Ignite Creation Date:
2024-05-06 @ 10:31 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03285997
Status:
UNKNOWN
Last Update Posted:
2017-09-18
First Post:
2017-09-13
Brief Title:
A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Infants From 6 Months to 35 Months of Age
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Infants From 6 Months to 35 Months of Age
Status:
UNKNOWN
Status Verified Date:
2017-09
Last Known Status:
NOT_YET_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:
If study subjects legal guardians who decide voluntarily to participate the clinical trial and sign the Informed Consent Formed study subjects eligible for participating this trial protocol were assigned to test group or control group with the ratio of 41 and receiving the test or control drug 1 time or 2 times
Detailed Description:
1 Part 1 If study subjects legal guardians who decide voluntarily to participate the clinical trial and sign the Informed Consent Form study subjects eligible for participating this trial protocol were assigned to test group and receiving the test drug 1 time or 2 times
2 Part 2 If study subjects legal guardians who decide voluntarily to participate the clinical trial and sign the Informed Consent Formed study subjects eligible for participating this trial protocol were assigned to test group or control group with the ratio of 41 and receiving the test or control drug 1 time or 2 times
The investigator will evaluate the efficacy and safety of the test product while clinical trial
Blood samples will be collected at visit 1 and visit 5 for immunogenicity evaluation The study subject and their legal guardians will be educated to daily record AEs after vaccination on the patient diary to evaluate the safety
At visit1 blood samples will be collected from randomized study subjects and investigational drug will be intramuscularly injected However those who had not been vaccinated with influenza vaccine will re-visit and have the 2nd vaccination 45 weeks after the 1st vaccination
After 45 weeks since last vaccination study subjects will visit and blood sample will be collected And the serious adverse events occurred during 180 days after the final vaccination will be checked through the telephone visit
The study subjects with 1 dose of vaccine will have 4 visits including Visit 12 and Visit 56 The study subjects with 2 dose of vaccine will have 6 visits including Visit 34
2 Part 2 If study subjects legal guardians who decide voluntarily to participate the clinical trial and sign the Informed Consent Formed study subjects eligible for participating this trial protocol were assigned to test group or control group with the ratio of 41 and receiving the test or control drug 1 time or 2 times
The investigator will evaluate the efficacy and safety of the test product while clinical trial
Blood samples will be collected at visit 1 and visit 5 for immunogenicity evaluation The study subject and their legal guardians will be educated to daily record AEs after vaccination on the patient diary to evaluate the safety
At visit1 blood samples will be collected from randomized study subjects and investigational drug will be intramuscularly injected However those who had not been vaccinated with influenza vaccine will re-visit and have the 2nd vaccination 45 weeks after the 1st vaccination
After 45 weeks since last vaccination study subjects will visit and blood sample will be collected And the serious adverse events occurred during 180 days after the final vaccination will be checked through the telephone visit
The study subjects with 1 dose of vaccine will have 4 visits including Visit 12 and Visit 56 The study subjects with 2 dose of vaccine will have 6 visits including Visit 34
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