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Rabies Immunization Concomitant With JEV in Children

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Disease Information

Descriptive Information
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
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).
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Rabies
Intervention † BiologicalRabies vaccine
Study Arms / Comparison Groups 1,2,3,4,5 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
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Biological
Estimated Enrollment † 200
Start Date † August 2002
Completion Date September 2005
Primary Completion Date October 2002
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
Gender Both
Ages 12 Months - 18 Months
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries †
Administrative Information
NCT ID † NCT00703521
Organization ID M49P2
Secondary IDs ††
Responsible Party
Study Sponsor † Mahidol University
Collaborators †† Chiron company: Clinical Research and Medical Affairs
Investigators † : ,
Information Provided By
Verification Date June 2008
First Received Date † June 20, 2008
Last Updated Date October 23, 2008
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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