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RecruitingNCT03323112Updated Aug 20, 2025

Immune Responses in Health Care Personnel

An observational study in Influenza, sponsored by Finnish Institute for Health and Welfare. Recruiting at 1 site in Finland. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-20.

Sponsored by Finnish Institute for Health and Welfare · Observational

From the registry’s dates

  • Started Oct 2017; still recruiting 9 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 64 Years
Sex
All
01

Study summary

This is an investigator-initiated 10 year long open cohort observational study, aiming to increase the understanding of the humoral and cellular immunological mechanisms of vaccination against influenza, including effects of repeated vaccination, the duration of protection, immunity against circulating viruses, as well as factors affecting the immunological responses and immunity against other vaccine preventable infectious diseases among health care personnel.

Read the detailed description

Influenza vaccination is given according to the normal routine of Hospital District of Helsinki and Uusimaa (HUS) occupational health care. Blood samples will be collected before vaccination, 5 weeks after vaccination and 6 months after vaccination. Both the same participants and also new participants will be recruited each year. The analysis will be mainly descriptive.

02

Conditions studied

  • Influenza

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Keywords

  • influenza
  • vaccination
  • health care workers
  • immune responses
  • humoral immunity
  • cellular immunity
03

In context

Influenza, Human

2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.

This study's planned enrollment of 150 is below the median of 388 across 332 observational studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Finnish Institute for Health and Welfare is the lead sponsor of 42 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Health care professionals affiliated by HUS

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

  • Members of health care or laboratory personnel in HUS having decided to take the seasonal influenza vaccination by the routine occupational health care service
  • General good health as established by or volunteer's own statement
  • Written
  • Presumably able and willing to participate in the study during the starting influenza season

Exclusion criteria

Exclusion Criteria:

  • Any confirmed or suspected or immunodeficient condition, including (HIV) infection.
  • Administration (longer than 14 days) of immunosuppressants or other immune- modifying drugs within 6 months before the vaccination; oral in dosages of 20 mg/day or more prednisolone or equivalent are excluded; inhaled or topical steroids are allowed.
  • Pregnancy or lactation
  • Acute disease at the time of enrolment (defined as the presence of a moderate or severe illness with or without fever)
  • for influenza vaccination
  • Any other criteria which, in the investigator's or dedicated study staff member's opinion, would compromise the ability of a subject to participate in the study, a subject's well-being, or the outcome of the study
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Influenza vaccine recipients

    Health care workers vaccinated by their occupational health care according to the routine praxis.

    Biological: influenza vaccine

Interventions

  • Biologicalinfluenza vaccine

    Vaccine for prevention of influenza. Vaccines change by influenza season.

06

What researchers measure

Primary outcomes

  1. Humoral immunity against each present season's vaccine and circulating influenza strains

    The presence and titer of antibodies against circulating influenza virus strains and vaccine strains of the current season from pre- and post-vaccination serum samples

    Time frame: 10 years

Secondary outcomes

  1. Humoral immunity against previous seasons' vaccine and circulating influenza strains

    To assess the presence and titer of antibodies to circulating influenza strains and vaccine virus strains of previous seasons from pre- and post-vaccination serum samples

    Time frame: 10 years

  2. Cellular immunity against current and previous seasons' vaccine and circulating influenza strains

    The cellular immune responses to circulating influenza viruses and vaccine strains of the current and previous seasons from pre- and post-vaccination peripheral blood mononuclear cells (PBMCs) and cell culture supernatants

    Time frame: 10 years

  3. Effect of repeated vaccination against influenza

    The effect of the number of previous influenza vaccinations on the quality and quantity of Humoral and cellular immunity to circulating influenza strains and vaccine strains of the current and previous seasons

    Time frame: 10 years

Other outcomes

  1. Factors affecting humoral and/or cellular immune responses to influenza viruses or vaccination

    Exploration of biological or chemical factors that are/will be known or suspected to affect the humoral and/or cellular immune responses to influenza viruses or vaccination

    Time frame: 10 years

  2. Immunity against other microbes causing vaccine preventable diseases among health care workers

    Assessment of humoral and cellular immunity to microbes other than influenza virus causing vaccine preventable diseases

    Time frame: 10 years

  3. Developing methods to measure immunity against vaccine preventable diseases

    developing laboratory methodologies to assess immunity to influenza and other microbes causing vaccine preventable diseases

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03323112
Lead sponsor
Finnish Institute for Health and Welfare
Collaborators
Hospital District of Helsinki and Uusimaa
Responsible party
Sponsor
First posted
Oct 26, 2017
Start date
Oct 18, 2017
Primary completion
Oct 14, 2027 (estimated)
Completion
Oct 14, 2027 (estimated)
Last update
Aug 20, 2025

Study contacts

Hanna Nohynek, MD, PhD
Contact
hanna.nohynek@thl.fi
+358 29 524 8246
Merit Melin, PhD
Contact
merit.melin@thl.fi
+358 29 524 8903
Hanna Nohynek, MD, PhD
principal investigator · Finnish Institute for Health and Welfare

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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