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Recruiting NCT03323112

Immune Responses in Health Care Personnel

Observational Influenza

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: influenza vaccine.
Who it may be relevant to
Registry conditions: Influenza. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Immune Responses to Influenza Vaccinations and Viruses Among Health Care Personnel

Overview

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.

Interventions

  • Biological influenza vaccine
    Vaccine for prevention of influenza. Vaccines change by influenza season.

Primary outcome measures

  • Humoral immunity against each present season's vaccine and circulating influenza strains [Time frame: 10 years]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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 informed consent
  • Presumably able and willing to participate in the study during the starting influenza season

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Finland · 1 center
  • The Hospital District of Helsinki and Uusimaa — Helsinki

Identifiers

NCT: NCT03323112 · FinFLU_HCPimmu_2017THL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