This clinical trial is carried out in two phases. The first phase adopts an open design, and the second phase adopts a randomized, blinded, and similar vaccine-controlled non-inferiority trial design. The first stage: According to the order of two age groups of 18-60 years old and 10-17 years old, 40 cases were enrolled in each age group (20 persons for the 5-dose program and 20 for the 4-dose program). Subjects in the 5-dose group received 1 dose of test vaccine on 0, 3, 7, 14, and 28 days each. Subjects in the 4-dose group received 1 dose each on both arms on day 0, and 1 dose on day 7 and day 21 each. All subjects in the first stage were only observed for safety and were followed up to 6 months after the entire course of vaccination. The second stage: the total number of enrolled 2400 cases, 10-60 years old, the 4-dose program group and the 5-dose program group of the test vaccine, the 4-dose program group and the 5-dose program group of the control vaccine according to the random ratio 1:1:1:1. Among the total number of participants, 1680 cases (420 cases per group) were simultaneously observed for immunogenicity and safety, and the remaining 720 subjects (180 cases per group) only underwent safety observation. 800 subjects (200 cases in each group) received 6-month immune persistence observation after full vaccination, and 400 subjects in the test vaccine group received 12 months immune persistence observation after full vaccination. In the second stage, 1680 subjects were collected before the immunization, 7 days after the first dose, 14 days after the first dose, and 14 days after the full vaccination to test rabies virus antibodies to evaluate the immunogenicity of the test vaccine. 800 subjects were in the whole process Immune persistent blood sampling was performed 6 months after vaccination, and subjects in the test vaccine group were further subjected to immune persistent blood sampling 12 months after the full course of vaccination to evaluate immune durability. Collect all AEs within 30 minutes after each dose, AEs from 0-7 days, all non-collective AEs from the first dose to 30 days after the full course of vaccination, and all serious AEs from the first dose to 6 months after the full course of vaccination Adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,480
Inoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm
Inoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm
Inoculate 1 dose of control vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm
Inoculate 1 dose of control vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China
Antibody positive conversion rate - Immunogenicity endpoint
Antibody positive conversion rate of the test group and the control group of the pre-immune antibody-negative population
Time frame: 14 days after the first dose of vaccination
Geometric mean concentration - Immunogenicity endpoint
Geometric mean concentration of the test group and the control group of the pre-immune antibody-negative population
Time frame: 14 days after the first dose of vaccination
Incidence of Adverse Events [Safety and Tolerability]
Incidence of Adverse Events
Time frame: within 30 minutes after each dose of vaccination; the first dose of vaccination to 30 days after the full course of vaccination
Incidence of Serious Adverse Events [Safety and Tolerability]
Incidence of Serious Adverse Events
Time frame: The first dose of vaccination to 6 months after the full course of vaccination
Antibody positive conversion rate - Immunogenicity endpoint
Antibody positive conversion rate
Time frame: 7 days after the first dose of vaccination; 14 days, 6 months, 12 months after the full vaccination
Geometric mean concentration - Immunogenicity endpoint
Geometric mean concentration
Time frame: 7 days after the first dose of vaccination; 14 days, 6 months, 12 months after the full vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.