Randomized Influenza Vaccine Evaluation of Immune Response

NCT03598439 | Completed Phase 4 FDA Drug

• 1 other identifier: MCL10218
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

influenza vaccine; adults; Immune response

Outcome Measures

Primary Outcomes (1)

• Post-vaccination titer

  geometric mean titers (as measured by microneutralization) to cell-grown A(H3N2) vaccine reference virus

  28 days

Study Arms (3)

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.

Biological: Recombinant

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

Biological: Cell-culture

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.

Biological: Standard IIV4

Interventions

Standard IIV4 BIOLOGICAL

Standard inactivated influenza vaccine

Also known as: Flulaval Quadrivalent

Standard (IIV4) Influenza Vaccine

Recombinant BIOLOGICAL

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

Also known as: FluBlok Quadrivalent

Recombinant (RIV4) Influenza Vaccine

Cell-culture BIOLOGICAL

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

Also known as: Flucelvax Quadrivalent

Cell-culture (ccIIV4) Influenza Vaccine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Marshfield Clinic Research Foundation: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Cell Culture Techniques

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Culture Techniques; In Vitro Techniques

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Study Start: July 30, 2018
• Primary Completion: March 18, 2020
• Study Completion: July 9, 2024
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)