Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

May 5, 2014 updated by: Valneva Austria GmbH

Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51 on Long Term Immunogenicity. An Uncontrolled, Open-label Phase 3 Study.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Phase 3

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

  • Austria
      • Vienna, Austria
        • Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
      • Vienna, Austria
        • Zentrum für Reisemedizin, Dependance für klinische Studien
  • Germany
      • Berlin, Germany
        • Berliner Zentrum Reise- und Tropenmedizin

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

No

Genders Eligible for Study

All

Description

Main 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

Main Exclusion Criteria:

• History of immunodeficiency or immunosuppressive therapy, known Human Immunodeficiency Virus (HIV), or drug addiction including alcohol dependence

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Biological: IC51
IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Seroconversion Rate
Time Frame: at Month 12 after booster
at Month 12 after booster

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and Adverse Events
Time Frame: up to Month 12 after booster
up to Month 12 after booster
Seroconversion
Time Frame: at D28 and Month 6 after booster
at D28 and Month 6 after booster
Geometric Mean Titer
Time Frame: D28, Month 6 and Month 12 after booster
D28, Month 6 and Month 12 after booster

Collaborators and Investigators

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

Sponsor

Valneva Austria GmbH

Investigators

  • Study Director: Susanne Eder, Valneva Austria GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

January 4, 2008

First Submitted That Met QC Criteria

January 4, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Estimate)

May 16, 2014

Last Update Submitted That Met QC Criteria

May 5, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC51-311

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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