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Survey of Human Rabies Immune Globulin Safety in Children

NCT05382650 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2025-11-13

No results posted yet for this study

Summary

This observational study will be conducted across the Houston Methodist system, including all hospital-based and freestanding emergency departments (ED), and up to 4 additional sites in the United States. The safety of human rabies immune globulin (HRIG) 300 IU/mL product (HyperRAB®) in pediatric patients has not been fully established. The purpose of this study is to evaluate the safety of HRIG 300 IU/mL when given to pediatric patients per standard of care for rabies postexposure prophylaxis (PEP) in the ED.

Conditions

  • Rabies
  • Rabies Human
  • Rabies Virus Infection
  • Pediatrics

Interventions

BIOLOGICAL

Human rabies immune globulin 300 IU/mL

All participants in this single-cohort observational study will receive human rabies immune globulin 300 IU/mL at a dose of 20 IU/kg per standard of care.

Sponsors & Collaborators

  • Grifols Biologicals, LLC

    collaborator INDUSTRY

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Michael Sirimaturos, PharmD · The Methodist Hospital Research Institute

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-22
Primary Completion
2025-09-17
Completion
2025-10-15
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 NCT05382650 on ClinicalTrials.gov