Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51

Valneva Austria GmbH3,258 enrolled

Overview

The study investigates the long term safety and immunogenicity of the Japanese Encephalitis vaccine IC51 up to month 60.

Study Type

OBSERVATIONAL

Enrollment

3,258

Conditions

Japanese Encephalitis

Interventions

Japanese Encephalitis purified inactivated vaccineBIOLOGICAL

Japanese Encephalitis purified inactivated vaccine

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subjects at least 18 years of age * Written informed consent obtained prior to study entry * Subjects correctly included and having completed clinical studies IC51-301 (NCT00604708) and IC51-302 (NCT00605085) with at least one vaccination Exclusion Criteria: * Inability or unwillingness to provide informed consent and to abide the requirements of the study

Outcomes

Primary Outcomes

Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)

first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302

Time frame: 24 months after the first vaccination

Secondary Outcomes

Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)

Time frame: 6, 12, 36, 48 and 60 months after 1st vaccination

Geometric Mean Titers

Time frame: 6, 12, 36, 48 and 60 months

Adverse Events

Time frame: 6, 12, 24, 36, 48 and 60 months after 1st vaccination

Data from ClinicalTrials.gov

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