NCT05479383

Brief Summary

This is an observational study of participants in two general population health surveys (FinSote 2018 and 2020) who are followed up for their COVID-19 vaccinations or end of follow-up. The primary objective is to examine the association between tobacco use and COVID-19 vaccine uptake and between-dose spacing.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42,935

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 2, 2017

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

5.7 years

First QC Date

July 28, 2022

Last Update Submit

May 3, 2023

Conditions

Keywords

Tobacco useSmokingCOVID-19SARS-CoV-2VaccinationsCohort studies

Outcome Measures

Primary Outcomes (1)

  • Vaccination uptake of at least two doses of a COVID-19 vaccine

    Proportion of participants with at least two doses of a COVID-19 vaccine

    Baseline until date of vaccination or May 31, 2022

Secondary Outcomes (4)

  • Vaccination uptake of at least one dose of a COVID-19 vaccine

    Baseline until date of vaccination or May 31, 2022

  • Vaccination uptake of complete COVID-19 vaccination scheme (two doses and a booster dose)

    Baseline until date of vaccination or May 31, 2022

  • Spacing of first and second COVID-19 dose

    Baseline until date of vaccination or May 31, 2022

  • Spacing of second dose and booster dose of the COVID-19 vaccine

    Baseline until date of vaccination or May 31, 2022

Study Arms (1)

Tobacco users

Tobacco users Never smokers (reference group) will be compared with former smokers, occasional smokers and daily smokers. Never snus users (reference group) will also compare with never users, former users and current users.

Other: Not applicable, this is an observational study

Interventions

Not applicable, this is an observational study

Tobacco users

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Permanent residents in Finland aged 20 and over who participated in the FinSote surveys in 2018 and 2020. These are general population samples representative of the Finnish population. The sampling frame was the Population Register (in 2020 the Digital and Population Data Services Agency, created after the merge between the Population Register of Statistics Finland and local register offices), which includes all individuals residing permanently in Finland, including conscripts and people living in institutions.

You may qualify if:

  • Permanent residents of Finland
  • Registered in the Population Register at the moment of sampling
  • Aged 20 and over
  • Participated in the FinSote surveys in 2018 or 2020
  • Provided consent for register linkage

You may not qualify if:

  • Temporary residents in Finland or tourists
  • Age less than 20 years old
  • Did not participate in FinSote surveys in 2018, 2019 and 2020
  • Did not provide consent for register linkage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Finnish Institute for Health and Welfare

Helsinki, Uusimaa, 00271, Finland

Location

Related Publications (13)

  • Simons D, Shahab L, Brown J, Perski O. The association of smoking status with SARS-CoV-2 infection, hospitalization and mortality from COVID-19: a living rapid evidence review with Bayesian meta-analyses (version 7). Addiction. 2021 Jun;116(6):1319-1368. doi: 10.1111/add.15276. Epub 2020 Nov 17.

    PMID: 33007104BACKGROUND
  • Jackson SE, Paul E, Brown J, Steptoe A, Fancourt D. Negative Vaccine Attitudes and Intentions to Vaccinate Against Covid-19 in Relation to Smoking Status: A Population Survey of UK Adults. Nicotine Tob Res. 2021 Aug 18;23(9):1623-1628. doi: 10.1093/ntr/ntab039.

    PMID: 33751125BACKGROUND
  • Krebs NM, D'Souza G, Bordner C, Allen SI, Hobkirk AL, Foulds J, Yingst JM. COVID-19 Vaccination Uptake and Hesitancy Among Current Tobacco Users. Tob Use Insights. 2021 Dec 20;14:1179173X211068027. doi: 10.1177/1179173X211068027. eCollection 2021.

    PMID: 34987300BACKGROUND
  • Ali M, Ahmed S, Bonna AS, Sarkar AS, Islam MA, Urmi TA, Proma TS. Parental coronavirus disease vaccine hesitancy for children in Bangladesh: a cross-sectional study. F1000Res. 2022 Jan 25;11:90. doi: 10.12688/f1000research.76181.2. eCollection 2022.

    PMID: 35211297BACKGROUND
  • Oruc MA, Ozturk O. Attitudes of health care professionals towards COVID-19 vaccine - a sequence from Turkey. Hum Vaccin Immunother. 2021 Oct 3;17(10):3377-3383. doi: 10.1080/21645515.2021.1928462. Epub 2021 Jun 18.

