- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Long An
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Ben Luc, Long An, Vietnam
- Ben Luc Health centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Subject must meet all criteria below to participate in study
- A person who is a 3-year-old or older, healthy and can be followed up for 21 days
- Subject who gave voluntary written consent to participate in the study, and able to comply with the study requirements. With subjects aged from 3 years to below 18 years, parents/legal representative will give voluntary consent to participate in this study, and subjects from 12 to under 18 years old will give voluntary written consent for children.
Exclusion Criteria:
Subject have one of criteria below must not participate in study
- Subject with a known hypersensitivity or allergic reaction to eggs or eggs products, to chicken or chicken products, to any component of the study vaccine, neomycin or gentamicin.
- Subjects with immune system disorder including immune deficiency disease.
- Subjects with a history of Guillain-Barre syndrome.
- Subjects with severe chronic disease (e.g.; cardiovascular disease except for controlled hypertension, respiratory disease, metabolic disease, renal/kidney dysfunction or hemoglobinopathy etc.) who in the investigator's opinion may have a difficulty in participating in the study.
- Subjects with hemophilia or receiving a treatment with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection.
- Subject who had acute fever with body temperature exceeding 37.50 Celsius (armpit calculated) before vaccination with the study drug.
- Subjects who had received other vaccination within 14 days before vaccination with the study drug, or those who had another vaccination scheduled during the study.
- Pregnant women, breast-feeding women or women of childbearing potential who do not use an appropriate method of contraception (use of condom, intrauterine contraceptive device, or hormone contraceptives, or of a male partner had vasectomy).
- Subjects who had participated in other clinical study within 28 days priors to vaccination with the study drug, or those who had another clinical trial scheduled during the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GCFLU® Influenza vaccine (Split virion, Inactivated)
One dose 0.5 mL vaccine GCFLU® administered intramuscularly.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety of GCFLU® by assessing the frequency, rate and severity of adverse events (local and general).
Time Frame: 30 minutes after vaccination.
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30 minutes after vaccination.
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Safety of GCFLU® by assessing the frequency, rate and severity of solicited adverse events (local and general)
Time Frame: For 7 days after vaccination.
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For 7 days after vaccination.
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Safety of GCFLU® by assessing the frequency, rate and severity of unsolicited adverse events.
Time Frame: During 21 days after vaccination.
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During 21 days after vaccination.
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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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During 21 days after vaccination.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thuong Nguyen Vu, PhD., Pasteur Institute, Ho Chi Minh City
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VX-2015.02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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