NCT01190228

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

Assessment of the Memory Immune Response, Safety of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With a Single Dose of JE-CV and Long-Term Follow-Up

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 454 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 36 Months – 42 Months
• Healthy volunteers: Accepted

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.

Detailed description

Study participants who are previously immunized with JE-CV vaccine will receive a booster dose of the JE-CV vaccine and will be followed up for 5 years for immunogenicity. The control (JE-CV naïve) participants will receive either one dose of JE-CV vaccine or one dose of varicella vaccine. All participants will be monitored for safety for 6 month post-vaccination.

Conditions

• Japanese Encephalitis
• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	JE-CV Vaccine	0.5 mL (single dose), Subcutaneous
BIOLOGICAL	Varicella Vaccine	0.5 mL (single dose), Subcutaneous

Timeline

• Start date: 2010-08-25
• Primary completion: 2010-10-29
• Completion: 2015-10-12
• First posted: 2010-08-27
• Last updated: 2022-03-28
• Results posted: 2017-11-08

Locations

1 site across 1 country: Philippines

Regulatory

• FDA-regulated drug study