Status:
COMPLETED
Randomized Phase II Trial on Safety and Neutralizing Activity of CL184 and Rabies Vaccine Versus Human Rabies Immune Globulin (HRIG) and Rabies Vaccine in Children and Adolescents
Lead Sponsor:
Crucell Holland BV
Conditions:
Rabies
Eligibility:
All Genders
5-17 years
Phase:
PHASE2
Brief Summary
The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in combination with rabies vaccine compared with human rabies immune globulin (HRIG) in combination with rabie...
Eligibility Criteria
Inclusion
- Subjects free of obvious health-problems or with stable conditions
- Male or female subject aged ≥5 to ≤18 years
- Subject is living, studying, or working close to the study referral site
- Parent or legal representative signed written informed consent; in addition for subjects ≥12 years: signed assent form
Exclusion
- Prior history of rabies exposure or immunization (rabies vaccine and/or immune globulin)
- Acute infection or disease within the last 2 weeks
- History and/or family history of clinically significant immunodeficiency or auto-immune disease
- Any history of known or suspected anaphylaxis or hypersensitivity reaction
- Planned immunization with live vaccines during the next 3 months
- Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00708084
Start Date
May 1 2008
End Date
October 1 2008
Last Update
March 20 2012
Active Locations (1)
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1
Research Institute for Tropical Medicine
Alabang, Muntinlupa, Metro Manila, Philippines