    PMID: 34142925BACKGROUND
  • Wu J, Li Q, Silver Tarimo C, Wang M, Gu J, Wei W, Ma M, Zhao L, Mu Z, Miao Y. COVID-19 Vaccine Hesitancy Among Chinese Population: A Large-Scale National Study. Front Immunol. 2021 Nov 29;12:781161. doi: 10.3389/fimmu.2021.781161. eCollection 2021.

    PMID: 34912346BACKGROUND
  • Luk TT, Zhao S, Wu Y, Wong JY, Wang MP, Lam TH. Prevalence and determinants of SARS-CoV-2 vaccine hesitancy in Hong Kong: A population-based survey. Vaccine. 2021 Jun 16;39(27):3602-3607. doi: 10.1016/j.vaccine.2021.05.036. Epub 2021 May 18.

    PMID: 34034950BACKGROUND
  • Wisniak A, Baysson H, Pullen N, Nehme M, Pennacchio F, Zaballa ME, Guessous I, Stringhini S; Specchio-COVID19 study group. COVID-19 vaccination acceptance in the canton of Geneva: a cross-sectional population-based study. Swiss Med Wkly. 2021 Dec 14;151:w30080. doi: 10.4414/smw.2021.w30080. eCollection 2021 Dec 6.

    PMID: 34908389BACKGROUND
  • Ishimaru T, Okawara M, Ando H, Hino A, Nagata T, Tateishi S, Tsuji M, Matsuda S, Fujino Y; CORoNaWork Project. Gender differences in the determinants of willingness to get the COVID-19 vaccine among the working-age population in Japan. Hum Vaccin Immunother. 2021 Nov 2;17(11):3975-3981. doi: 10.1080/21645515.2021.1947098. Epub 2021 Jul 2.

    PMID: 34213406BACKGROUND
  • Ko T, Dendle C, Woolley I, Morand E, Antony A. SARS-COV-2 vaccine acceptance in patients with rheumatic diseases: a cross-sectional study. Hum Vaccin Immunother. 2021 Nov 2;17(11):4048-4056. doi: 10.1080/21645515.2021.1958611. Epub 2021 Aug 6.

    PMID: 34357827BACKGROUND
  • Tan LF, Huak CY, Siow I, Tan AJ, Venugopalan PM, Premkumar A, Seetharaman SK, Tan BYQ. The road to achieving herd immunity: factors associated with Singapore residents' uptake and hesitancy of the COVID-19 vaccination. Expert Rev Vaccines. 2022 Apr;21(4):561-567. doi: 10.1080/14760584.2022.2021883. Epub 2022 Jan 11.

    PMID: 34937504BACKGROUND
  • Tiirinki H, Viita-Aho M, Tynkkynen LK, Sovala M, Jormanainen V, Keskimaki I. COVID-19 in Finland: Vaccination strategy as part of the wider governing of the pandemic. Health Policy Technol. 2022 Jun;11(2):100631. doi: 10.1016/j.hlpt.2022.100631. Epub 2022 Apr 14.

    PMID: 35437478BACKGROUND
  • Pena S, Zhou Z, Kestila L, Galanti MR, Shaaban AN, Caspersen IH, Magnus P, Geraldo P, Rojas-Saunero P, Parikka S, Nohynek H, Karvonen S. Tobacco Use and Uptake of COVID-19 Vaccinations in Finland: A Population-Based Study. Nicotine Tob Res. 2024 Oct 22;26(11):1553-1562. doi: 10.1093/ntr/ntad234.

Related Links

MeSH Terms

Conditions

COVID-19SmokingTobacco UseVaccination Refusal

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehaviorTreatment RefusalTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Sakari Karvonen, PhD

    Finnish Institute for Health and Welfare

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 28, 2022

First Posted

July 29, 2022

Study Start

October 2, 2017

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Researchers can access individual data by contacting the Responsible Researcher at the Finnish Institute for Health and Welfare, Suvi Parikka, suvi.parikka \[at\] thl.fi. Information about FinSote surveys, including questionnaires, can be found in https://thl.fi/fi/tutkimus-ja-kehittaminen/tutkimukset-ja-hankkeet/finsote-tutkimus

Locations