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

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.

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