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Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51

NCT ID: NCT00596102

Last Updated: 2014-07-30

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

Total Enrollment

3258 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Japanese Encephalitis

Study Design

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Observational Model Type

COHORT

Interventions

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Japanese Encephalitis purified inactivated vaccine

Japanese Encephalitis purified inactivated vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
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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Evelyn Hatzenbichler, Ph.D.

Role: STUDY_DIRECTOR

Valneva Austria GmbH

References

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Taucher C, Kollaritsch H, Dubischar KL. Persistence of the immune response after vaccination with the Japanese encephalitis vaccine, IXIARO(R) in healthy adults: A five year follow-up study. Vaccine. 2019 May 1;37(19):2529-2531. doi: 10.1016/j.vaccine.2019.03.030. Epub 2019 Apr 5.

Reference Type DERIVED
PMID: 30962094 (View on PubMed)

Other Identifiers

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IC51-303

Identifier Type: -

Identifier Source: org_study_id

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