drugset / Trial / NCT01900444

Study of a Booster Dose of IMOJEV® One Year After Primary Immunization in Healthy Children in South Korea

NCT01900444

Phase 3 Completed 119 enrolled Sanofi Pasteur, a Sanofi Company
NaSingle-groupOpen-labelPrevention

Summary

The aim of this study was to document the immunogenicity and safety of a booster dose of IMOJEV administered at least 12 months after the primary dose. Primary objective: * To describe the immune response to Japanese Encephalitis (JE) before and 28 days after a booster dose of IMOJEV administered at least 12 months after primary vaccination with IMOJEV. Exploratory objectives: * To describe the safety profile of a booster dose of IMOJEV® .

Timeline

Start
2013-07-11
Primary completion
2014-03-11
Completion
2014-03-11

Drugs

EvaluationDrugModalityDoseRoute
Subject IMOJEV Vaccine 0.5 ml Subcutaneous

Indications