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Clinical Trial 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® .


Clinical Trial Description

Participants who previously participated in Study JEC12 (NCT01396512) and were primed with IMOJEV received a booster dose of IMOJEV at least 12 months after the primary dose. Participants were assessed for immune response before and on Day 28 after the booster dose and were monitored for safety through Day 28 post-vaccination for non-serious adverse events (AEs) and up to 6 months post-vaccination for serious AEs The duration of each participant's participation in the study was approximately 6 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01900444
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date July 11, 2013
Completion date March 11, 2014

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