Safety and Tolerability of the Japanese Encephalitis Vaccine IC51

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2675 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-11-30

Brief Summary

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The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged \> or = 18 years

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Detailed Description

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Conditions

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Japanese Encephalitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

IC51

Group Type EXPERIMENTAL

Japanese Encephalitis purified inactivated vaccine (IC51)

Intervention Type BIOLOGICAL

IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 and 28

Interventions

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Japanese Encephalitis purified inactivated vaccine (IC51)

IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28

Intervention Type BIOLOGICAL

Placebo

Placebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 and 28

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age
* Written informed consent obtained prior to study entry

Exclusion Criteria

* Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
* History of any previous JE vaccination (e.g. JE-VAX®)
* Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
* A family history of congenital or hereditary immunodeficiency
* History of autoimmune disease
* Any acute infections within 2 weeks prior to enrollment
* Known or suspected HIV Infection
* Pregnancy, lactation or unreliable contraception in female subjects

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes