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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
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The purpose of this study is to determine the immune response of three dose levels of the Novavax Quadrivalent vaccine in healthy young adults (18-64). The study is broken down into 5 treatment groups. Each group will enroll 100 subjects, for a total of 500 subjects. Group 1-3 will receive one of three dose levels of the Novavax Quadrivalent vaccine, Group 4 will receive a dose of the Novavax Trivalent vaccine, and Group 5 will receive a commercially available trivalent influenza vaccine (TIV). The study will also evaluate the safety and tolerability of the Novavax Quadrivalent vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
| |
| Group 2 | Experimental |
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| Group 3 | Experimental |
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| Group 4 | Experimental |
| |
| Group 5 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novavax Quadrivalent vaccine | Biological | Quadrivalent VLP vaccine: low dose; intramuscular injection, deltoid |
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| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of 3 dose levels of the Novavax Quadrivalent vaccine based on HAI responses | Day 21 | |
| Number of Solicited and Unsolicited Adverse Events for the Novavax Quadrivalent vaccine | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate capacity of the Novavax Quadrivalent vaccines to fulfill FDA criteria (immunogenicity) for all strains in healthy, young adults | Based on criteria of greater than or equal to 40% HAI seroconversion and greater than or equal to 70% of subjects with HAI titers greater than or equal to 1:40 post-vaccination. | Day 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nigel Thomas, Ph.D. | Novavax | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX | Adelaide | Australia | ||||
| Emeritus Research |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Novavax Quadrivalent vaccine | Biological | Quadrivalent VLP vaccine: medium dose; intramuscular injection, deltoid |
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| Novavax Quadrivalent vaccine | Biological | Quadrivalent VLP vaccine: high dose; intramuscular injection, deltoid |
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| Novavax Trivalent vaccine | Biological | Trivalent Dose; intramuscular injection, deltoid |
|
| cTIV | Biological | Preconfigured dose; intramuscular injection, deltoid |
|
| Impact of including a fourth strain in the Novavax Quadrivalent vaccine on immune responses to other three strains |
Based on comparison to a trivalent NovaFlu formulation tested at the 22.5ug of HA (per strain) dose level. |
| Day 21 |
| Melbourne |
| Australia |
| Linear Clinical Research | Perth | Australia |
| Holdsworth House | Sydney | Australia |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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