Study of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2011
This study is designed to gather safety and immunogenicity data with Purified Vero Rabies Vaccine - Serum Free (VRVg), when given in a post-exposure prophylaxis vaccination schedule, using the Essen regimen, across different populations. Primary Objective: * To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab vaccine, in terms of proportion of participants with a rabies virus neutralizing antibody titer ≥ 0.5 IU/mL at Day 14, i.e., before the fourth vaccination, in participants aged 10 to 17 years and in participants aged 18 years and over. Secondary Objectives: * To assess the clinical safety of VRVg after each vaccination when administered in a post-exposure prophylaxis vaccination schedule in each respective age group and overall * To describe the immune response induced by VRVg before the fourth vaccination and 14 days after the last vaccination in each respective age groups and overall.
Epistemonikos ID: 9aac4b27213680b168cb2a23b46f3b01a8361ba2
First added on: Mar 23, 2020