Back to resultsComparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51
Primary Purpose
Japanese Encephalitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Japanese Encephalitis purified inactivated vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Japanese Encephalitis
Eligibility Criteria
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
Sites / Locations
- Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
- Berliner Zentrum Reise- und Tropenmedizin
- Klinikum der Universität München, Abteilung für Infektions- und Tropenmedizin
- Klinik und Poliklinik für Innere Medizin der Universität Rostock
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
IC51 Batch A
IC51 Batch B
IC51 Batch C
Arm Description
Outcomes
Primary Outcome Measures
Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody
Secondary Outcome Measures
Seroconversion Rate
Safety and Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00595465
Brief Title
Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51
Official Title
Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
June 2008 (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 demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody
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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
389 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IC51 Batch A
Arm Type
Active Comparator
Arm Title
IC51 Batch B
Arm Type
Active Comparator
Arm Title
IC51 Batch C
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Japanese Encephalitis purified inactivated vaccine
Intervention Description
IC51 6 mcg i.m. injection on Day 0 and Day 28
Primary Outcome Measure Information:
Title
Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody
Time Frame
Day 56
Secondary Outcome Measure Information:
Title
Seroconversion Rate
Time Frame
Day 56
Title
Safety and Adverse Events
Time Frame
Day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Haas
Organizational Affiliation
Valneva Austria GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
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
Klinikum der Universität München, Abteilung für Infektions- und Tropenmedizin
City
Munich
ZIP/Postal Code
80802
Country
Germany
Facility Name
Klinik und Poliklinik für Innere Medizin der Universität Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51
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