Status:
COMPLETED
Rabies Immunization Concomitant With JEV in Children
Lead Sponsor:
Mahidol University
Collaborating Sponsors:
Chiron company: Clinical Research and Medical Affairs
Conditions:
Rabies
Eligibility:
All Genders
12-18 years
Phase:
PHASE2
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 pr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2005
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00703521
Start Date
August 1 2002
End Date
September 1 2005
Last Update
October 24 2008
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