To evaluate immunogenicity consistency between three consecutive batches of commercial-scale productions for Sinovac Rabies vaccine
This clinical trial employed a randomized, double-blind design, enrolling a total of 912 participants aged 18 to 45 years. The investigational vaccine was the serum-free rabies vaccine produced by Sinovac. Eligible participants were enrolled and randomized in a 1:1:1 ratio into Trial group 1, Trial group 2, and Trial group 3, with 304 participants in each group. They received vaccination according to the Essen regimen (1-1-1-1-1) on days 0, 3, 7, 14, and 28, for a total of 5 doses of tjhree commercially scaled batches of the rabies vaccine. Blood samples will be collection at baseline before the first dose of immunization (D0), 14 days after the first dose (D14, before the third vaccination), and 14 days after the full course of immunization (D42), as well as 3, 6, and 12 months after the full course of immunization. All participants were required to complete immediate reaction observation within 30 minutes after each vaccine dose, and adverse events and serious adverse events were collected from the first dose of baseline immunization vaccination until 30 days after the last dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
912
Three batchs of Rabies Vaccine (Serum-free Vero Cell), Freeze-dried using five doses of PEP schedules
Mianzhu Municipal Center for Disease Control and Prevention
Deyang, China
Neijiang Municipal Center for Disease Control and Prevention
Neijiang, China
Geometric Mean Concentration (GMC) of rabies neutralizing antibodies among susceptible participants (RVNA titer <0.5 IU/mL before vaccination) in each group
Time frame: Day 14 after the first-dose vaccination
GMC of rabies neutralizing antibody
Time frame: Day 14 after the first-dose vaccination and at Day 14 after the full-course vaccination
Seroconversion Rate of rabies neutralizing antibody
Time frame: Day 14 after the first-dose vaccination and at Day 14 after the full-course vaccination
Incidence of adverse reactions
Time frame: Up to 30 days after the last-dose vaccination
Incidence of serious adverse events
Time frame: Up to 30 days after the last-dose vaccination
Seropositive Rate of rabies neutralizing antibody
Time frame: Month 3, 6, and 12 after the full-course vaccination
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