Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-28 @ 8:48 PM
Study NCT ID:
NCT03748160
Status:
COMPLETED
Last Update Posted:
2025-08-20
First Post:
2018-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Herd Immunity and Influenza Vaccine Uptake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065822', 'term': 'College Fraternities and Sororities'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster (household) RCT with three treatment arms'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2018-11-01', 'studyFirstSubmitQcDate': '2018-11-19', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Heterogeneity', 'timeFrame': 'up to six months (beginning from November 1 / until April 30)', 'description': 'We run the statistical analysis by municipality to study ATE in areas with low/high historical vaccine uptake'}], 'primaryOutcomes': [{'measure': 'Vaccine uptake', 'timeFrame': 'up to six months (beginning from November 1 / until April 30)', 'description': 'Number of influenza vaccinations in study population'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza, Human']}, 'referencesModule': {'references': [{'pmid': '35139082', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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.\n\nThe 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:\n\nT1 (Mailing) - Standard letter T2 (Herd) - Herd immunity letter"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 65 year old citizens in the municipalities of Espoo, Maalahti, Korsnäs, Kristiinankaupunki, Kaskinen and Närpiö\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03748160', 'acronym': 'HIIVU', 'briefTitle': 'Herd Immunity and Influenza Vaccine Uptake', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Finnish Institute for Health and Welfare'}, 'officialTitle': 'Herd Immunity Communication and Influenza Vaccine Uptake', 'orgStudyIdInfo': {'id': '240317'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': '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.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mailing', 'description': '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.', 'interventionNames': ['Other: Letter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Herd', 'description': '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.', 'interventionNames': ['Other: Letter']}], 'interventions': [{'name': 'Letter', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Herd', 'Mailing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00271', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'National Institute for Health and Welfare', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Cornelia Betsch, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Erfurt'}, {'name': 'Robert Böhm, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RTWH Aachen University'}, {'name': 'Hanna Nohynek, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Finnish Institute for Health and Welfare'}, {'name': 'Saila Pitkänen, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Finnish Institute for Health and Welfare'}, {'name': 'Heini Salo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Finnish Institute for Health and Welfare'}, {'name': 'Lauri Sääksvuori, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Finnish Institute for Health and Welfare'}, {'name': 'Jonas Sivelä, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Finnish Institute for Health and Welfare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This study is based in administrative register follow-up. We will share pseudonymized data according to current data availability regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Finnish Institute for Health and Welfare', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'RWTH Aachen University', 'class': 'OTHER'}, {'name': 'University of Erfurt', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}