Randomized Influenza Vaccine Evaluation of Immune Response

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-30

Study Completion Date

2024-07-09

Brief Summary

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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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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Recombinant (RIV4) Influenza Vaccine

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.

Group Type EXPERIMENTAL

Recombinant

Intervention Type BIOLOGICAL

Influenza vaccine that uses a hemagglutinin protein manufactured in insect cells with a baculovirus vector

Cell-culture (ccIIV4) Influenza Vaccine

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

Group Type EXPERIMENTAL

Cell-culture

Intervention Type BIOLOGICAL

inactivated influenza vaccine manufactured using mammalian cell lines; current vaccine uses a cell-propagated H3N2 strain.

Standard (IIV4) Influenza Vaccine

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.

Group Type ACTIVE_COMPARATOR

Standard IIV4

Intervention Type BIOLOGICAL

Standard inactivated influenza vaccine

Interventions

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Standard IIV4

Standard inactivated influenza vaccine

Intervention Type BIOLOGICAL

Recombinant

Influenza vaccine that uses a hemagglutinin protein manufactured in insect cells with a baculovirus vector

Intervention Type BIOLOGICAL

Cell-culture

inactivated influenza vaccine manufactured using mammalian cell lines; current vaccine uses a cell-propagated H3N2 strain.

Intervention Type BIOLOGICAL

Other Intervention Names

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Flulaval Quadrivalent FluBlok Quadrivalent Flucelvax Quadrivalent

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No