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drugset / Trial / NCT06066294

A Comparison of Safety and Immunogenicity of Rabies Pre Exposure Prophylaxis Regimen Between Gvt of India Approved and WHO Approved.

NCT06066294 ↗

Phase 3 Unknown 115 enrolled Kempegowda Institute of Medical Sciences, Bangalore
RandomizedParallel-groupOpen-labelPrevention

Summary

The goal of this clinical trial is to compare WHO recommended PrEP Vaccination Schedule, 2 doses 0.2ml 2 sites (0.1ml each site) on day 0 and day 7 and Government of India currently recommended PrEP Schedule, 0.1ml 3 doses on day 0, day 7 and day 28 in Healthy subjects above 18years of age, willing to volunteer and sign written informed consent for the study. The main questions it aims to answer are: * To assess the seroconversion (? 0.5 IU/mL) of the study subjects following primary \& boosting vaccination on Day 35 ,Day 365, Day 372/375. * To assess the incidence of adverse events(immediate/delayed, local/systemic) among subjects. Participants will be administerd with WHO Pre-qualified rabies vaccine (Rabivax-S) . Researchers will compare the two regimens mentioned above.

Timeline

Start
2023-04-03
Primary completion
2023-11
Completion
2024-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Rabivax-S Vaccine 0.1 ml Intravenous
Subject Rabivax-S Vaccine 0.2 ml Intravenous

Indications

No indication recorded.