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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 has been completed.
Study NCT00708084   Information provided by Crucell Holland BV
First Received: July 1, 2008   Last Updated: July 31, 2009   History of Changes

July 1, 2008
July 31, 2009
May 2008
October 2008   (final data collection date for primary outcome measure)
Safety and tolerability [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00708084 on ClinicalTrials.gov Archive Site
Rabies virus neutralizing activity [ Time Frame: 42 days ] [ Designated as safety issue: No ]
Same as current
 
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
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

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.

 
Phase II
Interventional
Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety Study
Rabies
  • Biological: CL184
  • Biological: HRIG
  • Experimental: CL184 combined with rabies vaccination
  • Active Comparator: HRIG combined with rabies vaccination
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
48
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
5 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT00708084
Christophe Python/Clinical Development Manager, Crucell, Berna Biotech Ltd.
RAB-M-A004
Crucell Holland BV
 
Principal Investigator: Beatriz P. Quiambao, MD Research Institute for Tropical Medicine, Alabang, Muntinlupa, Metro Manila, Philippines
Crucell Holland BV
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP