Health Condition 1: W54- Contact with dog Health Condition 2: W53- Contact with rodent
Conditions
Interventions
Intervention1: 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), a
Sponsors
Zydus Lifesciences Limited
Cliantha Research limited
Eligibility
Inclusion criteria
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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 vaccineTimepoint: Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Timepoint: 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 | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed