Ignite Creation Date:
2024-05-06 @ 7:32 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02553837
Status:
UNKNOWN
Last Update Posted:
2016-02-02
First Post:
2015-09-13
Brief Title:
Study to Evaluate the Immunogenicity and Safety of Hantavax in Healthy Adult
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
Study to Evaluate the Immunogenicity and Safety of Hantavax in Healthy Adult
Status:
UNKNOWN
Status Verified Date:
2015-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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 to evaluate the Immunogenicity and Safety response by vaccinating Hantavax in Healthy Adult
Detailed Description:
This clinical trial was designed as a multicenter non-comparative open-label clinical trial This trial was conducted written informed consent form by voluntary agreement the subjects who have not had the hantavax vaccination history at the time of screening Investigator product was administrated 0 1 2 13 months
For antibody test Sampling was conducted pre-doseT0 28 days after the 2nd vaccinationbefore the 3rd vaccination T1 28 days after the 3rd vaccinationT2 and 11 months after the 3rd vaccinationbefore booster vaccination T3 28 days after the booster vaccinationT4 2 months after the booster vaccinationT5 and 4 months after the booster vaccinationT6 Also after the completion of booster vaccination for antibody retention duration observed for subjects with antibody to conduct a five-year follow-up survey was conducted and the antibody test every year In conclusion sampling was conducted 12 monthsT7 24 monthsT8 36monthsT9 48 monthsT10 60 monthsT11 after the booster vaccination
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 28 days after the 2nd vaccinationbefore the 3rd vaccination T1 28 days after the 3rd vaccinationT2 and 11 months after the 3rd vaccinationbefore booster vaccination T3 28 days after the booster vaccinationT4 2 months after the booster vaccinationT5 and 4 months after the booster vaccinationT6 Also after the completion of booster vaccination for antibody retention duration observed for subjects with antibody to conduct a five-year follow-up survey was conducted and the antibody test every year In conclusion sampling was conducted 12 monthsT7 24 monthsT8 36monthsT9 48 monthsT10 60 monthsT11 after the booster vaccination
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