Rabies Clinical Trial
Official title:
Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free (VRVg) in Comparison With the Human Diploid Cell Vaccine, Imovax® Rabies in a Pre-exposure Prophylaxis Regimen in Healthy Children and Adolescents Aged 2 to 17 Years
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.
Participants will receive a total of three vaccinations, one each at Day 0, Day 7, and Day
28, respectively, and will be assessment for immune response to rabies vaccine before the
first injection (baseline titer), at Day 42, and at Month 6.
Safety will be assessed in all participants up to 28 days after each injection. Serious
adverse events and adverse events of special interest (AESIs) will be collected up to 6
months after the last injection.
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