Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-01-13 @ 8:04 PM
Study NCT ID:
NCT02723812
Status:
COMPLETED
Last Update Posted:
2016-03-30
First Post:
2016-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate Safety of GCFLU® Administered Intramuscularly in Healthy Vietnamese Volunteer Aged From 3 Years Old
Sponsor:
Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
Organization:
Study Overview
Official Title:
A Bridging Study to Evaluate Safety of GCFLU® One Dose (0.5ml) (Seasonal Influenza Vaccine) Administered Intramuscularly in Healthy Vietnamese Volunteer Aged From 3 Years Old
Status:
COMPLETED
Status Verified Date:
2016-03
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:
None
Brief Summary:
An open label, non-comparative bridging study to evaluate the safety of GCFLU® (seasonal influenza vaccine) administered intramuscularly in healthy Vietnamese volunteer aged from 3 years old
Detailed Description:
A bridging study to evaluate safety of seasonal influenza vaccine GCFLU® pre-filled syringe inj. One dose (0.5 ml) after exposure administered intramuscularly. The study conducted in Ben Luc District of Long An province, in which 120 healthy Vietnamese volunteer aged from 5 year old will be enroll to the study. All subject will receive only one dose (0.5 ml) vaccine in Day 0.
Study variables will be collected to determine and provide the evidence for the safety of GCFLU®, include:
* Local and systemic adverse event (AE) in 30 minutes after vaccination.
* Local and systemic AE in 7 days after vaccination
* Unsolicited AE over 21 days after vaccination.
* Serious adverse event (SAE) after vaccination and in 21 days of observation periods Study protocol has been reviewed and approved by Pasteur Institute in Ho Chi Minh City (HCMC) Institutional Review Board (IRB), Vietnam Ministry of Health - Independent Ethics Committee (IEC) and Vietnam Minister of Health.
Study variables will be collected to determine and provide the evidence for the safety of GCFLU®, include:
* Local and systemic adverse event (AE) in 30 minutes after vaccination.
* Local and systemic AE in 7 days after vaccination
* Unsolicited AE over 21 days after vaccination.
* Serious adverse event (SAE) after vaccination and in 21 days of observation periods Study protocol has been reviewed and approved by Pasteur Institute in Ho Chi Minh City (HCMC) Institutional Review Board (IRB), Vietnam Ministry of Health - Independent Ethics Committee (IEC) and Vietnam Minister of Health.
Study Oversight
Has Oversight DMC:
False
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?: