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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 currently recruiting participants.
Verified by Crucell Holland BV, July 2008

Sponsored by: Crucell Holland BV
Information provided by: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT00708084
  Purpose

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.


Condition Intervention Phase
Rabies
Biological: CL184
Biological: HRIG
Phase II

MedlinePlus related topics:   Rabies   

ChemIDplus related topics:   Globulin, Immune    Immunoglobulins    Rabies Vaccine    Rabies Vaccines   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety Study
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

Further study details as provided by Crucell Holland BV:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rabies virus neutralizing activity [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Estimated Enrollment:   48
Study Start Date:   May 2008
Estimated Study Completion Date:   November 2008
Estimated Primary Completion Date:   November 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
CL184 combined with rabies vaccination
Biological: CL184
CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
B: Active Comparator
HRIG combined with rabies vaccination
Biological: HRIG
HRIG 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28

  Eligibility
Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708084

Contacts
Contact: Beatriz P. Quiambao, MD     bpquiambao@yahoo.com    

Locations
Philippines
Research Institute for Tropical Medicine     Recruiting
      Alabang, Muntinlupa, Metro Manila, Philippines
      Contact: Beatriz P. Quiambao, MD         bpquiambao@yahoo.com    
      Principal Investigator: Beatriz P. Quiambao, MD            

Sponsors and Collaborators
Crucell Holland BV

Investigators
Principal Investigator:     Beatriz P. Quiambao, MD     Research Institute for Tropical Medicine, Alabang, Muntinlupa, Metro Manila, Philippines    
  More Information

Responsible Party:   Crucell, Berna Biotech Ltd. ( Christophe Python/Clinical Development Manager )
Study ID Numbers:   RAB-M-A004
First Received:   July 1, 2008
Last Updated:   July 1, 2008
ClinicalTrials.gov Identifier:   NCT00708084
Health Authority:   United States: Food and Drug Administration;   Philippines: Department of Health

Keywords provided by Crucell Holland BV:
Rabies post-exposure prophylaxis  
Monoclonal antibody  

Study placed in the following topic categories:
Antibodies, Monoclonal
Virus Diseases
Antibodies
Rabies
Immunoglobulins

Additional relevant MeSH terms:
RNA Virus Infections
Immunologic Factors
Physiological Effects of Drugs
Rhabdoviridae Infections
Pharmacologic Actions
Mononegavirales Infections

ClinicalTrials.gov processed this record on September 05, 2008




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