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
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
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 1, 2008
CompletedFirst Posted
Study publicly available on registry
July 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedMarch 20, 2012
March 1, 2012
5 months
July 1, 2008
March 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability
42 days
Secondary Outcomes (1)
Rabies virus neutralizing activity
42 days
Study Arms (2)
A
EXPERIMENTALCL184 combined with rabies vaccination
B
ACTIVE COMPARATORHRIG combined with rabies vaccination
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Institute for Tropical Medicine
Alabang, Muntinlupa, Metro Manila, Philippines
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beatriz P. Quiambao, MD
Research Institute for Tropical Medicine, Alabang, Muntinlupa, Metro Manila, Philippines
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2008
First Posted
July 2, 2008
Study Start
May 1, 2008
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
March 20, 2012
Record last verified: 2012-03