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

• Status: Completed
• Trial end date: 2019-11-13
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kamada, Ltd.
• Collaborator: Kedrion S.p.A.

Criteria

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