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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02912845

Enrollment

Registered

2016-09-23

Start date

2016-08-01

Completion date

2019-11-13

Last updated

2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rabies

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).

Interventions

DRUGKamRAB - HRIG

wound infiltration or IM injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026