Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling

March 29, 2016 updated by: Valneva Austria GmbH

Immunogenicity of a Commercial Batch of the Japanese Encephalitis Vaccine IC51 up to Twenty-four Months Post Filling. An Open-label, Multicenter, Phase 3 Study

The objective is to assess immunogenicity of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) in terms of Geometric Mean Titers (GMT) for anti-JEV neutralizing antibodies at Day 56 after the first vaccination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Open-label, multicenter, phase 3 study assessing immunogenicity at various time points throughout the shelf-life of a commercial batch of IC51 (Batch IC51/07F/008) The study population consists of male and female healthy subjects, aged at least 18 years.

The study will be performed at 3 study centers in Germany and Austria. Three sequential cohorts, each containing 100 subjects, will be enrolled into the study at approximately 12, 18 and 24 months after filling of the commercial batch IC51/07F/008 of IC51

Study Type

Interventional

Enrollment (Actual)

304

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
        • Zentrum für Reisemedizin
  • Germany
      • Berlin, Germany, 10117
        • Berliner Zentrum Reise- und Tropenmedizin
      • Rostock, Germany, 18057
        • Universitätsklinikum 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

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.

Exclusion Criteria:

  • History of immunodeficiency or immunosuppressive therapy, known HIV infection, drug addiction including alcohol dependence, prior vaccination against JE

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IC51 (~12 months post filling)
6 mcg (~12 months post filling)
Biological: IC51
6 mcg im. at day 0 and day 28
Other Names:
  • Japanese Encephalitis vaccine
Active Comparator: IC51 (~18 months post filling)
6 mcg (~18 months post filling)
Biological: IC51
6 mcg im. at day 0 and day 28
Other Names:
  • Japanese Encephalitis vaccine
Active Comparator: IC51 (~24 months post filling)
6 mcg (~24 months post filling)
Biological: IC51
6 mcg im. at day 0 and day 28
Other Names:
  • Japanese Encephalitis vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary: 1. Geometric Mean Titers (GMT) at Day 56
Time Frame: 56 days post 1st vaccination
56 days post 1st vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary: 1. Seroconversion Rate 2. GMTs Day 28, Month 6 and Month 12 3. Treatment Emergent Adverse Events 4. Systemic and Local Tolerability
Time Frame: see above
see above

Collaborators and Investigators

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

Sponsor

Valneva Austria GmbH

Investigators

  • Study Director: Evelyn Hatzenbichler, 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

September 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

October 20, 2008

First Submitted That Met QC Criteria

October 20, 2008

First Posted (Estimate)

October 21, 2008

Study Record Updates

Last Update Posted (Estimate)

May 4, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC51-314

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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