drugset / Trial / NCT04062669

A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Experimental Rabies Vaccine in Healthy Adults

NCT04062669

Phase 1 Completed 160 enrolled GlaxoSmithKline
RandomizedSequentialQuadruple-blindPrevention

Summary

The purpose of this first time-in-human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of different dose levels of an experimental rabies glycoprotein G (RG) vaccine (RG-SAM \[CNE\] vaccine), made using a new technology, when administered intramuscularly (IM) on a 0, 2, 6 \*-month schedule to healthy adults. \* There will be no vaccinations with the third dose of any of the study treatments.

Timeline

Start
2019-08-13
Primary completion
2021-07-28
Completion
2022-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK3903133A Vaccine Intramuscular
Comparator Rabies vaccine Vaccine Intramuscular