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Inactivated Vaccine

Egg-based vs. Non-egg-based Flu Vaccines for Influenza (RIVER Trial)

Phase 4
Waitlist Available
Research Sponsored by Marshfield Clinic Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the effectiveness of two types of influenza vaccines - those made using eggs, and those that don't - in adults. The goal is to see if there are any differences in the body's immune response to the two types of vaccines.

Who is the study for?
This trial is for adults aged 18-64 who are patients at the Marshfield Clinic in Wisconsin and have been living there since July 2015. Participants must be able to consent and follow study rules. Pregnant individuals, those already vaccinated for flu this season, or involved in another clinical trial with an experimental agent cannot join.
What is being tested?
The study compares immune responses to two types of flu vaccines: one grown in eggs (Standard IIV4) and two not grown in eggs (Flucelvax from cell culture & FluBlok recombinant). It aims to see if non-egg-based vaccines produce a better immune response over two flu seasons.
What are the potential side effects?
Common side effects of influenza vaccines include soreness at the injection site, headache, fever, nausea, muscle aches. Rarely they can cause allergic reactions or more serious issues like difficulty breathing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Post-vaccination titer

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Recombinant (RIV4) Influenza VaccineExperimental Treatment1 Intervention
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 II: Cell-culture (ccIIV4) Influenza VaccineExperimental Treatment1 Intervention
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 III: Standard (IIV4) Influenza VaccineActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Centers for Disease Control and PreventionFED
887 Previous Clinical Trials
21,996,227 Total Patients Enrolled
Marshfield Clinic Research FoundationLead Sponsor
14 Previous Clinical Trials
9,850 Total Patients Enrolled

Media Library

Cell-culture (Inactivated Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03598439 — Phase 4
Influenza Research Study Groups: Recombinant (RIV4) Influenza Vaccine, Cell-culture (ccIIV4) Influenza Vaccine, Standard (IIV4) Influenza Vaccine
Influenza Clinical Trial 2023: Cell-culture Highlights & Side Effects. Trial Name: NCT03598439 — Phase 4
Cell-culture (Inactivated Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03598439 — Phase 4
~50 spots leftby Nov 2025
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