NCT06177249

To Evaluate the Immunogenicity and Safety of Two Different Immunization Schedules of Rabies Vaccine (Vero Cell)

Evaluation With Rabies Vaccine (Vero Cell) of Two Different Immune Procedure in the Healthy Crowd the Immunogenicity and Safety of Randomized, Blinded, Similar Vaccine Against Ⅲ Phase of Clinical Trials

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,956 (actual)
• Sponsor: Hualan Biological Bacterin Co. Ltd. · Industry
• Sex: All
• Age: 9 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Rabies Human

Interventions

Type	Name	Description
BIOLOGICAL	Control vaccine	A group of 652 subjects were vaccinated with the control vaccine at 0, 3, 7, 14 and 28 days (5 doses in total). Blood samples were collected from the subjects at 0, 7/14 and 35/42 days for antibody detection.
BIOLOGICAL	Experimental vaccine	A total of 652 subjects received 5 doses of the vaccine at 0, 3, 7, 14 and 28 days. Blood samples were collected on 0, 7/14 and 35/42 days for antibody detection.

Timeline

• Start date: 2015-03-15
• Primary completion: 2015-12-16
• Completion: 2016-05-01
• First posted: 2023-12-20
• Last updated: 2023-12-20

Locations

1 site across 1 country: China