Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

NCT ID: NCT00595309

Last Updated: 2014-05-16

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

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-10-31

Brief Summary

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The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in terms of seroconversion rate.

Detailed Description

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Conditions

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Japanese Encephalitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

Group Type ACTIVE_COMPARATOR

IC51

Intervention Type BIOLOGICAL

IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization

Interventions

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IC51

IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy adults who completed the primary immunization in study IC51 309
* Male and female healthy subjects 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 Human Immunodeficiency Virus (HIV), or drug addiction including alcohol dependence
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Valneva Austria GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susanne Eder

Role: STUDY_DIRECTOR

Valneva Austria GmbH

Locations

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Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie

Vienna, , Austria

Site Status

Zentrum für Reisemedizin, Dependance für klinische Studien

Vienna, , Austria

Site Status

Berliner Zentrum Reise- und Tropenmedizin

Berlin, , Germany

Site Status

Countries

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Austria Germany

References

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Eder S, Dubischar-Kastner K, Firbas C, Jelinek T, Jilma B, Kaltenboeck A, Knappik M, Kollaritsch H, Kundi M, Paulke-Korinek M, Schuller E, Klade CS. Long term immunity following a booster dose of the inactivated Japanese Encephalitis vaccine IXIARO(R), IC51. Vaccine. 2011 Mar 21;29(14):2607-12. doi: 10.1016/j.vaccine.2011.01.058. Epub 2011 Feb 1.

Reference Type DERIVED
PMID: 21288804 (View on PubMed)

Other Identifiers

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IC51-311

Identifier Type: -

Identifier Source: org_study_id

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