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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2019-11-13

Brief Summary

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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).

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Detailed Description

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Conditions

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Rabies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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20 IU/kg KamRAB + Active Anti-Rabies Vaccine

Group Type EXPERIMENTAL

KamRAB - HRIG

Intervention Type DRUG

wound infiltration or IM injection

Interventions

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KamRAB - HRIG

wound infiltration or IM injection

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

0 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No