Clinical Trials List
Protocol NumberCT-MV-21
NCT Number(ClinicalTrials.gov Identfier)NCT02436928
2015-04-01 - 2016-06-30
Phase I/II
Terminated3
ICD-10T50.B95D
Adverse effect of other viral vaccines, subsequent encounter
A Phase I/II, Prospective, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of an Inactivated Cell Culture Derived H7N9 Influenza Vaccine in Healthy Adult Subjects
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Trial Applicant
Medigen Vaccine Biologics corp.
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Sponsor
Medigen Vaccine Biologics Corp.
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 林德宇 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Tsong-Yih Ou Division of Infectious Disease
- Fu-Lun Chen Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Un-in Wu Division of Infectious Disease
- 劉志猷 Division of Infectious Disease
- 張崧溪 Division of Infectious Disease
- Szu-Min Hsieh Division of Infectious Disease
- 周郁茹 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
H7N9 Influenza Vaccine
Objectives
Primary:
Phase I
Safety
To evaluate the safety of AT-501 vaccine, in two different strength (15 mcg HA and
30 mcg HA with or without aluminum hydroxide adjuvant)
Phase II
Immunogenicity
To evaluate the changes in serum HI titers elicited by AT-501 vaccine, in two
different strength (15 mcg HA and 30 mcg HA with or without aluminum hydroxide
adjuvant), according to the current CHMP requirements (CPMP/BWP214/96) 21
days after the first and second vaccination in healthy adult population
Secondary:
Phase I
Immunogenicity
To evaluate the changes in serum HI titers and neutralizing antibody titers elicited by
AT-501 vaccine (15 mcg HA and 30 mcg HA with or without aluminium hydroxide
adjuvant).
Phase II
Immunogenicity
To evaluate the changes in neutralizing antibody titers elicited by AT-501 vaccine (15
mcg HA and 30 mcg HA with or without aluminium hydroxide adjuvant).
Safety
To evaluate the safety of AT-501 vaccine, in two different strength (15 mcg HA and
30 mcg HA with or without aluminium hydroxide adjuvant)
Test Drug
AT-501
Active Ingredient
H7N9 hemagglutinin antigen (HA)
Dosage Form
Injection
Dosage
0.5 ml contain 15 or 30 mg HA
Endpoints
Primary:
Phase I
Safety
• Percentage, intensity and relationship to vaccination of solicited local and
general signs and symptoms during a 7-day follow-up period (i.e. day of
vaccination and 6 subsequent days) after the first and second dose of
administered vaccine.
• Percentage, intensity and relationship to vaccination of unsolicited local and
general signs and symptoms during a 21-day follow-up period (i.e. day of
vaccination and 20 subsequent days) after each administered vaccine.
• Occurrence of overall adverse events and serious adverse events during the
entire period of study.
Phase II:
Immunogenicity:
Derived variables: in terms of HI titers tested by haemagglutination-inhibition
assay as follows:
- Seroconversion Rate (SCR) at day 22 and 43
- Seroconversion Factor (SCF) at day 22 and day 43
- Seroprotection Rate (SPR) at day 22 and day 43
Secondary:
Phase I:
Immunogenicity
• Observed variables: Change of antibody titers from baseline to day 22 and
day 43, of both serum HI titers tested by haemagglutination-inhibition assay
and serum neutralizing antibody titers tested by neutralization assay
• Derived variables: Geometric Mean Titer (GMT) of both serum HI titers and
neutralizing antibody titers, pre-vaccination and day 22 and day 43 postvaccination
Phase II:
Immunogenicity
• Observed variables: Change of antibody titers from baseline to day 22 and
day 43, of serum neutralizing antibody titers tested by neutralization assay
• Derived variables: Geometric Mean Titer (GMT) of serum neutralizing
antibody titers, pre-vaccination and day 22 and day 43 post-vaccination
Safety
• Percentage, intensity and relationship to vaccination of solicited local and
general signs and symptoms during a 7-day follow-up period (i.e. day of
vaccination and 6 subsequent days) after the first and second dose of
administered vaccine.
• Percentage, intensity and relationship to vaccination of unsolicited local and
general signs and symptoms during a 21-day follow-up period (i.e. day of
vaccination and 20 subsequent days) after each administered vaccine.
• Occurrence of overall adverse events and serious adverse events during the
entire period of study.
