Clinical Trials List
Protocol NumberCT-QV-31
NCT Number(ClinicalTrials.gov Identfier)NCT03718468
2018-10-15 - 2019-11-30
Phase III
Terminated4
ICD-10J09.X2
Influenza due to identified novel influenza A virus with other respiratory manifestations
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
-
Trial Applicant
Medigen Vaccine Biologics corp.
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Sponsor
Medigen Vaccine Biologics Corp.
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Trial scale
Taiwan Multiple Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Tsong-Yih Ou Division of Infectious Disease
- Fu-Lun Chen Division of Infectious Disease
The Actual Total Number of Participants Enrolled
162 Stop recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Jau-Yuan Chen Division of Family Medicine
- 林彥安 Division of Family Medicine
- 方薇青 Division of Family Medicine
- 李雨蒨 Division of Family Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
Influenza
Objectives
Primary
Demonstrate the immunological noninferiority of GC FLU compared to active control in terms of either geometric mean titer
(GMT) treatment ratio or seroconversion rate (SCR) treatment difference of hemagglutination inhibiting (HAI) antibody against 4 virus strains
Secondary
Evaluate the immunogenicity of GC FLU in terms of seroconversion rate (SCR), seroprotection rate (SPR) and geometric mean titer increase (GMI) as well as describe the safety profile of GC FLU
Test Drug
GCFLU Quadrivalent Pre-filled Syringe inj.
Active Ingredient
A/Singapore/GP1908/2015 IVR-180(H1N1)血凝素(Haemagglutinin)抗原
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2)血凝素(Haemagglutinin)抗原
B/Maryland/15/2016 NYMC BX-69A 血凝素(Haemagglutinin)抗原
B/Phuket/3073/2013 血凝素(Haemagglutinin)抗原
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2)血凝素(Haemagglutinin)抗原
B/Maryland/15/2016 NYMC BX-69A 血凝素(Haemagglutinin)抗原
B/Phuket/3073/2013 血凝素(Haemagglutinin)抗原
Dosage Form
Dosage
15
15
15
15
15
15
15
Endpoints
Multiple Primary Endpoints:
Two multiple primary endpoints are set for this study:
1. The non-inferior immunogenicity of GC FLU compared to active
control in terms of HAI titers against each virus strain on Day 22:
The ratio of the geographic mean titers (GMT)
(GMTAC/GMTGCFLU) ≤ 1.5
2. The non-inferior immunogenicity of GC FLU compared to active
control in terms of HAI titers against each virus strain on Day 22:
The difference between the seroconversion rates (SCRAC −
SCRGCFLU) ≤ 10%
Note: seroconversion rate (SCR) is defined as the percentage of
subjects with a serum HAI titer 1:40 (if pre-vaccination titer <
1:10) or 4-folds increase (if pre-vaccination titer 1:10) on Day
22
Secondary Endpoints:
1. The percentage of subjects achieving seroconversion (SCR) on Day
22
2. The percentage of subjects on Day 22 achieving an HAI antibody
titer ≥ 1:40 (seroprotection rate, SPR)
3. Geometric mean titer increase (GMI), defined as the fold increase
on Day 22 compared to baseline (GMTD22/GMTbaseline)
4. The incidence, severity, and relationship of solicited adverse
events, unsolicited adverse events, severe/potential life-threatening
adverse events, and serious adverse events
Solicited adverse events are defined as the adverse events listed
below that occurred after vaccination until Day 8:
- Local reactions: pain, tenderness, erythema/redness, and
induration/swelling
- Systemic reactions: fever, sweating, chills, nausea/vomiting,
diarrhea, fatigue/malaise, headache, myalgia, and arthralgia
Unsolicited adverse events are defined as all adverse events not
belonging to solicited adverse events after vaccination until Day 22
Two multiple primary endpoints are set for this study:
1. The non-inferior immunogenicity of GC FLU compared to active
control in terms of HAI titers against each virus strain on Day 22:
The ratio of the geographic mean titers (GMT)
(GMTAC/GMTGCFLU) ≤ 1.5
2. The non-inferior immunogenicity of GC FLU compared to active
control in terms of HAI titers against each virus strain on Day 22:
The difference between the seroconversion rates (SCRAC −
SCRGCFLU) ≤ 10%
Note: seroconversion rate (SCR) is defined as the percentage of
subjects with a serum HAI titer 1:40 (if pre-vaccination titer <
1:10) or 4-folds increase (if pre-vaccination titer 1:10) on Day
22
Secondary Endpoints:
1. The percentage of subjects achieving seroconversion (SCR) on Day
22
2. The percentage of subjects on Day 22 achieving an HAI antibody
titer ≥ 1:40 (seroprotection rate, SPR)
