drugset / Trial / NCT01137045

Immunogenicity and Safety Study of A New Chromatographically Purified Vero Cell Rabies Vaccine With ID Regimen and ERIG

NCT01137045 ↗

Phase 4 Completed 210 enrolled Queen Saovabha Memorial Institute
RandomizedFactorialSingle-blindTreatment

Summary

A comparative,randomized (1:1)study to evaluate the safety and immunogenicity of a new chromatographically purified vero cell rabies vaccine (SPEEDA) and chromatographically purified vero cell rabies vaccine (SPEEDA)which is filled by Queen Saovabha Memorial Institute (TRCS SPEEDA)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.

Timeline

Start
2010-06
Primary completion
2018-04
Completion
2018-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator SPEEDA Vaccine 0.1 ml Other
Comparator TRCS SPEEDA Unknown 0.1 ml Other

Indications