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

August 31, 2021 updated by: Kamada, Ltd.
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 12345
        • ACH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 20 IU/kg KamRAB + Active Anti-Rabies Vaccine
Drug: KamRAB - HRIG
wound infiltration or IM injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment
Time Frame: Within 14 days from treatment
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
Within 84 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kamada, Ltd.

Collaborators

Kedrion S.p.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

November 13, 2019

Study Completion (Actual)

November 13, 2019

Study Registration Dates

First Submitted

September 18, 2016

First Submitted That Met QC Criteria

September 22, 2016

First Posted (Estimate)

September 23, 2016

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KamRAB-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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