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Safety and Tolerability of the Japanese Encephalitis Vaccine IC51

Primary Purpose

Japanese Encephalitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Japanese Encephalitis purified inactivated vaccine (IC51)
Placebo
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

Inclusion Criteria:

  • At least 18 years of age
  • Written informed consent obtained prior to study entry

Exclusion Criteria:

  • Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
  • History of any previous JE vaccination (e.g. JE-VAX®)
  • Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
  • A family history of congenital or hereditary immunodeficiency
  • History of autoimmune disease
  • Any acute infections within 2 weeks prior to enrollment
  • Known or suspected HIV Infection
  • Pregnancy, lactation or unreliable contraception in female subjects

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    IC51

    Placebo

    Outcomes

    Primary Outcome Measures

    Safety and Tolerability up to Day 56
    calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)

    Secondary Outcome Measures

    Rates of Serious Adverse Events and Medically Attended Adverse Events
    Changes in Laboratory Parameters
    SCR and GMT of Subjects With Concomitant Vaccinations

    Full Information

    First Posted
    January 4, 2008
    Last Updated
    October 19, 2012
    Sponsor
    Valneva Austria GmbH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00605085
    Brief Title
    Safety and Tolerability of the Japanese Encephalitis Vaccine IC51
    Official Title
    Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Valneva Austria GmbH

    4. Oversight

    5. Study Description

    Brief Summary
    The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged > or = 18 years

    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
    2675 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    IC51
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Biological
    Intervention Name(s)
    Japanese Encephalitis purified inactivated vaccine (IC51)
    Intervention Description
    IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 and 28
    Primary Outcome Measure Information:
    Title
    Safety and Tolerability up to Day 56
    Description
    calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)
    Time Frame
    Day 56
    Secondary Outcome Measure Information:
    Title
    Rates of Serious Adverse Events and Medically Attended Adverse Events
    Time Frame
    until Day 56
    Title
    Changes in Laboratory Parameters
    Time Frame
    until Day 56
    Title
    SCR and GMT of Subjects With Concomitant Vaccinations
    Time Frame
    until Day 56

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: At least 18 years of age Written informed consent obtained prior to study entry Exclusion Criteria: Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine History of any previous JE vaccination (e.g. JE-VAX®) Immunodeficiency including post-organ-transplantation or immunosuppressive therapy A family history of congenital or hereditary immunodeficiency History of autoimmune disease Any acute infections within 2 weeks prior to enrollment Known or suspected HIV Infection Pregnancy, lactation or unreliable contraception in female subjects
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Astrid Kaltenboeck, Ph.D.
    Organizational Affiliation
    Valneva Austria GmbH
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Tolerability of the Japanese Encephalitis Vaccine IC51

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