Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06177249
Status:
COMPLETED
Last Update Posted:
2023-12-20
First Post:
2023-12-07
Brief Title:
To Evaluate the Immunogenicity and Safety of Two Different Immunization Schedules of Rabies Vaccine Vero Cell
Sponsor:
Hualan Biological Bacterin Co Ltd
Organization:
Hualan Biological Bacterin Co Ltd
Study Overview
Official Title:
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
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
rabies
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None