Randomized Influenza Vaccine Evaluation of Immune Response

Phase 4

Active, not recruiting

• Conditions: Influenza

• Registration Number: NCT03598439
• Lead Sponsor: Marshfield Clinic Research Foundation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-26
• Study Start: 2018-07-30
• Primary Completion: 2020-03-18
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-24
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 366

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post-vaccination titer	28 days	geometric mean titers (as measured by microneutralization) to cell-grown A(H3N2) vaccine reference virus

Trial Locations

Locations (1)

Marshfield Clinic - Marshfield Center; 🇺🇸 Marshfield, Wisconsin, United States