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

Kamada

Status and phase: Completed; Phase 3

Conditions: Rabies

Treatments: Drug: KamRAB - HRIG

Study type: Interventional

Funder types: Industry

Identifiers

NCT02912845

KamRAB-004

Details and patient eligibility

About

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).

Enrollment: 30 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

20 IU/kg KamRAB + Active Anti-Rabies Vaccine

Experimental group

Treatment:

Drug: KamRAB - HRIG