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

Primary Purpose

Japanese Encephalitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IC51
Sponsored by
Valneva Austria GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Japanese Encephalitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Zentrum für Reisemedizin
  • Berliner Zentrum Reise- und Tropenmedizin
  • Universitätsklinikum Rostock

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

IC51 (~12 months post filling)

IC51 (~18 months post filling)

IC51 (~24 months post filling)

Arm Description

6 mcg (~12 months post filling)

6 mcg (~18 months post filling)

6 mcg (~24 months post filling)

Outcomes

Primary Outcome Measures

Primary: 1. Geometric Mean Titers (GMT) at Day 56

Secondary Outcome Measures

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

Full Information

First Posted
October 20, 2008
Last Updated
March 29, 2016
Sponsor
Valneva Austria GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00776230
Brief Title
Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valneva Austria GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Japanese Encephalitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IC51 (~12 months post filling)
Arm Type
Active Comparator
Arm Description
6 mcg (~12 months post filling)
Arm Title
IC51 (~18 months post filling)
Arm Type
Active Comparator
Arm Description
6 mcg (~18 months post filling)
Arm Title
IC51 (~24 months post filling)
Arm Type
Active Comparator
Arm Description
6 mcg (~24 months post filling)
Intervention Type
Biological
Intervention Name(s)
IC51
Other Intervention Name(s)
Japanese Encephalitis vaccine
Intervention Description
6 mcg im. at day 0 and day 28
Primary Outcome Measure Information:
Title
Primary: 1. Geometric Mean Titers (GMT) at Day 56
Time Frame
56 days post 1st vaccination
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelyn Hatzenbichler
Organizational Affiliation
Valneva Austria GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Zentrum für Reisemedizin
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Berliner Zentrum Reise- und Tropenmedizin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitätsklinikum Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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