Back to resultsRandomized 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
Primary Purpose
Rabies
Status
Completed
Phase
Phase 2
Locations
Philippines
Study Type
Interventional
Intervention
CL184
HRIG
Sponsored by
About this trial
This is an interventional treatment trial for Rabies focused on measuring Rabies post-exposure prophylaxis, Monoclonal antibody
Eligibility Criteria
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
Sites / Locations
- Research Institute for Tropical Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
CL184 combined with rabies vaccination
HRIG combined with rabies vaccination
Outcomes
Primary Outcome Measures
Safety and tolerability
Secondary Outcome Measures
Rabies virus neutralizing activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00708084
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Crucell Holland BV
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies
Keywords
Rabies post-exposure prophylaxis, Monoclonal antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
CL184 combined with rabies vaccination
Arm Title
B
Arm Type
Active Comparator
Arm Description
HRIG combined with rabies vaccination
Intervention Type
Biological
Intervention Name(s)
CL184
Intervention Description
CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
Intervention Type
Biological
Intervention Name(s)
HRIG
Intervention Description
HRIG 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
Primary Outcome Measure Information:
Title
Safety and tolerability
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Rabies virus neutralizing activity
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz P. Quiambao, MD
Organizational Affiliation
Research Institute for Tropical Medicine, Alabang, Muntinlupa, Metro Manila, Philippines
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Institute for Tropical Medicine
City
Alabang, Muntinlupa, Metro Manila
Country
Philippines
12. IPD Sharing Statement
Learn more about this 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
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