Herd Immunity and Influenza Vaccine Uptake

NCT ID: NCT03748160

Last Updated: 2025-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza, Human

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster (household) RCT with three treatment arms
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Letter

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Letter

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Letter

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

RWTH Aachen University

OTHER

Sponsor Role collaborator

University of Erfurt

UNKNOWN

Sponsor Role collaborator

Finnish Institute for Health and Welfare

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cornelia Betsch, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Erfurt

Robert Böhm, PhD

Role: PRINCIPAL_INVESTIGATOR

RTWH Aachen University

Hanna Nohynek, PhD

Role: PRINCIPAL_INVESTIGATOR

Finnish Institute for Health and Welfare

Saila Pitkänen, MSc

Role: PRINCIPAL_INVESTIGATOR

Finnish Institute for Health and Welfare

Heini Salo, PhD

Role: PRINCIPAL_INVESTIGATOR

Finnish Institute for Health and Welfare

Lauri Sääksvuori, PhD

Role: STUDY_DIRECTOR

Finnish Institute for Health and Welfare

Jonas Sivelä, PhD

Role: PRINCIPAL_INVESTIGATOR

Finnish Institute for Health and Welfare

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Institute for Health and Welfare

Helsinki, , Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35139082 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

240317

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hutterite Influenza Prevention Study
NCT00877396 COMPLETED PHASE4