Trial | NCT00708084  Report issue

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
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    48
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.
Study Started
May 31
2008
Primary Completion
Oct 31
2008
Study Completion
Oct 31
2008
Last Update
Mar 20
2012
Estimate

Biological CL184

CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28

Biological HRIG

HRIG 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28

A Experimental

CL184 combined with rabies vaccination

B Active Comparator

HRIG combined with rabies vaccination

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
No Results Posted