To demonstrate the immunogenicity of Sinovac rabies vaccine is non-inferior to the active-controlled rabies vaccine (Verorab®) after pre-exposure prophylaxis (PrEP) vaccination, and to confirm its satisfying safety profile in the pediatric and adult population in a PrEP schedule
This is a Phase Ⅲ, randomized, double-blind, active-controlled study. A total of 390 healthy participants aged ≥1 years old will be enrolled. All participants will be randomized at a 2:1 ratio to receive Sinovac rabies vaccine (Trial group) or Sanofi Pasteur Verorab® (Control group), in a three doses of PrEP schedule at Day 0, Day 7 and Day 28 through intramuscular route (IM) that covers a two doses of IM PrEP schedule at Day 0, Day 7 as well. Blood samples for immunogenicity assessment will be collected at Day 0, Day 28, and Day 42. For immunogenicity assessment, the blood sample at Day 28 will be used for the two-doses IM PrEP schedule, and the blood sample at Day 42 will be used for the three-doses IM PrEP schedule, in comparison with the active-control vaccine Verorab®. For safety assessment, the solicited local and systemic adverse events (AEs) within 7 days after each-dose vaccination (If the vaccination interval is less than 7 days, the actual interval shall prevail), as well as unsolicited AEs from the first-dose vaccination until 28 days after the last-dose vaccination will be actively monitored. Serious adverse events (SAEs) will also be collected during the whole study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
390
Receiving three doses of rabies vaccine rabies vaccine manufactured by Sinovac using a three-dose PrEP schedule
Receiving three doses of marketed rabies vaccine manufactured by Sanofi using the three-dose PrEP schedule
Al-Shifa Trust Eye Hospital
Rawalpindi, Pakistan
Proportion of participants achieving a RVNA titer ≥0.5 IU/mL
Time frame: Day 42 after the first dose of vaccination
Proportion of participants achieving a RVNA titer ≥0.5 IU/mL
Time frame: Day 28 after the first dose of vaccination
GMCs of RVNA titers
Time frame: Day 28 and Day 42 after the first dose of vaccination
Incidence of adverse reactions
Time frame: Up to 28 days after the last-dose vaccination
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