Immune Response in IXIARO Batch JEV09L37 Recipients Before and After Revaccination

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-03-31

Brief Summary

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IC51-319 is a single-arm, open-label study that investigates immune responses in subjects undergoing revaccination after receiving the subpotent batch of IXIARO JEV09L37 during primary immunization.

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Detailed Description

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IC51-319 is a single-arm, open-label study that investigates immune responses in subjects undergoing revaccination after receiving the subpotent batch of IXIARO JEV09L37 during primary immunization.

A total of up to 50 subjects having received primary immunization of IXIARO batch JEV09L37 and who have not yet been revaccinated.

Conditions

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Japanese Encephalitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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IXIARO

IXIARO, applied according to licensed dose, intramuscular

Group Type OTHER

IXIARO

Intervention Type BIOLOGICAL

Vero-cell derived Japanese encephalitis (JE) vaccine IXIARO, 0.5 ml intramuscular

Interventions

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IXIARO

Vero-cell derived Japanese encephalitis (JE) vaccine IXIARO, 0.5 ml intramuscular

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subjects 18 years or older having received IXIARO batch JEV09L37 during primary immunization
* In female subjects, either childbearing potential terminated by surgery or 1 year post-menopausal, or a negative urine pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception
* Written informed consent obtained from the subject prior to any study-related procedures

Exclusion Criteria

* Vaccination against Yellow fever, Dengue Fever, West Nile Fever or TBE or vaccination with any JE vaccine since primary immunization with IXIARO JEC09L37
* Clinical manifestation of any flavivirus infection since primary immunization with IXIARO JEC09L37
* Acute febrile infections or exacerbation of chronic infection on the day of IXIARO vaccination
* Pregnancy, lactation or unreliable contraception in female subjects with child-bearing potential and unreliable contraception in male subjects.
* Use of any other investigational or non-registered drug within 30 days prior to the first vaccination with IXIARO Visit 1 and during the study period
* Any condition which might interfere with study objectives or would limit the subject's ability to complete the study in the opinion of the investigator
* Persons who are committed to an institution
* At Day 0, upcoming scheduled travel to a JE endemic region

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes