Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies
- Registration Number
- NCT02912845
- Lead Sponsor
- Kamada, Ltd.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 20 IU/kg KamRAB + Active Anti-Rabies Vaccine KamRAB - HRIG -
- Primary Outcome Measures
Name Time Method Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment Within 14 days from treatment Frequency and severity of local and systemic SAEs occurring within 84 days of KamRAB treatment Within 84 days of treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
ACH
🇺🇸Little Rock, Arkansas, United States