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NCT00708084 Clinical Trial

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

Rabies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00708084
Other study ID # RAB-M-A004
Secondary ID
Status Completed
Phase Phase 2
First received July 1, 2008
Last updated March 19, 2012
Start date May 2008
Est. completion date October 2008

Study information
Verified date March 2012
Source Crucell Holland BV
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationPhilippines: Department of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 17 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Philippines Research Institute for Tropical Medicine Alabang, Muntinlupa, Metro Manila

Sponsors (1)
Lead Sponsor Collaborator
Crucell Holland BV

Country where clinical trial is conducted

Philippines, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability 42 days Yes
Secondary Rabies virus neutralizing activity 42 days No
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