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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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Licensed influenza vaccines are manufactured with a variety of technologies. The majority are split, inactivated vaccines derived from egg-adapted, high growth reassortant viruses. Two US licensed products do not use egg-adapted viruses: Flucelvax (mammalian cell culture) and FluBlok (recombinant). There is increasing evidence that egg propagation induces virus mutations that impair the immune responses to circulating viruses. However, the impact of egg-propagation on clinical vaccine effectiveness is uncertain, and there is no preferential recommendation for any specific influenza vaccine product or technology. A direct comparison of serologic response to egg based and non-egg based vaccines in adults has not been performed. This randomized trial will compare serologic responses to the egg- and non-egg A(H3N2) vaccine component. The study cohort will be followed for two influenza seasons to evaluate sequential vaccination effects on immune response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant (RIV4) Influenza Vaccine | Experimental | A single dose of licensed recombinant influenza vaccine will be given in each of two influenza seasons - one in 2018-19 and a second in 2019-20. |
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| Cell-culture (ccIIV4) Influenza Vaccine | Experimental | A single dose of licensed cell-culture influenza vaccine will be given in each of two influenza seasons - one in 2018-19 and a second in 2019-20 |
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| Standard (IIV4) Influenza Vaccine | Active Comparator | A single dose of licensed standard influenza vaccine will be given in each of two influenza seasons - one in 2018-19 and a second in 2019-20. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard IIV4 | Biological | Standard inactivated influenza vaccine |
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| Measure | Description | Time Frame |
|---|---|---|
| Post-vaccination titer | geometric mean titers (as measured by microneutralization) to cell-grown A(H3N2) vaccine reference virus | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | 54449 | United States |
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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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| ID | Term |
|---|---|
| D018929 | Cell Culture Techniques |
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Recombinant | Biological | Influenza vaccine that uses a hemagglutinin protein manufactured in insect cells with a baculovirus vector |
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| Cell-culture | Biological | inactivated influenza vaccine manufactured using mammalian cell lines; current vaccine uses a cell-propagated H3N2 strain. |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D008919 | Investigative Techniques |
| D046508 | Culture Techniques |
| D066298 | In Vitro Techniques |