To evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program over the five dose immunization program and the batches consistency of immunogenicity according to five dose immunization procedures.
* In the population aged 10-60 years, evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program (0, 3, 7, 14/28 days) over the five dose immunization program (0, 3, 7, 14, 28 days); * To evaluate the consistency of immunogenicity between batches of freeze-dried human rabies vaccine (Vero cell) inoculated according to five dose immunization procedures (0, 3, 7, 14, 28 days).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
2,100
The subjects were vaccinated with rabies vaccine according to different immunization procedures
Changchun Zhuoyi Biological Co., Ltd
Changchun, Jilin, China
Positive conversion rate of 14 days
\- 14 days after the first dose of inoculation, the positive conversion rate of serum neutralizing antibody.
Time frame: 6 months
Antibody Geometric Mean Titer (GMT) of 14 days
\- 14 days after the first dose of inoculation, the Geometric Mean Titer (GMT) of serum neutralizing antibody .
Time frame: 6 months
Positive conversion rate of 42 days
\- The seroconversion rate of serum neutralizing antibody that 42 days after the first dose of inoculation.
Time frame: 6 months
Advertise Events (AE) incidence within 1 month
\- The distribution of AE incidence in different time periods (including all, within 30 minutes, 0-3 days, 0-7 days, 8-30 days) after each dose of inoculation;
Time frame: 6 months
Serious Adverse Events (SAE) incidence within 6 months
\- Incidence rate of SAE within 6 months from the first dose of inoculation to the full course of inoculation.
Time frame: 12 months
Antibody test of 28 days
Detection of serum neutralizing antibody 28 days after the first dose of inoculation
Time frame: 6 months
Antibody GMT of 42 days
The serum neutralized antibody GMT 42 days after the first dose of inoculation;
Time frame: 6 months
Antibody test within 12 months
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The serum neutralizing antibody was detected in 3 timepoints within 12 months after the whole vaccination.
Time frame: 18months