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
NCT ID: NCT00708084
Last Updated: 2012-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2008-05-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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A
CL184 combined with rabies vaccination
CL184
CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
B
HRIG combined with rabies vaccination
HRIG
HRIG 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
5 Years
17 Years
ALL
Yes
Sponsors
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Crucell Holland BV
INDUSTRY
Responsible Party
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Principal Investigators
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Beatriz P. Quiambao, MD
Role: PRINCIPAL_INVESTIGATOR
Research Institute for Tropical Medicine, Alabang, Muntinlupa, Metro Manila, Philippines
Locations
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Research Institute for Tropical Medicine
Alabang, Muntinlupa, Metro Manila, , Philippines
Countries
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Other Identifiers
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RAB-M-A004
Identifier Type: -
Identifier Source: org_study_id
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