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This study aims to evaluate the safety and immunogenicity of an inactivated cell culture derived H7N9 vaccine in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AT-501 High Dose vaccine | Experimental | Inactivated H7N9 High Dose Antigen |
|
| AT-501 High Dose vaccine with Adjuvant | Experimental | Inactivated H7N9 High Dose Antigen with Adjuvant |
|
| AT-501 Low Dose vaccine | Experimental | Inactivated H7N9 Low Dose Antigen |
|
| AT-501 Low Dose vaccine with Adjuvant | Experimental | Inactivated H7N9 Low Dose Antigen with Adjuvant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AT-501 High Dose vaccine | Biological | Comparison of each dose of vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of AT-501 vaccine measured by Adverse Event | Phase 1
| 1 year from the start of study enrolment |
| Immunogenicity of AT-501 vaccine measured by HI titers | Phase 2 HI titers as follows:
| 1 year from the start of study enrolment |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of AT-501 vaccine measured HI and neutralizing antibody titers | Phase 1
| 1 year from the start of study enrolment |
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Inclusion Criteria:
Subject within the age limit range, is free of obvious health problems as judged by the investigator before entering the study.
Female subjects must be:
Subject is willing and able to comply with all required study visits and follow-up required by this protocol.
Subject must provide written informed consent or the Subjects' legal representative must understand and consent to the procedure.
Exclusion Criteria:
Subjects with previous known or potential exposure to avian influenza virus H7N9 HA antigen and any other avian influenza including H5N1.
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
Subjects administered with any other vaccine during the period within 6 weeks before the first administration of study vaccine.
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.
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.
Subjects with a history of inflammatory or degenerative neurological disease .
Subjects receiving chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. Inhaled and topical steroids are allowed.
Known HIV, hepatitis B (HBsAg) or hepatitis C seropositivity.
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.
The subjects would not be suitable for the vaccination if the screening laboratory tests show any of the follows
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.
Subjects with acute disease at the time of enrolment.
Use of any investigational or non-registered product 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.
Psychiatric, addictive, or any disorder, which may compromise the ability to give a truly informed consent for participation of this study or adequate compliance.
Any clinically relevant disease and/or abnormal laboratory findings (, 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.
Breast feeding or pregnant women or refusal to submit to a urine test to rule out pregnancy prior to enrolment and during the study.
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| Name | Affiliation | Role |
|---|---|---|
| Shan-Chwen Chang, Dr. | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28668573 | Derived | Wu UI, Hsieh SM, Lee WS, Wang NC, Kung HC, Ou TY, Chen FL, Lin TY, Chen YC, Chang SC. Safety and immunogenicity of an inactivated cell culture-derived H7N9 influenza vaccine in healthy adults: A phase I/II, prospective, randomized, open-label trial. Vaccine. 2017 Jul 24;35(33):4099-4104. doi: 10.1016/j.vaccine.2017.06.044. Epub 2017 Jun 28. |
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| AT-501 High Dose vaccine with Adjuvant |
| Biological |
Comparison of each dose of vaccine |
|
| AT-501 Low Dose vaccine | Biological | Comparison of each dose of vaccine |
|
| AT-501 Low Dose vaccine with Adjuvant | Biological | Comparison of each dose of vaccine |
|
| Safety of AT-501 vaccine measured by Adverse Event |
Phase 2
|
| 1 year from the start of study enrolment |
| ID | Term |
|---|---|
| D014612 | Vaccines |
| D000277 | Adjuvants, Pharmaceutic |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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