Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51

May 5, 2014 updated by: Valneva Austria GmbH

Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.

The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

389

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, 1090
        • Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
  • Germany
      • Berlin, Germany, 10117
        • Berliner Zentrum Reise- und Tropenmedizin
      • Munich, Germany, 80802
        • Klinikum der Universität München, Abteilung für Infektions- und Tropenmedizin
      • Rostock, Germany, 18057
        • Klinik und Poliklinik für Innere Medizin der Universität Rostock

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

Main Inclusion Criteria:

  • Male and female healthy adults 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IC51 Batch A
Biological: Japanese Encephalitis purified inactivated vaccine
IC51 6 mcg i.m. injection on Day 0 and Day 28
Active Comparator: IC51 Batch B
Biological: Japanese Encephalitis purified inactivated vaccine
IC51 6 mcg i.m. injection on Day 0 and Day 28
Active Comparator: IC51 Batch C
Biological: Japanese Encephalitis purified inactivated vaccine
IC51 6 mcg i.m. injection on Day 0 and Day 28

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody
Time Frame: Day 56
Day 56

Secondary Outcome Measures

Outcome Measure
Time Frame
Seroconversion Rate
Time Frame: Day 56
Day 56
Safety and Adverse Events
Time Frame: Day 56
Day 56

Collaborators and Investigators

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

Sponsor

Valneva Austria GmbH

Investigators

  • Study Director: Nicole Haas, 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

December 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

January 4, 2008

First Submitted That Met QC Criteria

January 15, 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

  • IC51-310

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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