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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
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This is a randomized, observer-blinded, placebo-controlled trial in adults 18 to 64 years old. Randomization will be stratified by age (18 to 49 years and 50 to 64 years) and by prior influenza immunization within the past three months. Subjects 18 to 49 years of age will comprise ~67% of subjects in each treatment group, and the balance will comprise subjects 50 to 64 years.
Each subject will receive two identical IM doses of test article at a 21-day interval (Day 0 and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately 385 days total, or approximately 13 months from the first dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Placebo |
|
| Group B | Experimental | High dose Monovalent Avian Influenza VLP (H7N9); IM; Day 0 and Day 21 |
|
| Group C | Experimental | High dose Monovalent Avian Influenza VLP (H7N9) with Low dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21 |
|
| Group D | Experimental | Intermediate dose Monovalent Avian Influenza VLP (H7N9) with Low dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21 |
|
| Group E | Experimental | Low dose Monovalent Avian Influenza VLP (H7N9) with Low dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21 |
|
| Group F |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monovalent Avian Influenza VLP (H7N9) | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Safety | Counts (and percentages) of subjects with solicited local and systemic AEs over the seven days post-injection and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 42 days post-first injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year. | Day 0 to Day 384 |
| Immunogenicity as assessed by hemagglutination-inhibiting (HAI) antibody titers against the vaccine-homologous A/Anhui/1/13 (H7N9) virus. | Geometric mean titer (GMT) Geometric mean ratio (GMR) Seroconversion rate (SCR) Seroresponse rate (SRR) | Day 0 to Day 384 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity as assessed by neuraminidase-inhibiting antibodies to N9. | Day 0 to Day 384 |
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Inclusion Criteria:
Exclusion Criteria:
Subjects will be excluded if they meet any of the following criteria:
Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.
Any grade 1 or higher (as based on the Toxicity Grading Scale [TGS]) abnormality in ALT, AST, alkaline phosphatase, total bilirubin, blood urea nitrogen, or creatinine levels.
Any grade 2 or higher (as based on the TGS) vital sign or clinical laboratory abnormality not specified in criterion 2 above. Note that any abnormal vital sign may be repeated at the Investigator's discretion.
Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
History of a serious reaction to prior influenza vaccination.
History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
Received any vaccine in the 4 weeks preceding the study vaccination; or any A(H7N9) avian influenza vaccine at any time.
Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature >38.0°C on the planned day of vaccine administration).
Known disturbance of coagulation.
Women who are pregnant or breastfeeding, or plan to become pregnant during the study.
Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
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| Name | Affiliation | Role |
|---|---|---|
| D. Nigel Thomas, Ph. D. | Novavax, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States | ||
| Miami Research Associates |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Experimental |
High dose Monovalent Avian Influenza VLP (H7N9) with High dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21 |
|
| Group G | Experimental | Intermediate dose Monovalent Avian Influenza VLP (H7N9) with High dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21 |
|
| Group H | Experimental | Low dose Monovalent Avian Influenza VLP (H7N9) with High dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21 |
|
| Matrix-M1™ adjuvant | Biological |
|
| Placebo | Biological |
|
| Miami |
| Florida |
| 33143 |
| United States |
| Advanced Clinical Research | Meridian | Idaho | 83642 | United States |
| Regional Clinical Research, Inc. | Endwell | New York | 13760 | United States |
| Coastal Carolina Research | Mt. Pleasant | South Carolina | 29464 | United States |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |