Immune Response in IXIARO Batch JEV09L37 Recipients Before and After Revaccination

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by (Responsible Party):

Intercell AG

ClinicalTrials.gov Identifier:

NCT01559831

First received: March 19, 2012

Last updated: March 7, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 19, 2012

Last Updated Date

March 7, 2013

Start Date ^ICMJE

June 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Seroconversion rate (SCR) at Day 28 [ Time Frame: at Day 28 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01559831 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

SCR at Day 0 [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
Geometric Mean Titer at Day 0 and 28 [ Time Frame: Day 0 and Day 28 ] [ Designated as safety issue: No ]
Rate of Adverse Events up to Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Immune Response in IXIARO Batch JEV09L37 Recipients Before and After Revaccination

Official Title ^ICMJE

Immune Responses to Revaccination After Potentially Insufficient Priming With the Japanese Encephalitis Vaccine IXIARO Batch JEV09L37

Brief Summary

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.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Japanese Encephalitis

Intervention ^ICMJE

Biological: IXIARO

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

Study Arm (s)

IXIARO

IXIARO, applied according to licensed dose, intramuscular

Intervention: Biological: IXIARO

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Estimated Completion Date

March 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01559831

Other Study ID Numbers ^ICMJE

IC51-319

Has Data Monitoring Committee

Responsible Party

Intercell AG

Study Sponsor ^ICMJE

Intercell AG

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Vera Kadlecek, Mag.

Intercell AG

Information Provided By

Intercell AG

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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