Randomized Influenza Vaccine Evaluation of Immune Response

Completed · Phase 4

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT03598439

Run by

Marshfield Clinic Research Foundation

People needed

366

Starts

2018-07-30

Expected to finish

2024-07-09

Last updated by the study team

2025-11-21

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Marshfield Clinic - Marshfield Center — Marshfield, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.