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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

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Disease Information

Descriptive Information
Brief Title † 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
Official Title † A Single-blind, Randomized, Monocentric Phase II Trial to Explore the Safety and Rabies-neutralizing Activity of Combined Administration of CL184 and Rabies Vaccine Versus Human Rabies Immune Globulin Plus Rabies Vaccine in Simulated Rabies Post-exposure Prophylaxis in Children and Adolescents
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 rabies vaccine in healthy children and adolescents.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary Outcome Measure † Safety and tolerability
Secondary Outcome Measure † Rabies virus neutralizing activity
Condition † Rabies
Intervention † BiologicalCL184
Study Arms / Comparison Groups A CL184 combined with rabies vaccination B HRIG combined with rabies vaccination
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 † 48
Start Date † May 2008
Completion Date October 2008
Primary Completion Date October 2008
Eligibility Criteria † Inclusion Criteria: - 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 Criteria: - 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
Gender Both
Ages 5 Years - 17 Years
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries † Philippines
Administrative Information
NCT ID † NCT00708084
Organization ID RAB-M-A004
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Crucell Holland BV
Collaborators ††
Investigators † Principal Investigator: Beatriz P. Quiambao, MD, Research Institute for Tropical Medicine, Alabang, Muntinlupa, Metro Manila, Philippines
Information Provided By
Verification Date March 2012
First Received Date † July 1, 2008
Last Updated Date March 19, 2012
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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