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Rabies Immunization Concomitant With JEV in Children

Primary Purpose

Rabies

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Rabies vaccine
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rabies focused on measuring rabies vaccination, pre-exposure prophylaxis, rabies virus neutralizing antibody, Antibody response, immunologic memory of rabies vaccination, Safety of rabies vaccination administered in pre-exposure regimens both intramuscular and intradermal routes

Eligibility Criteria

12 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male and female 12-18 months old toddlers will be included in the study if they;
  • are in good health at time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator;
  • are available for all the visits scheduled in the study;
  • have been granted a written informed consent signed by their parents

Exclusion Criteria:

  • a history of rabies immunization;
  • a history of Japanese encephalitis immunization or disease;
  • a significant acute or chronic infectious disease at the time of enrollment;
  • fever > 38.0 degree C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment;
  • being under treatment with parenteral, oral and/or inhaled corticosteroids, immunosuppressive drugs or other specific anti-inflammatory drugs or having taken chloroquine during the two months period before enrollment;
  • administration of any vaccine within the past 14 days before enrollment;
  • known immunodeficiency or an autoimmune disease;
  • known hypersensitivity to neomycin, tetracycline, amphotericin-B;
  • planned surgery during the study period;
  • being enrolled in any other investigational trial contemporaneously;
  • the family plans to leave the area of the study site before the end of study period;
  • history of febrile convulsions;
  • history of wheezing

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Placebo Comparator

    Arm Label

    1,2,3,4,5

    Arm Description

    Rabies vaccine 1.0 mL IM on day 0, 7, 28,and 1 year Rabies vaccine 0.5 mL IM on day 0, 7, 28,and 1 year Rabies vaccine 0.1 mL Intradermal on day 0, 7, 28,and 1 year Rabies vaccine 0.1 mL Intradermal on day 0, 28,and 1 year Japanese encephalitis vaccine 0.25 mL subcutaneous

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 20, 2008
    Last Updated
    October 23, 2008
    Sponsor
    Mahidol University
    Collaborators
    Chiron company: Clinical Research and Medical Affairs
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00703521
    Brief Title
    Rabies Immunization Concomitant With JEV in Children
    Official Title
    A Three-Year Clinical Study on Immunogenicity, Safety and Booster Response of Purified Chick Embryo Cell Rabies Vaccine (Pcecv) Administered Intramuscularly or Intradermally to 12- to 18-Month-Old Thai Children Concomitantly With Japanese Encephalitis Vaccine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2002 (undefined)
    Primary Completion Date
    October 2002 (Actual)
    Study Completion Date
    September 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Mahidol University
    Collaborators
    Chiron company: Clinical Research and Medical Affairs

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background. The World Health Organization recommends pre-exposure vaccination (PreP) to protect children living in canine rabies endemic countries. Including PreP in national childhood immunization programs (EPI) is a viable option. Methods. In an open-label phase II clinical trial, 200 healthy toddlers were randomized to receive Purified Chick Embryo Cell Vaccine (PCECV) in a 3-dose Full-IM (1mL), Half-IM (0.5mL), 3-ID (0.1mL), or a 2-dose 2-ID (0.1mL) regimen, all in combination with two doses of Japanese Encephalitis (JEV), or JEV alone. One booster dose of PCECV (IM or ID) and JEV, or JEV alone was administered concomitantly one year after primary vaccination. Safety was evaluated after each injection. Blood was drawn on days 0 and 49, one year later prior to booster and on days 7 and 28 post-booster, and at two and three years post primary vaccination. All sera were analyzed for rabies and JE virus neutralizing antibodies (RVNA, JEVNA).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rabies
    Keywords
    rabies vaccination, pre-exposure prophylaxis, rabies virus neutralizing antibody, Antibody response, immunologic memory of rabies vaccination, Safety of rabies vaccination administered in pre-exposure regimens both intramuscular and intradermal routes

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1,2,3,4,5
    Arm Type
    Placebo Comparator
    Arm Description
    Rabies vaccine 1.0 mL IM on day 0, 7, 28,and 1 year Rabies vaccine 0.5 mL IM on day 0, 7, 28,and 1 year Rabies vaccine 0.1 mL Intradermal on day 0, 7, 28,and 1 year Rabies vaccine 0.1 mL Intradermal on day 0, 28,and 1 year Japanese encephalitis vaccine 0.25 mL subcutaneous
    Intervention Type
    Biological
    Intervention Name(s)
    Rabies vaccine
    Intervention Description
    1.0 mL IM day 0,7,28 and 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Months
    Maximum Age & Unit of Time
    18 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Male and female 12-18 months old toddlers will be included in the study if they; are in good health at time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator; are available for all the visits scheduled in the study; have been granted a written informed consent signed by their parents Exclusion Criteria: a history of rabies immunization; a history of Japanese encephalitis immunization or disease; a significant acute or chronic infectious disease at the time of enrollment; fever > 38.0 degree C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment; being under treatment with parenteral, oral and/or inhaled corticosteroids, immunosuppressive drugs or other specific anti-inflammatory drugs or having taken chloroquine during the two months period before enrollment; administration of any vaccine within the past 14 days before enrollment; known immunodeficiency or an autoimmune disease; known hypersensitivity to neomycin, tetracycline, amphotericin-B; planned surgery during the study period; being enrolled in any other investigational trial contemporaneously; the family plans to leave the area of the study site before the end of study period; history of febrile convulsions; history of wheezing

    12. IPD Sharing Statement

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