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CompletedNCT03748160HIIVUUpdated Aug 20, 2025

Herd Immunity and Influenza Vaccine Uptake

An interventional study of Letter in Influenza, Human, sponsored by Finnish Institute for Health and Welfare. Completed at 1 site in Finland. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-20.

Sponsored by Finnish Institute for Health and Welfare · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
48,125
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

The aim of this study is to test the effectiveness of communicating the concept of herd immunity on actual influenza vaccine uptake using a randomized controlled trial.

Read the detailed description

The investigators run a large-scale randomized controlled trial (RCT) to understand behavioural processes that guide decisions to vaccinate and test alternative strategies to communicate the concept of herd immunity. The experiment varies the text of postal letters send to individuals eligible for free influenza vaccines. The experiment is run in collaboration with the municipal health authorities.

The investigators identify from the Population Register all individuals who are born in year 1953 or before and resided in the participating municipality on October 01, 2018. The investigators will obtain the postal addresses of these individuals using the Population Register and randomly assign individuals to treatment conditions that differ in the wording of the information material and reception of a text message. Importantly, the extract from the Population Register will also include an individual identifier (social security number) that can be used to match the received type of letter (treatment) with the actual vaccination decision recorded in the Care Register for Health Care to objectively evaluate the impact of received information on vaccine uptake. The matching of postal addresses and vaccination data will be conducted using pseudonymized identifiers. The pseudonymization of individual identifiers will be performed separately for both datasets by professional data management and data security staff of the National Institute for Health and Welfare. The investigators conducting the data analysis will be able to access only pseudonymous data without a possibility to directly identify individuals from the data set. The data will be stored according to the data protection legislation and regulations of the National Institute for Health and Welfare during the research project.

The investigators randomly assign individuals to treatment conditions that differ in the wording of the letters. The authority's standard letter serves as the baseline condition (T1). This letter is extended by communicating the concept of herd immunity and appealing to pro-social preferences by highlighting the fact that vaccinations may effectively prevent infections among people who are not able to vaccinate themselves (especially babies) (T2). To summarize, this study includes a control treatment (T0, no letter) and two active treatment arms with the following contents:

T1 (Mailing) - Standard letter T2 (Herd) - Herd immunity letter

02

Conditions studied

  • Influenza, Human

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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 enrollment of 48,125 is above the median of 227 across 1,957 interventional 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
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • At least 65 year old citizens in the municipalities of Espoo, Maalahti, Korsnäs, Kristiinankaupunki, Kaskinen and Närpiö

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
48,125 participants (actual)

Study arms

  • No intervention
    Control

    There is no intervention (letter) in the control arm. There is no control arm in the city of Espoo. 1/3 of subjects in all other municipalities are assigned to the control arm.

  • Active comparator
    Mailing

    This treatment arm consists of a standard letter reminding elderly citizens (65 years and above) about influenza vaccines that are available free of charge from the local health centers.

    Other: Letter

  • Active comparator
    Herd

    This treatment arm consists of a letter that highlights the herd immunity effects of vaccination and reminds elderly citizens (65 years and above) about influenza vaccines that are available free of charge from the local health centers.

    Other: Letter

Interventions

  • OtherLetter

    Intervention consists of two different types of postal letters reminding elderly citizens (65 years and above) about influenza vaccines that are available free of charge from the local health centers

06

What researchers measure

Primary outcomes

  1. Vaccine uptake

    Number of influenza vaccinations in study population

    Time frame: up to six months (beginning from November 1 / until April 30)

Other outcomes

  1. Heterogeneity

    We run the statistical analysis by municipality to study ATE in areas with low/high historical vaccine uptake

    Time frame: up to six months (beginning from November 1 / until April 30)

07

Study locations

1 site
  • National Institute for Health and Welfare
    Helsinki, 00271, Finland
08

References and documents

Publications

  • Saaksvuori L, Betsch C, Nohynek H, Salo H, Sivela J, Bohm R. Information nudges for influenza vaccination: Evidence from a large-scale cluster-randomized controlled trial in Finland. PLoS Med. 2022 Feb 9;19(2):e1003919. doi: 10.1371/journal.pmed.1003919. eCollection 2022 Feb. PubMed 35139082 ↗

Individual participant data

Plan to share: Undecided — This study is based in administrative register follow-up. We will share pseudonymized data according to current data availability regulations.

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
NCT03748160
Lead sponsor
Finnish Institute for Health and Welfare
Collaborators
RWTH Aachen University, University of Erfurt
Responsible party
Sponsor
First posted
Nov 20, 2018
Start date
Oct 1, 2018
Primary completion
Jun 1, 2019
Completion
Dec 31, 2019
Last update
Aug 20, 2025

Study contacts

Cornelia Betsch, PhD
principal investigator · University of Erfurt
Robert Böhm, PhD
principal investigator · RTWH Aachen University
Hanna Nohynek, PhD
principal investigator · Finnish Institute for Health and Welfare
Saila Pitkänen, MSc
principal investigator · Finnish Institute for Health and Welfare
Heini Salo, PhD
principal investigator · Finnish Institute for Health and Welfare
Lauri Sääksvuori, PhD
study director · Finnish Institute for Health and Welfare
Jonas Sivelä, PhD
principal investigator · Finnish Institute for Health and Welfare

Oversight

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

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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