Ignite Creation Date:
2024-05-06 @ 3:46 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02360514
Status:
COMPLETED
Last Update Posted:
2015-02-10
First Post:
2015-02-03
Brief Title:
Study to Evalutate Long-term Immunity of Hantavax in High Risk Population of HFRS
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
Non-comparable and Open Clinical Research to Evaluate Long-term Immunity by Neutralizing Antibody Test of Adults in High Risk Population of HFRS Hemorrhagic Fever With Renal Syndrome After Vaccination and Booster Vaccination of Hantavax
Status:
COMPLETED
Status Verified Date:
2015-02
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:
None
Brief Summary:
This study was aimed evaluate long-term immunity response by neutralizing antibody test of adults in high risk population of HFRS
Detailed Description:
This clinical trial was designed as a multicenter non-comparable open-label clinical trialThis trial was conducted written informed consent form by voluntary agreement negative result of hantaanvirus antubidy by neutralizaing antibody test test drug was administrated 0 1 13 months according to drug label
For antibody test Sampling was conducted pre-doseT0 1 month after vaccinationT1 1 year after vaccinationbefore booster vaccination T2 and 1 month after vaccinationT3 Also 1 month after vaccination T3 after completion of booster vaccination for antibody retension duration observed for subjects with antibody to conduct a three-year follow-up survey was conducted and the antibody test every yearIn conclusion sampling was conducted 12 monthsT4 24 monthsT5 36monthsT6 after the booster vaccionation
However follow-up survey was terminated when the antibody titer was determined as a negative by neutralizing antibody test and fluorescent antibody technique
For antibody test Sampling was conducted pre-doseT0 1 month after vaccinationT1 1 year after vaccinationbefore booster vaccination T2 and 1 month after vaccinationT3 Also 1 month after vaccination T3 after completion of booster vaccination for antibody retension duration observed for subjects with antibody to conduct a three-year follow-up survey was conducted and the antibody test every yearIn conclusion sampling was conducted 12 monthsT4 24 monthsT5 36monthsT6 after the booster vaccionation
However follow-up survey was terminated when the antibody titer was determined as a negative by neutralizing antibody test and fluorescent antibody technique
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None