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
About this trial
This is an interventional prevention trial for Japanese Encephalitis
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
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
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
We'll reach out to this number within 24 hrs