Phase I
Safety
• Percentage, intensity and relationship to vaccination of solicited local and
general signs and symptoms during a 7-day follow-up period (i.e. day of
vaccination and 6 subsequent days) after the first and second dose of
administered vaccine.
• Percentage, intensity and relationship to vaccination of unsolicited local and
general signs and symptoms during a 21-day follow-up period (i.e. day of
vaccination and 20 subsequent days) after each administered vaccine.
• Occurrence of overall adverse events and serious adverse events during the
entire period of study.
Phase II:
Immunogenicity:
Derived variables: in terms of HI titers tested by haemagglutination-inhibition
assay as follows:
- Seroconversion Rate (SCR) at day 22 and 43
- Seroconversion Factor (SCF) at day 22 and day 43
- Seroprotection Rate (SPR) at day 22 and day 43
Secondary:
Phase I:
Immunogenicity
• Observed variables: Change of antibody titers from baseline to day 22 and
day 43, of both serum HI titers tested by haemagglutination-inhibition assay
and serum neutralizing antibody titers tested by neutralization assay
• Derived variables: Geometric Mean Titer (GMT) of both serum HI titers and
neutralizing antibody titers, pre-vaccination and day 22 and day 43 postvaccination
Phase II:
Immunogenicity
• Observed variables: Change of antibody titers from baseline to day 22 and
day 43, of serum neutralizing antibody titers tested by neutralization assay
• Derived variables: Geometric Mean Titer (GMT) of serum neutralizing
antibody titers, pre-vaccination and day 22 and day 43 post-vaccination
Safety
• Percentage, intensity and relationship to vaccination of solicited local and
general signs and symptoms during a 7-day follow-up period (i.e. day of
vaccination and 6 subsequent days) after the first and second dose of
administered vaccine.
• Percentage, intensity and relationship to vaccination of unsolicited local and
general signs and symptoms during a 21-day follow-up period (i.e. day of
vaccination and 20 subsequent days) after each administered vaccine.
• Occurrence of overall adverse events and serious adverse events during the
entire period of study.
Inclution Criteria
1. Male or female healthy volunteer ≥20 and < 60 years of age.
2. Subject free of obvious health problems as judged by the investigator (established by medical
history, physical examination and laboratory screening tests) before entering the study.
3. Female subjects must be:
- either of non-childbearing potential, i.e. surgically sterilized (defined as having undergone
hysterectomy and/or bilateral oophrectomy and/or bilateral salpingectomy; tubal ligation alone
is not considered sufficient) or one year post-menopausal;
- or, if of childbearing potential, must be abstinent or have used adequate contraceptive
precautions, (i.e., intrauterine contraceptive device; oral contraceptives; diaphragm or condom
in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera® ) for 30
days prior to receiving the study vaccination, have a negative pregnancy test and must agree to
continue such precautions for two months after completion of the vaccination series.
4. Subject is willing and able to comply with all required study visits and follow-up required by this
protocol.
5. Subject must provide written informed consent or the Subjects’ legal representative must
understand and consent to the procedure
2. Subject free of obvious health problems as judged by the investigator (established by medical
history, physical examination and laboratory screening tests) before entering the study.
3. Female subjects must be:
- either of non-childbearing potential, i.e. surgically sterilized (defined as having undergone
hysterectomy and/or bilateral oophrectomy and/or bilateral salpingectomy; tubal ligation alone
is not considered sufficient) or one year post-menopausal;
- or, if of childbearing potential, must be abstinent or have used adequate contraceptive
precautions, (i.e., intrauterine contraceptive device; oral contraceptives; diaphragm or condom
in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera® ) for 30
days prior to receiving the study vaccination, have a negative pregnancy test and must agree to
continue such precautions for two months after completion of the vaccination series.
4. Subject is willing and able to comply with all required study visits and follow-up required by this
protocol.
5. Subject must provide written informed consent or the Subjects’ legal representative must
understand and consent to the procedure
Exclusion Criteria
1. Subjects with previous known or potential exposure to avian influenza virus H7N9 HA antigen and
any other avian influenza including H5N1.
2. Subjects who have had seasonal influenza vaccine within 6 months prior to enrolment or who will
have seasonal influenza vaccine at any time during the study period.
3. Subjects administered with any other vaccine during the period within 6 weeks before the first
administration of study vaccine.
4. Subjects with confirmed or suspected abnormal immune function, immunosuppressive or
immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on
medical history and physical examination.
