NCT03331991

Brief Summary

The purpose of the study on the Prevention of Influenza and Other Wintertime Respiratory Viruses among Healthcare Professionals in Israel Effectiveness of Influenza Vaccine in Preventing Influenza Virus Infection, Missed Work, and Patient Exposure: A Prospective Cohort Study of Healthcare Personnel (to be called the Healthcare Personnel or HCP study throughout this Data Security Plan) is to investigate vaccine effectiveness and respiratory illness among healthcare personnel (HCP). This will help to better understand the factors that influence influenza vaccination choice, individual vaccine response, and whether or not the influenza vaccine helps to prevent influenza in HCP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

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

First Submitted

Initial submission to the registry

July 27, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 28, 2016

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 31, 2024

Status Verified

November 1, 2017

Enrollment Period

2.8 years

First QC Date

July 27, 2016

Last Update Submit

July 30, 2024

Conditions

Respiratory Tract DiseaseInfluenza

Outcome Measures

Primary Outcomes (2)

  • Frequency of acute respiratory illness among healthcare personnel receiving influenza vaccine

    3 years

  • Proportion of work days missed associated with self-reported acute respiratory illness

    3 years

Secondary Outcomes (2)

  • Frequency of asymptomatic and symptomatic infections (with typical or atypical symptom manifestations) with influenza viruses (and other viruses)

    3 years

  • Knowledge, attitudes, and practices (KAP) that predict vaccination hesitancy and refusal among healthcare personnel

    3 years

Interventions

influenza vaccineBIOLOGICAL

exposure to influenza vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthcare personnel

You may qualify if:

  • Be aged ≥18 years old;
  • Work at the facility full-time (≥30 hours per week);
  • Have routine direct hands-on or face-to-face contact with patients (within 1 meter) as part of a typical work shift, including, but not limited to, physicians, nurses, respiratory therapists, physical therapists, unit clerks, radiograph technicians, medical assistants, and transporters;
  • Continuous membership in Clalit Health plan for at least 1 year prior to enrollment.

You may not qualify if:

  • No routine direct patient contact;
  • Works part-time;
  • Already received current season's flu vaccine more than 48 hours before enrollment and, thus, cannot complete blood draw prior to full immune response to the vaccine;
  • Not be a member of the Clalit Health System health plan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Soroka Medical Center

Beersheba, 85025, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Related Publications (1)

  • 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: 30400834DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens and respiratory specimens will be collected.

MeSH Terms

Conditions

Respiratory Tract DiseasesInfluenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Mark Thompson, PhD

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2016

First Posted

November 6, 2017

Study Start

September 28, 2016

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 31, 2024

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(2)