Ignite Creation Date:
2024-05-06 @ 7:31 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02541253
Status:
COMPLETED
Last Update Posted:
2016-11-06
First Post:
2015-08-28
Brief Title:
A Study to Evaluate the Efficacy and Safety of GC3110AQIV in Healthy Children
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
An Open-labelPart1 Single ArmPart1 RandomizedPart2 Double-blindPart2 Active-controlledPart2 Phase III Study to Evaluate the Efficacy and Safety of GC3110AQIV in Healthy Children
Status:
COMPLETED
Status Verified Date:
2016-11
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:
1 Part 1 If study subject and legal guardians who decide voluntarily to participate the clinical trial and sign the Informed Consent Form In the case of study subject less than 7 years of age written informed consent by study subjects legal guardians study subjects eligible for participating this trial protocol were assigned to test group and receiving the test drug 1 times or 2 times according to age
2 Part 2 If study subject and legal guardians who decide voluntarily to participate the clinical trial and sign the Informed Consent FormIn the case of study subject less than 7 years of age written informed consent by study subjects legal guardians the 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 drug 1 times or 2 times according to age as below
6 m 3 years
3 years 9 years
9 years 19 years
2 Part 2 If study subject and legal guardians who decide voluntarily to participate the clinical trial and sign the Informed Consent FormIn the case of study subject less than 7 years of age written informed consent by study subjects legal guardians the 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 drug 1 times or 2 times according to age as below
6 m 3 years
3 years 9 years
9 years 19 years
Detailed Description:
1 Part 1 If study subject and legal guardians who decide voluntarily to participate the clinical trial and sign the Informed Consent Form In the case of study subject less than 7 years of age written informed consent by study subjects legal guardians study subjects eligible for participating this trial protocol were assigned to test group and receiving the test drug 1 times or 2 times according to age
The safety data collected during part A will be reviewed by DSMB to evaluate the solicited adverse events for 7 days after each vaccination
However if no toxicity higher than grade 3 according to FDA guidance the study was allowed to proceed to Part 2 without DSMB review
Efficacy and safety assessment methods and visiting schedule will be the same as Part 2
2 Part 2 If study subject and legal guardians who decide voluntarily to participate the clinical trial and sign the Informed Consent FormIn the case of study subject less than 7 years of age written informed consent by study subjects legal guardians the 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 drug 1 times or 2 times according to age as below
6 m 3 years
3 years 9 years
9 years 19 years The investigator will evaluate the efficacy and safety of the test product while clinical trial
Blood samples will be collected at visit 1 for efficacy 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 of doses of 025mL or 05mL according to age will be intramuscularly injected However those who had not been vaccinated with influenza vaccine aged of over than 6 months to less than 9 years study subjects 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 12 Visit 34 and Visit 56
The safety data collected during part A will be reviewed by DSMB to evaluate the solicited adverse events for 7 days after each vaccination
However if no toxicity higher than grade 3 according to FDA guidance the study was allowed to proceed to Part 2 without DSMB review
Efficacy and safety assessment methods and visiting schedule will be the same as Part 2
2 Part 2 If study subject and legal guardians who decide voluntarily to participate the clinical trial and sign the Informed Consent FormIn the case of study subject less than 7 years of age written informed consent by study subjects legal guardians the 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 drug 1 times or 2 times according to age as below
6 m 3 years
3 years 9 years
9 years 19 years The investigator will evaluate the efficacy and safety of the test product while clinical trial
Blood samples will be collected at visit 1 for efficacy 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 of doses of 025mL or 05mL according to age will be intramuscularly injected However those who had not been vaccinated with influenza vaccine aged of over than 6 months to less than 9 years study subjects 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 12 Visit 34 and Visit 56
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