drugset / Trial / NCT01190228

Study of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With JE-CV

NCT01190228

Phase 3 Completed 454 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupOpen-labelPrevention

Summary

The aim of the study is to investigate the memory immune response and the yearly persistence of the immunity against Japanese Encephalitis (JE) after vaccination with Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in participants previously vaccinated with JE-CV vaccine. Objectives: * To describe JE immune status before and after JE-CV vaccination in subjects previously vaccinated with JE-CV vaccine * To describe the immune status before and after JE-CV vaccination in JE-naïve control subjects. * To describe the safety (in terms of solicited and unsolicited adverse events) of a single dose of JE-CV vaccine up to 6 months after the last vaccination. * To describe all related serious adverse events (SAEs) and related deaths from 6 months to 5 years after vaccination in JE-CV-primed subjects.

Timeline

Start
2010-08-25
Primary completion
2010-10-29
Completion
2015-10-12

Drugs

EvaluationDrugModalityDoseRoute
Subject IMOJEV Vaccine 0.5 ml Subcutaneous
Comparator Varicella vaccine Vaccine 0.5 ml Subcutaneous