Randomized Phase II Trial on Safety and Neutralizing Activity of CL184 and Rabies Vaccine Versus Human Rabies Immune Globulin (HRIG) and Rabies Vaccine in Children and Adolescents

A Single-blind, Randomized, Monocentric Phase II Trial to Explore the Safety and Rabies-neutralizing Activity of Combined Administration of CL184 and Rabies Vaccine Versus Human Rabies Immune Globulin Plus Rabies Vaccine in Simulated Rabies Post-exposure Prophylaxis in Children and Adolescents

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00708084

Enrollment

Registered

2008-07-02

Start date

2008-05-31

Completion date

2008-10-31

Last updated

2012-03-20

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

Conditions

Rabies

Keywords

Rabies post-exposure prophylaxis, Monoclonal antibody

Brief summary

The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in combination with rabies vaccine compared with human rabies immune globulin (HRIG) in combination with rabies vaccine in healthy children and adolescents.

Interventions

BIOLOGICALCL184

CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28

BIOLOGICALHRIG

HRIG 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

5 Years to 17 Years

Healthy volunteers

Yes

Inclusion criteria

* Subjects free of obvious health-problems or with stable conditions * Male or female subject aged ≥5 to ≤18 years * Subject is living, studying, or working close to the study referral site * Parent or legal representative signed written informed consent; in addition for subjects ≥12 years: signed assent form

Exclusion criteria

* Prior history of rabies exposure or immunization (rabies vaccine and/or immune globulin) * Acute infection or disease within the last 2 weeks * History and/or family history of clinically significant immunodeficiency or auto-immune disease * Any history of known or suspected anaphylaxis or hypersensitivity reaction * Planned immunization with live vaccines during the next 3 months * Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product

Design outcomes

Primary

Measure	Time frame
Safety and tolerability	42 days

Secondary

Measure	Time frame
Rabies virus neutralizing activity	42 days

Countries

Philippines

Outcome results

None listed

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