Evaluate Safety of GCFLU® Administered Intramuscularly in Healthy Vietnamese Volunteer Aged From 3 Years Old
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|ClinicalTrials.gov Identifier: NCT02723812|
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : March 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Influenza, Human||Biological: GCFLU® Influenza vaccine (Split virion, Inactivated)||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: GCFLU® Influenza vaccine (Split virion, Inactivated)
One dose 0.5 mL vaccine GCFLU® administered intramuscularly.
Biological: GCFLU® Influenza vaccine (Split virion, Inactivated)
Other Name: GCFLU® pre-filled syringe inj.
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723812
|Ben Luc Health centre|
|Ben Luc, Long An, Vietnam|
|Principal Investigator:||Thuong Nguyen Vu, PhD.||Pasteur Institute, Ho Chi Minh City|