Randomized Influenza Vaccine Evaluation of Immune Response
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 9/16/2018 |
| Start Date: | July 30, 2018 |
| End Date: | September 2020 |
Randomized Open-Label Trial to Compare Immunogenicity of Egg-Based and Non-Egg Based Quadrivalent Influenza Vaccines Among Adults 18-64 Years of Age (US Flu Vaccine Effectiveness Serologic Study, 2018-19 and 2019-20)
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.
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.
Inclusion Criteria:
- Aged 18-64 years
- Marshfield Clinic patients living in or around Marshfield, Wisconsin since July 2015
- Willing and able to give informed consent and comply with study requirements
Exclusion Criteria:
- Receipt of 2018-19 influenza vaccine prior to study enrollment
- Known to be pregnant at the time of enrollment
- Current participation or plans to participate in another clinical trial involving an
experimental agent
- Presence of a contraindication to influenza vaccination
- Plans to relocate outside the geographic location in the next two years
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Marshfield Clinic - Marshfield Center The Clinic was incorporated under Wisconsin law in 1916 and...
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