Status:
COMPLETED
Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in Toddlers
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Rabies
Japanese Encephalitis
Eligibility:
All Genders
12-18 years
Phase:
PHASE2
Brief Summary
This study evaluated the safety and immunogenicity of rabies vaccine and Japanese encephalitis vaccine in toddlers. All children developed adequate immune responses. Rabies vaccination with PCECV did ...
Eligibility Criteria
Inclusion
- Male and female 12-18 months old toddlers if they
- are in good health at time of entry into the study
- 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°C (axillary) or/and significant acute or chronic infection requiring antibiotic or antiviral therapy within the past 7 days before enrollment
- being under treatment with 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
- history of allergy to eggs, egg products
- 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 :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00694460
Start Date
August 1 2002
End Date
September 1 2004
Last Update
June 10 2008
Active Locations (1)
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1
Tropical Medicine, Mahidol University
Bangkok, Thailand, 10400