At a glance
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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
In Brief
A Phase 3 clinical trial evaluating JE-CV Vaccine and Varicella Vaccine for Japanese Encephalitis and Varicella. Completed, enrolled 454 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
0.5 mL (single dose), Subcutaneous
0.5 mL (single dose), Subcutaneous