Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT02723812
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:
NCT02723812
Study Brief:
Protocol Section:
NCT02723812