Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-06-30

Brief Summary

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The objective is to assess immunogenicity of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) in terms of Geometric Mean Titers (GMT) for anti-JEV neutralizing antibodies at Day 56 after the first vaccination.

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Detailed Description

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Open-label, multicenter, phase 3 study assessing immunogenicity at various time points throughout the shelf-life of a commercial batch of IC51 (Batch IC51/07F/008) The study population consists of male and female healthy subjects, aged at least 18 years.

The study will be performed at 3 study centers in Germany and Austria. Three sequential cohorts, each containing 100 subjects, will be enrolled into the study at approximately 12, 18 and 24 months after filling of the commercial batch IC51/07F/008 of IC51

Conditions

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Japanese Encephalitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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IC51 (~12 months post filling)

6 mcg (\~12 months post filling)

Group Type ACTIVE_COMPARATOR

IC51

Intervention Type BIOLOGICAL

6 mcg im. at day 0 and day 28

IC51 (~18 months post filling)

6 mcg (\~18 months post filling)

Group Type ACTIVE_COMPARATOR

IC51

Intervention Type BIOLOGICAL

6 mcg im. at day 0 and day 28

IC51 (~24 months post filling)

6 mcg (\~24 months post filling)

Group Type ACTIVE_COMPARATOR

IC51

Intervention Type BIOLOGICAL

6 mcg im. at day 0 and day 28

Interventions

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IC51

6 mcg im. at day 0 and day 28

Intervention Type BIOLOGICAL

Other Intervention Names

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Japanese Encephalitis vaccine

Eligibility Criteria

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Inclusion Criteria

* Male and female healthy adults aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test.

Exclusion Criteria

* History of immunodeficiency or immunosuppressive therapy, known HIV infection, drug addiction including alcohol dependence, prior vaccination against JE

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes