NCT02912845

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2016

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2019

Completed
Last Updated

September 5, 2021

Status Verified

February 1, 2019

Enrollment Period

3.3 years

First QC Date

September 18, 2016

Last Update Submit

August 31, 2021

Conditions

Rabies

Outcome Measures

Primary Outcomes (2)

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

    Within 14 days from treatment

  • Frequency and severity of local and systemic SAEs occurring within 84 days of KamRAB treatment

    Within 84 days of treatment

Study Arms (1)

20 IU/kg KamRAB + Active Anti-Rabies Vaccine

EXPERIMENTAL
Drug: KamRAB - HRIG

Interventions

KamRAB - HRIGDRUG

wound infiltration or IM injection

20 IU/kg KamRAB + Active Anti-Rabies Vaccine

Eligibility Criteria

Age0 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ACH

Little Rock, Arkansas, 12345, United States

Location

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2016

First Posted

September 23, 2016

Study Start

August 1, 2016

Primary Completion

November 13, 2019

Study Completion

November 13, 2019

Last Updated

September 5, 2021

Record last verified: 2019-02

Locations

US(1)