- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03748160
Herd Immunity and Influenza Vaccine Uptake (HIIVU)
Herd Immunity Communication and Influenza Vaccine Uptake
Study Overview
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Helsinki, Finland, 00271
- National Institute for Health and Welfare
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least 65 year old citizens in the municipalities of Espoo, Maalahti, Korsnäs, Kristiinankaupunki, Kaskinen and Närpiö
Exclusion Criteria:
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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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
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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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vaccine uptake
Time Frame: up to six months (beginning from November 1 / until April 30)
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Number of influenza vaccinations in study population
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up to six months (beginning from November 1 / until April 30)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heterogeneity
Time Frame: up to six months (beginning from November 1 / until April 30)
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We run the statistical analysis by municipality to study ATE in areas with low/high historical vaccine uptake
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up to six months (beginning from November 1 / until April 30)
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Collaborators and Investigators
Investigators
- Principal Investigator: Cornelia Betsch, PhD, University of Erfurt
- Principal Investigator: Robert Böhm, PhD, RTWH Aachen University
- Principal Investigator: Hanna Nohynek, PhD, Finnish Institute for Health and Welfare
- Principal Investigator: Saila Pitkänen, MSc, Finnish Institute for Health and Welfare
- Principal Investigator: Heini Salo, PhD, Finnish Institute for Health and Welfare
- Study Director: Lauri Sääksvuori, PhD, Finnish Institute for Health and Welfare
- Principal Investigator: Jonas Sivelä, PhD, Finnish Institute for Health and Welfare
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 240317
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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