5. Subjects with a history of hypersensitivity to vaccines or a history of allergic disease or reactions
likely to be exacerbated by any component of the vaccine.
6. Subjects with a history of inflammatory or degenerative neurological disease (e.g., Guillain Barre
Syndrome).
7. Subjects receiving chronic administration (defined as more than 14 days) of immunosuppressants
or other immune-modifying drugs within 6 months prior to the administration of the study vaccine.
(NOTE*: for corticosteroids, this includes prednisone or equivalent, 0.5 mg/kg/day). Inhaled and
topical steroids are allowed.
8. Known HIV, hepatitis B (HBsAg) or hepatitis C seropositivity.
9. Subjects, judged by the investigator, with any clinically significant medical illness including acute
pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical
history, physical examination and/or laboratory screening tests.
10. The subjects would not be suitable for the vaccination if the screening laboratory tests show any of
the follows:
‐ ALT or AST > upper limit of normal range (ULN);
‐ Serum creatinine > upper limit of normal range (ULN);
‐ Any significant laboratory abnormality as judged by the investigator.
11. Subjects receiving administration of immunoglobulins and/or any blood products within the 3
months preceding the administration of the study vaccine or at any time during the study
12. Subjects with acute disease at the time of enrolment (defined as presence of moderate or severe
illness with or without fever (tympanic temperature ≥38℃)
13. Use of any investigational or non-registered product (including drug and vaccine) other than the
study vaccine within 30 days prior to the first vaccination, or planned use of the abovementioned
product during the entire study period.
14. Psychiatric, addictive, or any disorder, which may compromise the ability to give a truly informed
consent for participation of this study or adequate compliance.
15. Any clinically relevant disease and/or abnormal laboratory findings (past or present), which, in the
opinion of the Investigator, may either put the patient at risk because of participation in the study,
or influence the results of the study, or the patient’s ability to participate in the study.
16. Breast feeding or pregnant women or refusal to submit to a urine test to rule out pregnancy prior to
enrolment and during the study.
any other avian influenza including H5N1.
2. Subjects who have had seasonal influenza vaccine within 6 months prior to enrolment or who will
have seasonal influenza vaccine at any time during the study period.
3. Subjects administered with any other vaccine during the period within 6 weeks before the first
administration of study vaccine.
4. Subjects with confirmed or suspected abnormal immune function, immunosuppressive or
immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on
medical history and physical examination.
5. Subjects with a history of hypersensitivity to vaccines or a history of allergic disease or reactions
likely to be exacerbated by any component of the vaccine.
6. Subjects with a history of inflammatory or degenerative neurological disease (e.g., Guillain Barre
Syndrome).
7. Subjects receiving chronic administration (defined as more than 14 days) of immunosuppressants
or other immune-modifying drugs within 6 months prior to the administration of the study vaccine.
(NOTE*: for corticosteroids, this includes prednisone or equivalent, 0.5 mg/kg/day). Inhaled and
topical steroids are allowed.
8. Known HIV, hepatitis B (HBsAg) or hepatitis C seropositivity.
9. Subjects, judged by the investigator, with any clinically significant medical illness including acute
pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical
history, physical examination and/or laboratory screening tests.
10. The subjects would not be suitable for the vaccination if the screening laboratory tests show any of
the follows:
‐ ALT or AST > upper limit of normal range (ULN);
‐ Serum creatinine > upper limit of normal range (ULN);
‐ Any significant laboratory abnormality as judged by the investigator.
11. Subjects receiving administration of immunoglobulins and/or any blood products within the 3
months preceding the administration of the study vaccine or at any time during the study
12. Subjects with acute disease at the time of enrolment (defined as presence of moderate or severe
illness with or without fever (tympanic temperature ≥38℃)
13. Use of any investigational or non-registered product (including drug and vaccine) other than the
study vaccine within 30 days prior to the first vaccination, or planned use of the abovementioned
product during the entire study period.
14. Psychiatric, addictive, or any disorder, which may compromise the ability to give a truly informed
consent for participation of this study or adequate compliance.
15. Any clinically relevant disease and/or abnormal laboratory findings (past or present), which, in the
opinion of the Investigator, may either put the patient at risk because of participation in the study,
or influence the results of the study, or the patient’s ability to participate in the study.
16. Breast feeding or pregnant women or refusal to submit to a urine test to rule out pregnancy prior to
enrolment and during the study.
The Estimated Number of Participants
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Taiwan
200 participants
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Global
0 participants
