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

Completed · Phase 3

Conditions studied: Rabies

In brief

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).

Key facts

Study ID

NCT02912845

Run by

Kamada, Ltd.

People needed

30

Starts

2016-08-01

Expected to finish

2019-11-13

Last updated by the study team

2021-09-05

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• ACH — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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