NCT01900444

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

Immunogenicity and Safety Exploration of a Booster Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Given One Year After Primary Immunization in Healthy Children in South Korea

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Years – 4 Years
• Healthy volunteers: Accepted

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® .

Detailed 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.

Conditions

• Japanese Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	IMOJEV	0.5 mL, Subcutaneous

Timeline

• Start date: 2013-07-11
• Primary completion: 2014-03-11
• Completion: 2014-03-11
• First posted: 2013-07-16
• Last updated: 2022-03-28
• Results posted: 2017-12-13

Locations

8 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study