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

Phase 2

Completed

• Conditions: Rabies
• Interventions: Biological: CL184; Biological: HRIG

• Registration Number: NCT00708084
• Lead Sponsor: Crucell Holland BV

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

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-07-01
• Study First Submitted QC: 2008-07-01
• Study First Posted: 2008-07-02
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Disposition First Submitted: 2009-07-31
• Disposition First Submitted QC: 2009-07-31
• Disposition First Posted: 2009-08-10
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-19
• Last Update Posted: 2012-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	CL184	CL184 combined with rabies vaccination
B	HRIG	HRIG combined with rabies vaccination

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	42 days

Secondary Outcome Measures

Name	Time	Method
Rabies virus neutralizing activity	42 days

Trial Locations

Locations (1)

Research Institute for Tropical Medicine; 🇵🇭 Alabang, Muntinlupa, Metro Manila, Philippines