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

Phase 3

Completed

• Conditions: Rabies
• Interventions: Drug: KamRAB - HRIG

• 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

Study Timeline

• Study Start: 2016-08-01
• Study First Submitted: 2016-09-18
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-23
• Status Verified: 2019-02
• Primary Completion: 2019-11-13
• Study Completion: 2019-11-13
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-05

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

Trial Locations

Locations (1)

ACH; 🇺🇸 Little Rock, Arkansas, United States