Immune Response in IXIARO Batch JEV09L37 Recipients Before and After Revaccination

March 7, 2013 updated by: Valneva Austria GmbH

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1E 6JB
        • UCLH Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: IXIARO
IXIARO, applied according to licensed dose, intramuscular
Biological: IXIARO
Vero-cell derived Japanese encephalitis (JE) vaccine IXIARO, 0.5 ml intramuscular

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Seroconversion rate (SCR) at Day 28
Time Frame: at Day 28
at Day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
SCR at Day 0
Time Frame: Day 0
Day 0
Geometric Mean Titer at Day 0 and 28
Time Frame: Day 0 and Day 28
Day 0 and Day 28
Rate of Adverse Events up to Day 28
Time Frame: Day 28
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valneva Austria GmbH

Investigators

  • Study Chair: Vera Kadlecek, Mag., Valneva Austria GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

March 19, 2012

First Submitted That Met QC Criteria

March 20, 2012

First Posted (Estimate)

March 21, 2012

Study Record Updates

Last Update Posted (Estimate)

March 8, 2013

Last Update Submitted That Met QC Criteria

March 7, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC51-319

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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