The purpose of this study is to generate data in human on immunogenicity and safety of Purified Vero Rabies Vaccine (VRVg) in support of the vaccine registration. Primary Objective: * To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab, in terms of seroconversion rate at Day 42 of the primary vaccination series. Secondary Objectives: * To assess the clinical safety of VRVg after each vaccination when administered in a pre-exposure vaccination schedule with a booster at 12 months after the first vaccination in all subjects. * To describe the immune response induced by VRVg 21 days after two vaccinations in a subset of randomized subjects and 14 days after the last vaccination of the primary vaccination series.
All subjects will receive three vaccinations for primary series and a booster vaccination at 12 months after the first vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
384
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Unnamed facility
Gières, France
Unnamed facility
Montpellier, France
Unnamed facility
Pierre-Bénite, France
Unnamed facility
Poitiers, France
Unnamed facility
Rennes, France
Unnamed facility
Rueil-Malmaison, France
To provide information concerning the immunogenicity of Purified Vero Rabies Vaccine.
Time frame: 42 days post-primary series vaccination
To provide information concerning the safety after Purified Vero Rabies Vaccine.
Time frame: 0 to 7 days post-vaccination and entire study duration
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