Survey of Human Rabies Immune Globulin Safety in Children

November 11, 2025 updated by: Michael Sirimaturos, The Methodist Hospital Research Institute

Multicenter Safety Evaluation of Human Rabies Immune Globulin 300 IU/mL in Children

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND: Rabies PEP consists of thorough wound cleansing, administration of HRIG 20 IU/kg body weight, and 4 to 5 doses of rabies vaccine. The safety of HRIG 300 IU/mL has been confirmed only for adult patients. Although the safety of HRIG 300 IU/mL in the pediatric population has not been fully established, there is no age limit on the FDA approved indication for HRIG 300 IU/mL, and it is routinely administered to pediatric patients as standard of care in the United States.

STUDY DESIGN: This observational, multicenter, prospective study will collect information on safety events that occur up to 30 days after standard of care administration of HRIG 300 IU/mL among pediatric patients (age ≤17 years) at up to 5 study sites in the United States. Safety data will be collected using surveys and chart review of the health record. All participants will receive HRIG 300 IU/mL per standard of care prior to joining this study. The day of HRIG 300 IU/mL administration will be defined as day 0. The study will conduct Survey 1 on day 2 and Survey 2 on day 10 to collect information on adverse events (AEs). Investigators will review the electronic health record on day 30 to collect additional information on AEs. If a serious adverse event is detected during Survey 1, Survey 2, or the 30-day chart review and is not previously documented as being resolved or stabilized the study will conduct Survey 3 on day 30.

Study Type

Observational

Enrollment (Actual)

35

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
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital

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

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients who received HRIG 300 IU/mL as part of routine medical care for rabies PEP during an ED visit in up to 5 study sites in the United States

Description

Inclusion Criteria

  1. Received HRIG 300 IU/mL for rabies PEP during an ED encounter visit
  2. Aged ≤17 years

Exclusion Criteria

  1. HRIG 300 IU/mL dose given is <18 IU/kg or >22 IU/kg
  2. Patient is admitted or transferred to a hospital from the ED for further management of injuries related to the animal exposure
  3. Patient has a history of rabies vaccine or rabies immune globulin administration
  4. Legally authorized representative (parent) does not speak English if patient is <7 years old
  5. Legally authorized representative (parent) or patient does not speak English if patient is 7 to 17 years old

  6. Inability to obtain consent

    1. More than 3 days passed since HRIG 300 IU/mL administration prior to screen
    2. Unable to contact legally authorized representative (parent) and/or patient within 3 days of HRIG 300 IU/mL administration
    3. Legally authorized representative (parent) and/or patient declined participation
  7. Administration sites for HRIG are 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of local and systemic adverse events (AEs) within 2 days of HRIG 300 IU/mL administration
Time Frame: Within 2 days of HRIG 300 IU/mL administration
Proportion of patients with 1 or more AEs deemed as possibly/definitely related to HRIG 300 IU/mL administration
Within 2 days of HRIG 300 IU/mL administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of all local and systemic AEs within 10 days of HRIG 300 IU/mL administration
Time Frame: Within 10 days of HRIG 300 IU/mL administration
Proportion of patients with 1 or more AEs deemed as possibly/definitely related to HRIG 300 IU/mL administration
Within 10 days of HRIG 300 IU/mL administration
Cumulative incidence of all local and systemic AEs within 30 days of HRIG 300 IU/mL administration
Time Frame: Within 30 days of HRIG 300 IU/mL administration
Proportion of patients with 1 or more AEs deemed as possibly/definitely related to HRIG 300 IU/mL administration
Within 30 days of HRIG 300 IU/mL administration
Cumulative incidence of all local and systemic serious adverse events (SAEs) within 30 days of HRIG 300 IU/mL administration
Time Frame: Within 30 days of HRIG 300 IU/mL administration

Proportion of patients with 1 or more SAE deemed as possibly/definitely related to HRIG 300 IU/mL administration. An AE is considered "serious" if any of the following outcomes occur:

  • Death
  • Life-threatening AE (life-threatening in the definition of "serious" refers to an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe)
  • In-patient hospitalization or prolongation of existing hospitalization
  • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
  • An important medical event (refers to events which may not be immediately life-threatening, or result in death, or hospitalization, but from medical and scientific judgment, may jeopardize the participant or/and may require medical or surgical intervention to prevent one of the other outcomes listed above).
Within 30 days of HRIG 300 IU/mL administration
Type and severity of individual local and systemic AEs detected within 30 days of HRIG 300 IU/mL administration
Time Frame: Within 30 days of HRIG 300 IU/mL administration
Proportions of AEs that are local vs systemic and proportions of AEs that are mild, moderate, or severe among AEs deemed as possibly/definitely related to HRIG 300 IU/mL administration
Within 30 days of HRIG 300 IU/mL administration

Collaborators and Investigators

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

Sponsor

The Methodist Hospital Research Institute

Collaborators

Grifols Biologicals, LLC

Investigators

  • Principal Investigator: Michael Sirimaturos, PharmD, The Methodist Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

February 22, 2023

Primary Completion (Actual)

September 17, 2025

Study Completion (Actual)

October 15, 2025

Study Registration Dates

First Submitted

April 28, 2022

First Submitted That Met QC Criteria

May 16, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Estimated)

November 13, 2025

Last Update Submitted That Met QC Criteria

November 11, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00028137

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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