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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

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

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

NCT ID

NCT00776230

First Posted

October 20, 2008

Last Updated

March 29, 2016

Sponsor

Valneva Austria GmbH

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

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

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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