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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
120
Ben Luc Health centre
Bến Lức, Long An, Vietnam
Safety of GCFLU® by assessing the frequency, rate and severity of adverse events (local and general).
Time frame: 30 minutes after vaccination.
Safety of GCFLU® by assessing the frequency, rate and severity of solicited adverse events (local and general)
Time frame: For 7 days after vaccination.
Safety of GCFLU® by assessing the frequency, rate and severity of unsolicited adverse events.
Time frame: During 21 days after vaccination.
Safety of GCFLU® by assessing the frequency, rate and severity of serious adverse events.
Time frame: During 21 days after vaccination.
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