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

NCT02912845 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-09-05

No results posted yet for this study

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).

Conditions

  • Rabies

Interventions

DRUG

KamRAB - HRIG

wound infiltration or IM injection

Sponsors & Collaborators

  • Kedrion S.p.A.

    collaborator INDUSTRY

  • Kamada, Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2019-11-13
Completion
2019-11-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02912845 on ClinicalTrials.gov