Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51
Primary Purpose
Japanese Encephalitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
IC51
Sponsored by
About this trial
This is an interventional prevention trial for Japanese Encephalitis
Eligibility Criteria
Main Inclusion Criteria:
- Male and female subjects 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 HIV, drug addiction including alcohol dependence
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
IC51 Group A
IC51 Group B
IC51 Group C
Arm Description
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
Outcomes
Primary Outcome Measures
GMT for Anti-JEV Neutralizing Antibody
Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2.
Secondary Outcome Measures
Safety
Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability
SCR for Anti-JEC Neutralizing Antibody Titer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00594958
Brief Title
Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51
Official Title
Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
September 2007 (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 IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.
Detailed Description
This is a randomized, controlled, multi-center, double blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years.
624 subjects will be enrolled at approximately 6 sites in study centers in Austria and Germany.
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
639 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IC51 Group A
Arm Type
Active Comparator
Arm Description
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
Arm Title
IC51 Group B
Arm Type
Active Comparator
Arm Description
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
Arm Title
IC51 Group C
Arm Type
Active Comparator
Arm Description
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
Intervention Type
Biological
Intervention Name(s)
IC51
Other Intervention Name(s)
Japanese Encephalitis purified inactivated vaccine
Intervention Description
6 mcg, intramuscularly [i.m.], 0.5 mL
Primary Outcome Measure Information:
Title
GMT for Anti-JEV Neutralizing Antibody
Description
Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2.
Time Frame
day 56
Secondary Outcome Measure Information:
Title
Safety
Description
Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability
Time Frame
study duration
Title
SCR for Anti-JEC Neutralizing Antibody Titer
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 subjects 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 HIV, drug addiction including alcohol dependence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Eder, Mag.
Organizational Affiliation
Valneva Austria GmbH
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51
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