NCT02912845CompletedPhase 3
Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Kamada, Ltd.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 0 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
20 IU/kg KamRAB + Active Anti-Rabies Vaccine
Experimental
Intervention: KamRAB - HRIG (Drug)
Outcomes
Primary Outcomes
Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment
Time Frame: Within 14 days from treatment
Frequency and severity of local and systemic SAEs occurring within 84 days of KamRAB treatment
Time Frame: Within 84 days of treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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