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.

First Received: July 1, 2008 Last Updated: July 31, 2009 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Rabies

Drug Information available for: Immunoglobulins Rabies Vaccine Rabies Vaccines Globulin, Immune

U.S. FDA Resources

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
Study Completion Date:	October 2008
Primary Completion Date:	October 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

Locations

Philippines
Research Institute for Tropical Medicine
Alabang, Muntinlupa, Metro Manila, Philippines

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

No publications provided

Responsible Party:	Crucell, Berna Biotech Ltd. ( Christophe Python/Clinical Development Manager )
Study ID Numbers:	RAB-M-A004
Study First Received:	July 1, 2008
Last Updated:	July 31, 2009
ClinicalTrials.gov Identifier:	NCT00708084 History of Changes
Health Authority:	United States: Food and Drug Administration; Philippines: Department of Health

Keywords provided by Crucell Holland BV:

Rabies post-exposure prophylaxis
Monoclonal antibody

Additional relevant MeSH terms:

Virus Diseases
Antibodies
RNA Virus Infections
Immunologic Factors
Rabies

Physiological Effects of Drugs
Rhabdoviridae Infections
Pharmacologic Actions
Immunoglobulins
Mononegavirales Infections

ClinicalTrials.gov processed this record on November 09, 2009