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

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

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).

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