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Randomized Influenza Vaccine Evaluation of Immune Response (RIVER)

Primary Purpose

Influenza

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Standard IIV4
Recombinant
Cell-culture
Sponsored by
Marshfield Clinic Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Influenza focused on measuring influenza vaccine, adults, Immune response

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Marshfield Clinic - Marshfield Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Recombinant (RIV4) Influenza Vaccine

Cell-culture (ccIIV4) Influenza Vaccine

Standard (IIV4) Influenza Vaccine

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 16, 2018
Last Updated
April 21, 2023
Sponsor
Marshfield Clinic Research Foundation
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT03598439
Brief Title
Randomized Influenza Vaccine Evaluation of Immune Response
Acronym
RIVER
Official Title
Randomized Open-Label Trial to Compare Immunogenicity of Egg-Based and Non-Egg Based Quadrivalent Influenza Vaccines Among Adults 18-64 Years of Age (US Flu Vaccine Effectiveness Serologic Study, 2018-19 and 2019-20)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 30, 2018 (Actual)
Primary Completion Date
March 18, 2020 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marshfield Clinic Research Foundation
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza vaccine, adults, Immune response

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
366 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recombinant (RIV4) Influenza Vaccine
Arm Type
Experimental
Arm Description
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.
Arm Title
Cell-culture (ccIIV4) Influenza Vaccine
Arm Type
Experimental
Arm Description
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
Arm Title
Standard (IIV4) Influenza Vaccine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Standard IIV4
Other Intervention Name(s)
Flulaval Quadrivalent
Intervention Description
Standard inactivated influenza vaccine
Intervention Type
Biological
Intervention Name(s)
Recombinant
Other Intervention Name(s)
FluBlok Quadrivalent
Intervention Description
Influenza vaccine that uses a hemagglutinin protein manufactured in insect cells with a baculovirus vector
Intervention Type
Biological
Intervention Name(s)
Cell-culture
Other Intervention Name(s)
Flucelvax Quadrivalent
Intervention Description
inactivated influenza vaccine manufactured using mammalian cell lines; current vaccine uses a cell-propagated H3N2 strain.
Primary Outcome Measure Information:
Title
Post-vaccination titer
Description
geometric mean titers (as measured by microneutralization) to cell-grown A(H3N2) vaccine reference virus
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Marshfield Clinic - Marshfield Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Randomized Influenza Vaccine Evaluation of Immune Response

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