InfluenzaNCT03323112
Immune Responses in Health Care Personnel
An observational study of Influenza, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- influenza vaccine
- Type of treatment
- Vaccines
- How many people
- 150 participants
- Where
- 1 siteFinland
- Study dates
- 18 Oct 2017to 14 Oct 2027
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Health care professionals affiliated by HUS
Who may be able to join
- 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 informed consent
- Presumably able and willing to participate in the study during the starting influenza season
Who cannot join
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- Administration (longer than 14 days) of immunosuppressants or other immune- modifying drugs within 6 months before the vaccination; oral corticosteroids 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)
- Contraindication 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
The Hospital District of Helsinki and Uusimaa
Helsinki
Veli-Jukka Anttila, MD, Docent, +358 50 4271512, veli-jukka.anttila@hus.fi
About this study
Official title: Immune Responses to Influenza Vaccinations and Viruses Among Health Care Personnel
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.
- Conditions
- Influenza
- Being tested
- influenza vaccine
- Keywords
- influenza, vaccination, health care workers, immune responses, humoral immunity, cellular immunity
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
influenza vaccineBiological
Vaccine for prevention of influenza. Vaccines change by influenza season.
| Study group | Role | What they receive |
|---|---|---|
| Influenza vaccine recipients | Health care workers vaccinated by their occupational health care according to the routine praxis. Receives: Biological: influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Secondary outcomes (3)
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
Measured: 10 years
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
Measured: 10 years
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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start18 Oct 2017
- Primary completion14 Oct 2027 (estimated)
- Study completion14 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Hospital District of Helsinki and Uusimaa
- Responsible party
- Sponsor
- Investigators
- Hanna Nohynek, MD, PhD, Principal investigator, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323112
- Sponsor's protocol ID
- FinFLU_HCPimmu_2017THL
- Status last verified
- Aug 2025
- First submitted
- 13 Oct 2017
- Last updated
- 20 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Responses to Influenza Vaccinations and Viruses Among Health Care Personnel
- ClinicalTrials.gov ID
- NCT03323112
- Acronym / sponsor ID
- FinFLU_HCPimmu_2017THL
- Conditions
- Influenza
- Keywords
- influenza, vaccination, health care workers, immune responses, humoral immunity, cellular immunity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Hospital District of Helsinki and Uusimaa
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 14 Oct 2027 (estimated)
- Study completion
- 14 Oct 2027 (estimated)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccine recipients | – | Biological: influenza vaccineHealth care workers vaccinated by their occupational health care according to the routine praxis. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Health care professionals affiliated by HUS
Key inclusion criteria (4 listed)
- 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 informed consent
- Presumably able and willing to participate in the study during the starting influenza season
Key exclusion criteria (6 listed)
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- Administration (longer than 14 days) of immunosuppressants or other immune- modifying drugs within 6 months before the vaccination; oral corticosteroids 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)
- Contraindication for influenza vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| influenza vaccineVaccine for prevention of influenza. Vaccines change by influenza season. | Biological | Influenza vaccine recipients |
Primary outcome
Humoral immunity against each present season's vaccine and circulating influenza strains
Time frame: 10 years
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
3 secondary outcomes
Humoral immunity against previous seasons' vaccine and circulating influenza strains
Time frame: 10 years
Cellular immunity against current and previous seasons' vaccine and circulating influenza strains
Time frame: 10 years
Effect of repeated vaccination against influenza
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanna Nohynek, MD, PhD principal investigator
Finnish Institute for Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by Finnish Institute for Health and Welfare at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanna Nohynek, MD, PhD (+358 29 524 8246, hanna.nohynek@thl.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humoral immunity against each present season's vaccine and circulating influenza strains (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.