Clinical Trial: Purified Vero Rabies Vaccine-Serum Free Compared to Human Diploid Cell Vaccine in a Pre-exposure Prophylaxis Regimen
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free (VRVg) in Comparison With the Human Diploid Cell Vaccine, Imovax® Rab
Brief Summary:
The aim of the study is to document immunogenicity and safety of VRVg in a pre-exposure regimen in healthy children and adolescents aged 2 to 17 years.
Primary Objectives:
- To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international units (IU)/mL at D42, i.e. 14 days after the last vaccination.
- To describe if at least 99% of subjects achieve an RVNA titer ≥ 0.5 IU/mL at D42 with a lower bound of the 95% confidence interval (CI) of at least 97%, in the VRVg group.
Secondary Objectives:
- To assess the clinical safety of each vaccine after each vaccine injection when administered in a pre-exposure schedule.
- To describe the immune response induced by each vaccine 14 days after the last vaccination, i.e. at D42, and 6 months after the first vaccination
- To describe the geometric mean titer ratio between the two vaccine groups at D42, i.e. 14 days after the last vaccination.
