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

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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

This Tabular View shows the required WHO registration data elements as marked by ^†

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 ^†

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.