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NCT02912845 Clinical Trial

Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies

Rabies Clinical Trial

Official title:
Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02912845
Other study ID # KamRAB-004
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 1, 2016
Est. completion date November 13, 2019

Study information
Verified date February 2019
Source Kamada, Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date November 13, 2019
Est. primary completion date November 13, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 17 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• KamRAB - HRIG
wound infiltration or IM injection

Locations
Country Name City State
United States ACH Little Rock Arkansas

Sponsors (2)
Lead Sponsor Collaborator
Kamada, Ltd. Kedrion S.p.A.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment Within 14 days from treatment
Primary Frequency and severity of local and systemic SAEs occurring within 84 days of KamRAB treatment Within 84 days of treatment
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