A Study to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
GC FLU Quadrivalent
Fluarix Tetra
Sponsored by
About this trial
This is an interventional prevention trial for Influenza
Eligibility Criteria
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Either gender, aged 20 to 50 years old (inclusive)
- Willing and able to comply with all the required study visits and follow-up defined by this protocol
Female subject with childbearing potential or male subject with female spouse/partner with childbearing potential must agree to use highly effective contraceptives from 15 days prior to vaccination until 60 days after vaccination. At least two forms of birth control must be adopted and one of which must be a barrier method. Acceptable forms include:
- Established use of oral, injected or implanted hormonal methods of contraception
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: condom, or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
Exclusion Criteria:
- With previous known or potential exposure to influenza virus within 12 weeks prior to vaccination
- Received seasonal influenza vaccine (registered or investigational) within 24 weeks prior to vaccination
- Received any vaccine other than seasonal influenza vaccine within 6 weeks prior to vaccination
- Received other investigational products (including medications and vaccines) within 6 weeks prior to vaccination
- Administered immunoglobulins and/or other blood products within the 12 weeks prior to vaccination
- Known or suspected hypersensitivity to any component of vaccines (including egg proteins); or history of allergy to consumption of eggs
- History of inflammatory or degenerative neurological disease (e.g., Guillain-Barre syndrome)
- With confirmed or suspected immunosuppressive or immunodeficient condition (e.g. HIV infection), or received > 14 days of systemic steroid with equivalent dosage equal or over to 0.5 mg/kg/day prednisolone or other immune-modifying agents within 24 weeks prior to vaccination
- Positive in HIV, HBsAg, or HCV test
- With fever (defined as body temperature equal or over to 38 °C by any method) on the day of vaccination
- With ongoing acute diseases or within the past 2 years serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the subject
- Female subject who is lactating or has positive serum or urine pregnancy test at screening or vaccination
Sites / Locations
- National Taiwan University Hospital
- Taipei Municipal Wan Fang Hospital
- Tri-Service General Hospital
- Linkou Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GC Flu Quadrivalent
Fluarix tetra
Arm Description
Outcomes
Primary Outcome Measures
The Geometric Mean Titer (GMT) Ratio
The non-inferior immunogenicity of GC FLU compared to active control in terms of HAI titers against each virus strain at 21 days after the vaccination.
The Seroconversion Rate
The non-inferior immunogenicity of GC FLU compared to active control in terms of HAI titers against each virus strain at 21 days after the vaccination.
Secondary Outcome Measures
Full Information
NCT ID
NCT03718468
First Posted
October 22, 2018
Last Updated
August 12, 2019
Sponsor
Medigen Vaccine Biologics Corp.
1. Study Identification
Unique Protocol Identification Number
NCT03718468
Brief Title
A Study to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine
Official Title
A Phase III, Prospective, Randomized, Open-Labeled, Active-Controlled, Multi-Center Study to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine, GC FLU, in Adults Aged 20 to 50
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
July 3, 2019 (Actual)
Study Completion Date
July 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medigen Vaccine Biologics Corp.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aims to demonstrate the immunogenic efficacy of GC FLU Quadrivalent Pre-filled Syringe inj. (GC FLU), a quadrivalent influenza virus vaccine, is non-inferior to the active control, Fluarix Tetra. This study is designed to be a randomized, open-labelled, active-controlled, parallel, phase III study recruiting subjects from multiple study sites.
Approximately 840 eligible subjects are planned to enroll in order to obtain 800 evaluable (= per-protocol) subjects. Subjects will be randomized and assigned to GC FLU or Fluarix Tetra (active control, AC) group in 1:1 ratio.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
842 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GC Flu Quadrivalent
Arm Type
Experimental
Arm Title
Fluarix tetra
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
GC FLU Quadrivalent
Intervention Description
A single dose administration of GC FLU Quadrivalent will be through intramuscular injection.
Intervention Type
Biological
Intervention Name(s)
Fluarix Tetra
Intervention Description
A single dose administration of Fluarix Tetra will be through intramuscular injection.
Primary Outcome Measure Information:
Title
The Geometric Mean Titer (GMT) Ratio
Description
The non-inferior immunogenicity of GC FLU compared to active control in terms of HAI titers against each virus strain at 21 days after the vaccination.
Time Frame
21 days after the vaccination
Title
The Seroconversion Rate
Description
The non-inferior immunogenicity of GC FLU compared to active control in terms of HAI titers against each virus strain at 21 days after the vaccination.
Time Frame
21 days after the vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Provision of signed and dated informed consent form
Either gender, aged 20 to 50 years old (inclusive)
Willing and able to comply with all the required study visits and follow-up defined by this protocol
Female subject with childbearing potential or male subject with female spouse/partner with childbearing potential must agree to use highly effective contraceptives from 15 days prior to vaccination until 60 days after vaccination. At least two forms of birth control must be adopted and one of which must be a barrier method. Acceptable forms include:
Established use of oral, injected or implanted hormonal methods of contraception
Placement of an intrauterine device (IUD) or intrauterine system (IUS)
Barrier methods of contraception: condom, or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
Exclusion Criteria:
With previous known or potential exposure to influenza virus within 12 weeks prior to vaccination
Received seasonal influenza vaccine (registered or investigational) within 24 weeks prior to vaccination
Received any vaccine other than seasonal influenza vaccine within 6 weeks prior to vaccination
Received other investigational products (including medications and vaccines) within 6 weeks prior to vaccination
Administered immunoglobulins and/or other blood products within the 12 weeks prior to vaccination
Known or suspected hypersensitivity to any component of vaccines (including egg proteins); or history of allergy to consumption of eggs
History of inflammatory or degenerative neurological disease (e.g., Guillain-Barre syndrome)
With confirmed or suspected immunosuppressive or immunodeficient condition (e.g. HIV infection), or received > 14 days of systemic steroid with equivalent dosage equal or over to 0.5 mg/kg/day prednisolone or other immune-modifying agents within 24 weeks prior to vaccination
Positive in HIV, HBsAg, or HCV test
With fever (defined as body temperature equal or over to 38 °C by any method) on the day of vaccination
With ongoing acute diseases or within the past 2 years serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the subject
Female subject who is lactating or has positive serum or urine pregnancy test at screening or vaccination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Szu-Min Hsieh, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Municipal Wan Fang Hospital
City
Taipei
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine
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