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

NCT01930357 Phase 2 COMPLETED

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.

Details

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	Phase 2
Status	COMPLETED
Enrolment	342
Start date	2013-09
Completion	2015-06

Conditions

• Rabies

Interventions

• Purified Vero Rabies Vaccine Serum Free (VRVg)
• Imovax® Rabies: Human Diploid Cell Vaccine (HDCV),

Primary outcomes

• Number Subjects with rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL as measured by rapid fluorescent focus inhibition test (RFFIT) — Day 42
  Rabies virus neutralizing antibody will be measured by rapid fluorescent focus inhibition test (RFFIT)

Countries

Philippines