3. Geometric mean titer increase (GMI), defined as the fold increase
on Day 22 compared to baseline (GMTD22/GMTbaseline)
4. The incidence, severity, and relationship of solicited adverse
events, unsolicited adverse events, severe/potential life-threatening
adverse events, and serious adverse events
Solicited adverse events are defined as the adverse events listed
below that occurred after vaccination until Day 8:
- Local reactions: pain, tenderness, erythema/redness, and
induration/swelling
- Systemic reactions: fever, sweating, chills, nausea/vomiting,
diarrhea, fatigue/malaise, headache, myalgia, and arthralgia
Unsolicited adverse events are defined as all adverse events not
belonging to solicited adverse events after vaccination until Day 22
Inclution Criteria
INCLUSION CRITERIA
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. Provision of signed and dated informed consent form
2. Either gender, aged 20 to 50 years old (inclusive)
3. Willing and able to comply with all the required study visits and follow-up defined by this
protocol
4. 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
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. Provision of signed and dated informed consent form
2. Either gender, aged 20 to 50 years old (inclusive)
3. Willing and able to comply with all the required study visits and follow-up defined by this
protocol
4. 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
EXCLUSION CRITERIA
Any subject meeting any of the exclusion criteria will be excluded from study participation:
1. With previous known or potential exposure to influenza virus within 12 weeks prior to
vaccination
2. Received seasonal influenza vaccine (registered or investigational) within 24 weeks prior to
vaccination
3. Received any vaccine other than seasonal influenza vaccine within 6 weeks prior to
vaccination
4. Received other investigational products (including medications and vaccines) within 6
weeks prior to vaccination
5. Administered immunoglobulins and/or other blood products within the 12 weeks prior to
vaccination
6. Known or suspected hypersensitivity to any component of vaccines (including egg proteins);
or history of allergy to consumption of eggs
7. History of inflammatory or degenerative neurological disease (e.g., Guillain-Barre syndrome)
8. With confirmed or suspected immunosuppressive or immunodeficient condition (e.g. HIV
infection), or received > 14 days of systemic steroid with equivalent dosage 0.5 mg/kg/day
prednisolone or other immune-modifying agents within 24 weeks prior to vaccination
9. Positive in HIV, HBsAg, or HCV test
10. With fever (defined as body temperature 38 °C by any method) on the day of vaccination
11. 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
12. Female subject who is lactating or has positive serum or urine pregnancy test at screening or
vaccination
Any subject meeting any of the exclusion criteria will be excluded from study participation:
1. With previous known or potential exposure to influenza virus within 12 weeks prior to
vaccination
2. Received seasonal influenza vaccine (registered or investigational) within 24 weeks prior to
vaccination
3. Received any vaccine other than seasonal influenza vaccine within 6 weeks prior to
vaccination
4. Received other investigational products (including medications and vaccines) within 6
weeks prior to vaccination
5. Administered immunoglobulins and/or other blood products within the 12 weeks prior to
vaccination
6. Known or suspected hypersensitivity to any component of vaccines (including egg proteins);
or history of allergy to consumption of eggs
7. History of inflammatory or degenerative neurological disease (e.g., Guillain-Barre syndrome)
8. With confirmed or suspected immunosuppressive or immunodeficient condition (e.g. HIV
infection), or received > 14 days of systemic steroid with equivalent dosage 0.5 mg/kg/day
prednisolone or other immune-modifying agents within 24 weeks prior to vaccination
9. Positive in HIV, HBsAg, or HCV test
10. With fever (defined as body temperature 38 °C by any method) on the day of vaccination
11. 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
12. Female subject who is lactating or has positive serum or urine pregnancy test at screening or
vaccination
The Estimated Number of Participants
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Taiwan
840 participants
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Global
840 participants
