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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

This study is ongoing, but not recruiting participants.
Study NCT00708084.   Last updated on October 8, 2008.   Information provided by Crucell Holland BV

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Descriptive Information Fields
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 II
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety Study
Primary Outcome Measure  Safety and tolerability [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  Rabies virus neutralizing activity [ Time Frame: 42 days ] [ Designated as safety issue: No ]
Condition  Rabies
Intervention  Biological: CL184
Biological: HRIG
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  48
Start Date  May 2008
Completion Date November 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 to 17 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  Philippines
Administrative Information Fields
NCT ID  NCT00708084
Organization ID RAB-M-A004
Secondary IDs ††
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 Crucell Holland BV
Verification Date October 2008
First Received Date  July 1, 2008
Last Updated Date October 8, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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