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.
All participants will receive five vaccinations (on Days 0, 3, 7, 14, and 28) and will be assessed for immunogenic response on Days 0, 14, and 42. They will also be monitored for safety from the day of the first vaccination and for up to 6 months after the final vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
816
0.5 mL, Intramuscular
0.5 mL, Intramuscular
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Unnamed facility
Nanning, Guangxi, China
Information on the rabies virus neutralizing antibody (RVNA) titer post vaccination
Rabies virus neutralizing antibody (RVNA) titer as determined by rapid fluorescent focus inhibition test (RFFIT)
Time frame: Day 14
Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post vaccination.
Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia.
Time frame: Day 1 up to 6 months post last vaccination
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