NCT02723812

Evaluate Safety of GCFLU® Administered Intramuscularly in Healthy Vietnamese Volunteer Aged From 3 Years Old

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	GCFLU® Influenza vaccine (Split virion, Inactivated)

Timeline

• Start date: 2015-11-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2016-03-30
• Last updated: 2016-03-30

Locations

1 site across 1 country: Vietnam