ClinicalTrials.gg
CompletedNCT03331991HCPUpdated Jul 31, 2024

Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel

An observational study in Respiratory Tract Disease and Influenza, sponsored by Abt Associates. Completed at 2 sites in Israel. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-31.

Primary conditionInfluenza, HumanRegistry: Respiratory Tract DiseasesReclassifiedWhy we changed it
Registry
Respiratory Tract Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Influenza, Human
Why
  1. The study's listed conditions name Influenza, Human, a narrower term within Respiratory Tract Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Abt Associates · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,400
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 36 studies in Influenza, Human with a site in Israel — 3 open to participants now, 3 under way, 2 of them phase 3. Influenza, Human · Israel.

Started
2016
with 1 other
Observational
7 of 36
1 open now
Registered
25th of 36
by date
Lead sponsor
1 of 36
Abt Associates

Among the 36 studies in Influenza, Human with a site in Israel, this one is one of 2 that started in 2016, is one of 7 observational ones, and was the 25th registered.

Influenza, Human

2,358 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.

Browse Influenza, Human studies →

Open to participants now

3 of the 36 studies in Influenza, Human with a site in Israel are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Israel have not opened yet or have stopped. Only those recruiting at a site in Israel →

Who these studies take

Of the 121 Influenza, Human studies recruiting now, 66 (55%) set no upper age limit and 45 (37%) stop at 75 or younger; 33 take children under 18; 67 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 36 studies in Influenza, Human with a site in Israel, or all of them as a file.
02

Study 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.

Read the detailed description

Healthcare personnel (HCP) are believed to be at increased risk of influenza infection and often work while ill, which increases the risk of secondary exposure to vulnerable patients. Vaccination of HCP against influenza is an important component of infection control in healthcare settings, but persistently low rates of vaccine uptake among HCP remains a topic of international concern and debate. Although recent reviews confirm that the seasonal influenza vaccine is moderately effective in reducing the risk of influenza illness [10], multiple gaps in knowledge remain regarding the preventive value of vaccine among HCP.

During at least two consecutive influenza seasons or years, this prospective cohort study of healthcare personnel in middle-income countries has four primary objectives: (1) Describe the frequency and impact of acute respiratory illnesses (ARI) among HCP during wintertime; (2) Estimate the effectiveness of influenza vaccine in preventing symptomatic influenza illness, missed work due to influenza illness, and hours of direct patient care provided by HCP with symptomatic influenza infections; (3) Examine the association between repeated influenza vaccination and HCP's baseline immune landscape, their response to influenza vaccines, and their subsequent protection against infection; (4) Examine if influenza vaccine modifies symptom severity and duration among HCP with breakthrough influenza infections despite vaccination.

Approximately 2,400-2,800 HCP providing direct patient care will be enrolled in a prospective cohort to be followed for at least two years (or two influenza seasons). In Israel, approximately 1,200 HCPs will be enrolled in Year 1 of the study, with an expansion to full enrollment in Year 2. Thus, the investigators anticipate a 3 year cohort study in which \~1,200 participants will contribute to years 1 and 2 of the study and the remaining sample will contribute to years 2 and 3 of the study. Information on socio-demographic characteristics, current medical conditions, medical history, medical care utilization, and influenza vaccination history will be extracted from medical and employee records with the participant's permission. Other information on socio-demographics, occupational responsibilities, health status, and knowledge and attitudes about viruses and vaccines will be collected by self-report through an enrollment survey. Collection of blood specimens will occur prior to and after influenza seasons during each study year; in addition, HCP who receive the influenza vaccine will provide an additional blood draw 21-42 days after vaccination. Active surveillance to identify acute illnesses (associated with cough, runny nose, body aches, or feverishness) will occur twice-weekly during weeks of local influenza circulation. When an acute illness is identified, participants will provide a respiratory specimen (nasal self-swab) for influenza testing and complete two brief surveys during and after resolution of their illness. For a sub-sample of consented participants, additional information on attitudes toward morbidity with influenza and respiratory illness will be collected through in-depth qualitative interviews. Additional brief surveys will be completed at the end of each season/year and at the start of the second influenza season to update information on participant health, work responsibilities, and attitudes and practices associated with vaccination and other inflection control and prevention measures.

03

Conditions studied

  • Respiratory Tract Disease
  • Influenza

Browse trials for

04

In context

Influenza, Human Reclassified

2,358 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.

This study's enrollment of 2,400 is above the median of 397 across 334 observational studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Abt Associates is the lead sponsor of 6 studies on the registry; none are open to participants now.

Compared within Influenza, Human, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Respiratory Tract Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthcare personnel

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
06

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,400 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • Biologicalinfluenza vaccine

    exposure to influenza vaccine

07

What researchers measure

Primary outcomes

  1. Frequency of acute respiratory illness among healthcare personnel receiving influenza vaccine

    Time frame: 3 years

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

    Time frame: 3 years

Secondary outcomes

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

    Time frame: 3 years

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

    Time frame: 3 years

08

Study locations

2 sites
  • Soroka Medical Center
    Beer sheva, 85025, Israel
  • Rabin Medical Center
    Petah Tikva, Israel
09

References and documents

Publications

  • 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. PubMed 30400834 ↗

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2016 to primary completion in Jul 2019, 34 months.

Of 37 industry-sponsored observational studies under Influenza, Human, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 34. This study's 34 months is above that.

Counting every sponsor, half of 135 studies reached it within 23 months; a quarter within 7 and three quarters within 59.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 27, 2016
First posted
Nov 6, 2017
StartActual
Sep 28, 2016
Primary completionActual
Jul 2019
CompletionActual
Jul 2019
Last update
Jul 31, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03331991
Lead sponsor
Abt Associates
Collaborators
Centers for Disease Control and Prevention, Clalit Research Institute
Responsible party
Sponsor
First posted
Nov 6, 2017
Start date
Sep 28, 2016
Primary completion
Jul 2019
Completion
Jul 2019
Last update
Jul 31, 2024

Study contacts

Mark Thompson, PhD
principal investigator · Centers for Disease Control and Prevention

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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