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Completed

NCT Number: NCT00708084

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

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.

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Key information

Conditions

Rabies Infections Mononegavirales Infections RNA Virus Infections Rhabdoviridae Infections Virus Diseases

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Institute for Tropical Medicine

Alabang, Muntinlupa, Metro Manila, Philippines

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CL184

Biological

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

HRIG

Biological

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

Primary outcomes

  1. Safety and tolerability

    Time frame: 42 days

Secondary outcomes

  1. Rabies virus neutralizing activity

    Time frame: 42 days

Sponsors and collaborators

Lead sponsor

Crucell Holland BV

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 2, 2008
Registry last updated
Mar 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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