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Influenza 2020/2021

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04546854
Recruitment Status : Completed
First Posted : September 14, 2020
Last Update Posted : September 25, 2020
Information provided by (Responsible Party):
Kelly Ann Schmidtke, University of Warwick

Brief Summary:

As part of the fight against COVID-19, the UK government has announced its most comprehensive flu campaign to date (https://www.gov.uk/government/news/most-comprehensive-flu-programme-in-uk-history-will-be-rolled-out-this-winter). This should not be surpising: every year NHS hospitals experience an overwhelming number of influenza cases, and COVID-19 increases this concern. As in previous years, the flu vaccine is free at the point of care for people 65 and over. New this year is that later in the season the vaccine will be made available free at the point of care for people 50 and over. However, if people refuse to take the vaccine this comprehensive program cannot benefit public health.

The degree to which vaccine hesitancy is expressed varies across characteristics of the vaccine considered and the time and place it is offered, and across characteristics of the person's perceptions of complacency, convenience, confidence, calculations, and communal responsibility, i.e. the "5Cs". Information campaigns can be used to influence all 5Cs, and public facing information is often a necessary component of public health campaigns that may also include structural components. Largely, information campaigns can be viewed as a type of educational intervention.

Educational interventions may fall short of what is needed to alter people's intentions to vaccinate where they focus on system 1 rational thinking processes and neglect system 2 automatic thinking processes. To be more effective, public health messages must be tailored to align with the "beliefs, attitudes, and motivations" of the very people they intend to influence.

Fact-led educational interventions to increase parents' intentions to vaccinate their children are particularly ineffective where more subtle content opposes the recipient's deep-seated values. In a different context, recycling behaviour, previous research demonstrated that messages aligned with people's deep-seated values (i.e. the moral foundations that underlie political ideologies) are more likely to promote desired behavioural intentions than unaligned messages.

The present research expands the scope of previous research in two ways. First, rather than investigating parental attitudes towards vaccination, the investigators will look at people's intentions to self-vaccinate. Second, the investigators will explore the effectiveness of messages aligned with the moral foundations that underlie individual's political ideologies on their intentions to be vaccinated.

Condition or disease Intervention/treatment Phase
Influenza Vaccine Behavioral: Appeals Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Influenza 2020/2021. A Survey to Assess How People's Political Attitudes and Messages Influence Their Behavioral Intentions in the United Kingdom.
Actual Study Start Date : September 21, 2020
Actual Primary Completion Date : September 21, 2020
Actual Study Completion Date : September 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arm Intervention/treatment
Experimental: Conservative - Binding Appeal Behavioral: Appeals
Written text motivating participants to take up the seasonal influenza vaccination

Experimental: Liberal - Individulizing Appeal Behavioral: Appeals
Written text motivating participants to take up the seasonal influenza vaccination

Primary Outcome Measures :
  1. Intentions to take up the seasonal influenza vaccination [ Time Frame: 1 day ]
    Participants rate their intentions to take up the seasonal influenza vaccination on a 7-point likert scale, from strongly disagree (=1) to strongly agree (=7).

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Resident in England
  • Age 50+ years old, inclusive

The age criteria is set at 50+ years old, because this is the age group currently being advised by Public Health England to seek the flu jab as soon as possible this season. (https://www.gov.uk/government/news/most-comprehensive-flu-programme-in-uk-history-will-be-rolled-out-this-winter).

Exclusion Criteria:

  • Not a resident in England
  • Age less than 50 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04546854

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United Kingdom
University of Warwick
Coventry, United Kingdom
Sponsors and Collaborators
University of Warwick
  Study Documents (Full-Text)

Documents provided by Kelly Ann Schmidtke, University of Warwick:
Study Protocol  [PDF] August 28, 2020

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Responsible Party: Kelly Ann Schmidtke, Assistant Professor, University of Warwick
ClinicalTrials.gov Identifier: NCT04546854    
Other Study ID Numbers: BSREC 167/19-20
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases