NCT00708084

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Crucell Holland BV · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rabies

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-07-02
• Last updated: 2012-03-20

Locations

1 site across 1 country: Philippines