Back to resultsPost-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies
Primary Purpose
Rabies
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
KamRAB - HRIG
Sponsored by
About this trial
This is an interventional treatment trial for Rabies
Eligibility Criteria
Inclusion Criteria:
- Healthy children (male and female) ages 0 months to <17 years.
- Have been exposed or possibly exposed to rabies.
- Are indicated to receive post-exposure prophylaxis (PEP) against rabies infection.
- Have documented informed consent from the child's parent(s) or legal guardian(s) and assent from the child if appropriate.
Exclusion Criteria:
- History of previous administration of rabies vaccine or human rabies immune globulin (HRIG)
- Rabies exposure or possible rabies exposure more than seven days prior to initiation of PEP, or timing of exposure unknown
Sites / Locations
- ACH
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
20 IU/kg KamRAB + Active Anti-Rabies Vaccine
Arm Description
Outcomes
Primary Outcome Measures
Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment
Frequency and severity of local and systemic SAEs occurring within 84 days of KamRAB treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT02912845
First Posted
September 18, 2016
Last Updated
August 31, 2021
Sponsor
Kamada, Ltd.
Collaborators
Kedrion S.p.A.
1. Study Identification
Unique Protocol Identification Number
NCT02912845
Brief Title
Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies
Official Title
Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
November 13, 2019 (Actual)
Study Completion Date
November 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kamada, Ltd.
Collaborators
Kedrion S.p.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this study is to confirm the safety of KamRAB (Human Rabies Immunoglobulin) in children ages 0 months to <17 years, when administered as part of post-Rabies Exposure Prophylaxis (PEP).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
20 IU/kg KamRAB + Active Anti-Rabies Vaccine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KamRAB - HRIG
Intervention Description
wound infiltration or IM injection
Primary Outcome Measure Information:
Title
Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment
Time Frame
Within 14 days from treatment
Title
Frequency and severity of local and systemic SAEs occurring within 84 days of KamRAB treatment
Time Frame
Within 84 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy children (male and female) ages 0 months to <17 years.
Have been exposed or possibly exposed to rabies.
Are indicated to receive post-exposure prophylaxis (PEP) against rabies infection.
Have documented informed consent from the child's parent(s) or legal guardian(s) and assent from the child if appropriate.
Exclusion Criteria:
History of previous administration of rabies vaccine or human rabies immune globulin (HRIG)
Rabies exposure or possible rabies exposure more than seven days prior to initiation of PEP, or timing of exposure unknown
Facility Information:
Facility Name
ACH
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
12345
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies
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