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).

Completed

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Key information

Conditions

Rabies Infections Mononegavirales Infections RNA Virus Infections Rhabdoviridae Infections Virus Diseases

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ACH

Little Rock, Arkansas, 12345, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KamRAB - HRIG

Drug

wound infiltration or IM injection

Primary outcomes

Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment

Time frame: Within 14 days from treatment
Frequency and severity of local and systemic SAEs occurring within 84 days of KamRAB treatment

Time frame: Within 84 days of treatment

Sponsors and collaborators

Lead sponsor

Kamada, Ltd.

Industry

Collaborators

Kedrion S.p.A.

Registry information

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Sep 23, 2016
Registry last updated: Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed