NCT04523324

Brief Summary

This randomized, open-label, active-controlled trial will assess humoral immune responses to a single dose of 2019-20 recombinant hemagglutinin quadrivalent influenza vaccines (RIV4) compared with standard egg-based unadjuvanted quadrivalent influenza vaccines (IIV4) among healthcare personnel (HCP) vaccinated during the previous 2018-19 season with IIV4. The trial will be conducted at two hospital sites in Israel during the 2019-20 influenza season among HCP who were enrolled in the Study of Healthcare Personnel with Influenza and other Respiratory Viruses in Israel (SHIRI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
577

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2019

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 15, 2023

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

August 19, 2020

Results QC Date

October 2, 2023

Last Update Submit

November 13, 2023

Conditions

Influenza

Keywords

InfluenzaHealthcare personnelImmunogenicityRepeat vaccination

Outcome Measures

Primary Outcomes (10)

  • Post-vaccination Geometric Mean Titer Against Influenza Virus A/H1N1

    The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for influenza virus A/H1N1

    Day 28 days after vaccination

  • Geometric Mean Titer Ratio (GMR) Against Influenza Virus A/H1N1

    The ratio of the pre- vs. post-vaccination titer against influenza virus A/H1N1 following a single dose of RIV4 versus IIV4.

    0 to 28 days after vaccination

  • Post-vaccination Geometric Mean Titer Against Egg-grown Influenza Virus A/H3N2

    The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for egg-grown influenza virus A/H3N2

    Day 28 days after vaccination

  • Geometric Mean Titer Ratio (GMR) Against Egg-grown Influenza Virus A/H3N2

    The ratio of the pre- vs. post-vaccination titer against egg-grown influenza virus A/H3N2 following a single dose of RIV4 versus IIV4.

    0 to 28 days after vaccination

  • Post-vaccination GMT Against Cell-grown Influenza Virus A/H3N2

    The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for cell-grown influenza virus A/H3N2

    Day 28 days after vaccination

  • Geometric Mean Titer Ratio (GMR) Against Cell-grown Influenza Virus A/H3N2

    The ratio of the pre- vs. post-vaccination titer against cell-grown influenza virus A/H3N2 following a single dose of RIV4 versus IIV4.

    0 to 28 days after vaccination

  • Post-vaccination Geometric Mean Titer Against Influenza B(Victoria)

    The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for Influenza B(Victoria)

    Day 28 days after vaccination

  • Geometric Mean Titer Ratio (GMR) Against Influenza B(Victoria)

    The ratio of the pre- vs. post-vaccination titer against Influenza B(Victoria) following a single dose of RIV4 versus IIV4.

    0 to 28 days after vaccination

  • Post-vaccination Geometric Mean Titer Against Influenza B(Yamagata)

    The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for Influenza B(Yamagata)

    Day 28 days after vaccination

  • Geometric Mean Titer Ratio (GMR) Against Influenza B(Yamagata)

    The ratio of the pre- vs. post-vaccination titer against Influenza B(Yamagata) following a single dose of RIV4 versus IIV4.

    0 to 28 days after vaccination

Study Arms (2)

RIV4 (Flublok Quadrivalent)

ACTIVE COMPARATOR

Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain

Biological: Flublok™ Quadrivalent by Sanofi, Inc.

IIV4 (Vaxigrip Quadrivalent)

ACTIVE COMPARATOR

VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based

Biological: VaxigripTetra™ by Sanofi, Inc.

Interventions

Flublok™ Quadrivalent by Sanofi, Inc.BIOLOGICAL

0.5 mL intramuscular dose of Flublok

RIV4 (Flublok Quadrivalent)
VaxigripTetra™ by Sanofi, Inc.BIOLOGICAL

0.5 mL intramuscular dose of Vaxigrip

IIV4 (Vaxigrip Quadrivalent)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged ≥18
  • Current member of Clalit Health Services
  • Consent to randomized receipt of influenza vaccination with either RIV4 or IIV4, or, if already vaccinated in the current year outside of the study, consent to receive a post-vaccination blood draw
  • Participated in the SHIRI study and received influenza vaccination during the 2018-19 influenza season (Group 1)
  • Participated in any year of the SHIRI study, not vaccinated in 2018-2019, but vaccinated in at least one study year (Group 1 supplemental)
  • Participated in the SHIRI study during all three years, regardless of vaccination status (Group 1 supplemental)
  • Participated in any year of the SHIRI study and had PCR-confirmed influenza virus infection during any of the three study years (Group 2)

You may not qualify if:

  • Already received an influenza vaccine during the current influenza season
  • Not willing or able to get the flu vaccines being used in this study;
  • Previous hypersensitivity reaction to the study vaccines, or any vaccine, as reported by the subject
  • Received any non-influenza vaccine (e.g., Hepatitis B or other vaccine recommended for HCP) in the 4 weeks prior to the first study visit or plans to receive a vaccine in the 4 weeks following the first study visit
  • Currently participating in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication), or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive an experimental agent during participation in this study.
  • Any condition or employment status that the potential participant or local study site principle investigator (PI) believes may interfere with successful completion of the study prior to December 2019, including being currently pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Soroka Medical Center

Beersheba, Israel

Location

Rabin Medical Center-Beilinson

Petah Tikva, Israel

Location

Related Publications (2)

  • Hirsch A, Katz MA, Laufer Peretz A, Greenberg D, Wendlandt R, Shemer Avni Y, Newes-Adeyi G, Gofer I, Leventer-Roberts M, Davidovitch N, Rosenthal A, Gur-Arie R, Hertz T, Glatman-Freedman A, Monto AS, Azziz-Baumgartner E, Ferdinands JM, Martin ET, Malosh RE, Neyra Quijandria JM, Levine M, Campbell W, Balicer R, Thompson MG; SHIRI workgroup. Study of Healthcare Personnel with Influenza and other Respiratory Viruses in Israel (SHIRI): study protocol. BMC Infect Dis. 2018 Nov 6;18(1):550. doi: 10.1186/s12879-018-3444-7.

    PMID: 30400834BACKGROUND

  • Fowlkes AL, Peretz A, Greenberg D, Hirsch A, Martin ET, Levine MZ, Edwards L, Radke S, Lauring AS, Ferdinands JM, Zhang C, Yoo YM, Dreiher J, Newes-Adeyi G, Azziz-Baumgartner E, Fry AM, Monto AS, Balicer R, Thompson MG, Katz MA. Randomised immunogenicity trial comparing 2019-2020 recombinant and egg-based influenza vaccines among frequently vaccinated healthcare personnel in Israel. Int J Infect Dis. 2024 Dec;149:107260. doi: 10.1016/j.ijid.2024.107260. Epub 2024 Oct 10.

    PMID: 39395753DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Dr. Ashley Fowlkes
Organization
Centers for Disease Control and Prevention
afowlkes@cdc.gov
4046394830

Study Officials

  • Mark G Thompson, PhD

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Open-label trial. Eligible HCP who report already having been vaccinated with Vaxigrip at the time they are approached to join the study will be eligible to participate.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2020

First Posted

August 21, 2020

Study Start

October 31, 2019

Primary Completion

January 30, 2020

Study Completion

August 30, 2022

Last Updated

November 15, 2023

Results First Posted

November 15, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

No current plans

Locations

IL(2)