belgaum, KARNATAKA, India

BHS Lakeview Hospital; 🇮🇳 Belgaum, KARNATAKA, India

Care Multi Speciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Department of Community Medicine and Family Medicine, All India Institute of Medical Sciences; 🇮🇳 Khordha, ORISSA, India

Department of Community Medicine ESIC Medical College and Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Department of Medicine, Institute of Medical Science; 🇮🇳 Khordha, ORISSA, India

GMERS Medical College and Hospital Gotri; 🇮🇳 Vadodara, GUJARAT, India

Government Medical College and Government General Hospital; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Scroll for more (18 remaining)

Aatman Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Chintan Patel

Principal investigator

9825182251

drchintan.cr@gmail.com