CTRI/2025/06/088886 [Registered on: 16/06/2025] Trial Registered Prospectively
Last Modified On:
30/08/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine
Study Design
Other
Public Title of Study
study to examine long-term immunogenicity and safety of VaxiRab N® (Rabies vaccine) in patients with animal bites
Scientific Title of Study
A prospective, randomized, single-blind, parallel, active-controlled, multicentre, phase IV clinical study to evaluate the long-term immunogenicity and safety of VaxiRab N® compared to a WHO prequalified rabies vaccine in animal bite cases
(1) ICD-10 Condition: W54||Contact with dog, (2) ICD-10 Condition: W53||Contact with rodent,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
A prequalified WHO rabies vaccine
1. Participants enrolled to receive the vaccine via the IM route will receive 5 doses of the allotted vaccine on days 0 (visit 1), 3 (visit 2), 7 (visit 3), 14 (visit 4), and 28 (visit 5). Participants will be administered 1 ml of vaccine in the deltoid region on each vaccination day.
2. Participants enrolled to receive the vaccine via the ID route will receive the vaccine at two sites on days 0 (visit 1), 3 (visit 2), 7 (visit 3), and 28 (visit 5). Participants will be administered with 0.1 ml each of the reconstituted vaccine at two sites having different lymphatic drainage (preferably left and right upper arms) on each vaccination day.
Intervention
VaxiRab N®
1. Participants enrolled to receive the vaccine via the IM route will receive 5 doses of the allotted vaccine on days 0 (visit 1), 3 (visit 2), 7 (visit 3), 14 (visit 4), and 28 (visit 5). Participants will be administered 1 ml of vaccine in the deltoid region on each vaccination day.
2. Participants enrolled to receive the vaccine via the ID route will receive the vaccine at two sites on days 0 (visit 1), 3 (visit 2), 7 (visit 3), and 28 (visit 5). Participants will be administered with 0.1 ml each of the reconstituted vaccine at two sites having different lymphatic drainage (preferably left and right upper arms) on each vaccination day.
3. In the exploratory group 3 (if performed), only 3 doses of VaxiRab N® (Rabies vaccine) (on days 0, 3, and 7) will be administered via the ID route.
For the purpose of this clinical trial, in order to maintain proper accountability of investigational products, one vaccine vial will be used for vaccination of one participant only. Reconstituted vaccine remaining in the vial after intradermal use will not be used for any other participant.
Inclusion Criteria
Age From
3.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
1. 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. Received blood, blood products, or immunoglobulins during the preceding 3 months
8. 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
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Other
Blinding/Masking
Participant Blinded
Primary Outcome
Outcome
TimePoints
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
Outcome
TimePoints
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.
Safety
To evaluate the safety of VaxiRab N® (Rabies vaccine) in comparison to a WHO prequalified rabies vaccine in category II and category III animal bite cases
Exploratory
To evaluate the immunogenicity of 3 doses of VaxiRab N® (Rabies vaccine) administered via intradermal route in category II and category III animal bite cases
Day 3, week 1, week 2, week 13, week 26 and week 52
1. Local and systemic AEs reported during the study
2. Local and systemic AEs reported after each dose of vaccine during the study
3. Serious adverse events (SAEs) reported during the study
Day 3, week 1, week 2, week 13, week 26 and week 52
Target Sample Size
Total Sample Size="476" Sample Size from India="476" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 4
Date of First Enrollment (India)
07/07/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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.