NCT01001988

Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Toddlers

Long-term Follow-up of Immunogenicity of a Single Dose of JE-CV in Toddlers in Thailand and the Philippines

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 596 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Years – 3 Years
• Healthy volunteers: Accepted

Summary

This is a long-term follow-up of the persistence of immune response in participants who previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02 (NCT00735644) . No vaccination was administered during the present long-term follow-up study. Primary Objective: * To describe the yearly persistence of humoral immune response to Japanese encephalitis after a single dose of JE-CV

Detailed description

Persistence of immune response will be determined in participants who previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02 (NCT00735644). No vaccination will be given in this study.

Conditions

• Encephalitis
• Japanese Encephalitis

Interventions

Type	Name	Description
OTHER	Blood sample	Blood sample for immunogenicity assessment
BIOLOGICAL	JE-CV administered in Study JEC02	Participants received a single dose of JE-CV at 12 to 18 months of age in Study JEC02. No vaccination was administered in Study JEC05

Timeline

• Start date: 2009-08-07
• Primary completion: 2013-10-16
• Completion: 2013-10-16
• First posted: 2009-10-27
• Last updated: 2017-11-29
• Results posted: 2017-11-29

Locations

4 sites across 2 countries: Philippines, Thailand

Regulatory

• FDA-regulated drug study