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| Sponsor: | Crucell Holland BV |
|---|---|
| Information provided by: | Crucell Holland BV |
| ClinicalTrials.gov Identifier: | NCT00708084 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rabies |
Biological: CL184 Biological: HRIG |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety Study |
| 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 |
| Estimated Enrollment: | 48 |
| Study Start Date: | May 2008 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
CL184 combined with rabies vaccination
|
Biological: CL184
CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
|
|
B: Active Comparator
HRIG combined with rabies vaccination
|
Biological: HRIG
HRIG 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
|
Eligibility| Ages Eligible for Study: | 5 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Philippines | |
| Research Institute for Tropical Medicine | |
| Alabang, Muntinlupa, Metro Manila, Philippines | |
| Principal Investigator: | Beatriz P. Quiambao, MD | Research Institute for Tropical Medicine, Alabang, Muntinlupa, Metro Manila, Philippines |
More Information
| Responsible Party: | Crucell, Berna Biotech Ltd. ( Christophe Python/Clinical Development Manager ) |
| Study ID Numbers: | RAB-M-A004 |
| Study First Received: | July 1, 2008 |
| Last Updated: | July 31, 2009 |
| ClinicalTrials.gov Identifier: | NCT00708084 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Philippines: Department of Health |
|
Rabies post-exposure prophylaxis Monoclonal antibody |
|
Virus Diseases Antibodies RNA Virus Infections Immunologic Factors Rabies |
Physiological Effects of Drugs Rhabdoviridae Infections Pharmacologic Actions Immunoglobulins Mononegavirales Infections |