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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
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

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

    First Posted
    January 4, 2008
    Last Updated
    March 29, 2016
    Sponsor
    Valneva Austria GmbH
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    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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