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Clinical Trial Summary

To evaluate the safety and immunogenicity of lyophilized human rabies vaccine (Vero cell) developed by Hualan Biological in healthy people aged 9 to 65 years with two different immunization schedules.


Clinical Trial Description

The trial to assess the rabies vaccine (Vero cells) in healthy group of 9 ~ 65 years old after inoculation, the first dose after 14 days and 14 days after inoculation 5 agent group turn antibody positive rate of bad effect on 5 agent in the control group; The safety profile, seroconversion rate, and geometric mean concentration of the four-dose vaccine were noninferior to those of the five-dose regimen at 14 days after the first dose. More people aged 9-65 in the first agent free after 7 days, 14 days and 14 days after inoculation, 5 patients and 5 doses in the control group, four patients and 5 doses group antibody positive rate, GMC and GMC growth multiples have differences. To evaluate whether the seroconversion rate of subjects in the 4-dose experimental group reached 100% 14 days after the whole course of vaccination. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06177249
Study type Interventional
Source Hualan Biological Bacterin Co. Ltd.
Contact
Status Completed
Phase Phase 3
Start date March 15, 2015
Completion date May 1, 2016

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