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 - Tabular View

Tracking Information

First Received Date ^ICMJE

July 1, 2008

Last Updated Date

July 31, 2009

Start Date ^ICMJE

May 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and tolerability [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00708084 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety Study

Condition ^ICMJE

Rabies

Intervention ^ICMJE

Biological: CL184
Biological: HRIG

Study Arms / Comparison Groups

Experimental: CL184 combined with rabies vaccination
Active Comparator: 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 ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

October 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Philippines

Administrative Information

NCT ID ^ICMJE

NCT00708084

Responsible Party

Christophe Python/Clinical Development Manager, Crucell, Berna Biotech Ltd.

Study ID Numbers ^ICMJE

RAB-M-A004

Study Sponsor ^ICMJE

Crucell Holland BV

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Beatriz P. Quiambao, MD

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

Information Provided By

Crucell Holland BV

Verification Date

July 2009

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