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Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440

Primary Purpose

Japanese Encephalitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
IC51
HAVRIX
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
  • In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the study period and 30 days after the last vaccination by practicing reliable methods of contraception
  • Written informed consent obtained prior to study entry

Exclusion Criteria:

  • History of clinical manifestation of any flavivirus infection
  • History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer >= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
  • History of any previous Hepatitis A vaccination and infection
  • 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
  • Planned administration of another vaccine during the study period
  • Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
  • A family history of congenital or hereditary immunodeficiency
  • History of autoimmune disease
  • Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
  • Any acute infections within 4 weeks prior to enrollment
  • Infection with human immunodeficiency virus (HIV), Hepatitis B (HBsAg) or Hepatitis C

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    IC51 and Placebo

    HAVRIX and placebo

    IC51 and HAVRIX

    Arm Description

    6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)

    HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)

    IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)

    Outcomes

    Primary Outcome Measures

    Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies
    anti-JEV Neutralizing Antibodies were tabulated for IC51 groups only; for HAV GMTs (co-primary endpoint GMT for Hepatitis A Virus (HAV) Antibody at Day 28), please refer to "Outcome 2" within outcome measure section
    GMT for Hepatitis A Virus (HAV) Antibody at Day 28

    Secondary Outcome Measures

    Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28
    GMT and SCR for PRNT at Day 28 and HAV at Day 56
    Safety
    Rate of Adverse Events (AEs), Serious Adverse Events (SAEs) and medically attended AEs, local and systemic tolerability, changes in safety laboratory parameters (hematology, serum chemistry, urinalysis)

    Full Information

    First Posted
    January 4, 2008
    Last Updated
    April 9, 2014
    Sponsor
    Valneva Austria GmbH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00596271
    Brief Title
    Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440
    Official Title
    Safety and Immunogenicity of Concomitant Vaccination With IC51 and HARVIX® 1440 in Healthy Subjects. A Single-blind Randomized, Controlled Phase 3 Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    July 2006 (Actual)
    Study Completion Date
    August 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 investigate the immunogenicity of the Japanese Encephalitis vaccine IC51 (JE-PIV) single and concomitant with HAVRIX® 1440
    Detailed Description
    This is a randomized, controlled, multi-center, single-blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years. 192 subjects will be enrolled at 2 sites in Europe.

    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
    Participant
    Allocation
    Randomized
    Enrollment
    192 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IC51 and Placebo
    Arm Type
    Active Comparator
    Arm Description
    6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
    Arm Title
    HAVRIX and placebo
    Arm Type
    Active Comparator
    Arm Description
    HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
    Arm Title
    IC51 and HAVRIX
    Arm Type
    Active Comparator
    Arm Description
    IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
    Intervention Type
    Biological
    Intervention Name(s)
    IC51
    Other Intervention Name(s)
    Japanese Encephalitis purified inactivated vaccine
    Intervention Type
    Biological
    Intervention Name(s)
    HAVRIX
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies
    Description
    anti-JEV Neutralizing Antibodies were tabulated for IC51 groups only; for HAV GMTs (co-primary endpoint GMT for Hepatitis A Virus (HAV) Antibody at Day 28), please refer to "Outcome 2" within outcome measure section
    Time Frame
    Day 56
    Title
    GMT for Hepatitis A Virus (HAV) Antibody at Day 28
    Time Frame
    Day 28
    Secondary Outcome Measure Information:
    Title
    Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28
    Time Frame
    day 28 and 56
    Title
    GMT and SCR for PRNT at Day 28 and HAV at Day 56
    Time Frame
    day 28 and 56
    Title
    Safety
    Description
    Rate of Adverse Events (AEs), Serious Adverse Events (SAEs) and medically attended AEs, local and systemic tolerability, changes in safety laboratory parameters (hematology, serum chemistry, urinalysis)
    Time Frame
    until 6 month after last vaccination

    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 In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the study period and 30 days after the last vaccination by practicing reliable methods of contraception Written informed consent obtained prior to study entry Exclusion Criteria: History of clinical manifestation of any flavivirus infection History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer >= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis) History of any previous Hepatitis A vaccination and infection 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 Planned administration of another vaccine during the study period Immunodeficiency including post-organ-transplantation or immunosuppressive therapy A family history of congenital or hereditary immunodeficiency History of autoimmune disease Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. Any acute infections within 4 weeks prior to enrollment Infection with human immunodeficiency virus (HIV), Hepatitis B (HBsAg) or Hepatitis C
    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

    Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440

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