Rabies Immunization Concomitant With JEV in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00703521
Recruitment Status : Completed
First Posted : June 23, 2008
Last Update Posted : October 24, 2008
Chiron company: Clinical Research and Medical Affairs
Information provided by:
Mahidol University

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).

Condition or disease Intervention/treatment Phase
Rabies Biological: Rabies vaccine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : August 2002
Actual Primary Completion Date : October 2002
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis Rabies

Arm Intervention/treatment
Placebo Comparator: 1,2,3,4,5
  1. Rabies vaccine 1.0 mL IM on day 0, 7, 28,and 1 year
  2. Rabies vaccine 0.5 mL IM on day 0, 7, 28,and 1 year
  3. Rabies vaccine 0.1 mL Intradermal on day 0, 7, 28,and 1 year
  4. Rabies vaccine 0.1 mL Intradermal on day 0, 28,and 1 year
  5. Japanese encephalitis vaccine 0.25 mL subcutaneous
Biological: Rabies vaccine
1.0 mL IM day 0,7,28 and 1 year

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Ages Eligible for Study:   12 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Responsible Party: Prof. Arunee Sabchareon, Department of Tropical Pediatrics Identifier: NCT00703521     History of Changes
Other Study ID Numbers: M49P2
First Posted: June 23, 2008    Key Record Dates
Last Update Posted: October 24, 2008
Last Verified: June 2008

Keywords provided by Mahidol University:
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

Additional relevant MeSH terms:
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Immunologic Factors
Physiological Effects of Drugs