Factors Associated With Parental Observation of Side Effects Following the Child Flu Vaccine

NCT ID: NCT02909855

Last Updated: 2018-08-09

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

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Recruitment Status

COMPLETED

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-05-31

Brief Summary

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This study investigates whether there are psychological predictors of parental perception of side-effects following vaccination with the child flu vaccine. We will also investigate whether the perception of side-effects affects parents' intention to vaccinate their child again in the following flu season, as well as whether there are underlying differences in parents' cognitive biases between those who do and do not re-vaccinate their child.

Detailed Description

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In 2012, the British Joint Committee on Vaccination and Immunisation (JCVI) recommended that the influenza vaccination programme be extended to include children aged 2 to 16. In the three flu seasons in which the child flu immunisation programme has been running (2013-14, 2014-15, 2015-16), uptake rates have been low (approximately 40%). Multiple factors are likely to underlie the poor uptake, including thinking the vaccine was unsafe and ineffective and having experienced side-effects related to the vaccine previously.

Although symptoms are commonly reported following vaccinations, their causes are not always straightforward. Although a minority may be directly attributable to the vaccine itself, others may reflect pre-existing or coincidental symptoms that are misattributed to the vaccine. Following vaccination, an expectation that the vaccine causes side-effects may also contribute to parents detecting symptoms in their child that might otherwise have gone unnoticed. Perception of side-effects may also influence the parent's decision to vaccinate their child again in following years.

Other possible factors influencing parents' perception of side-effects and their willingness to vaccinate their child again are their personal health beliefs and their interpretations of the information they are given about vaccination and side-effects. These cognitive processes can be measured objectively using experimental tasks, and can reveal characteristic patterns, or 'cognitive biases' which govern behaviour.

Conditions

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Influenza Vaccine, Influenza

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants

Parents of children aged 2-4 who will receive the child flu vaccine from their general practitioner (GP)

No intervention

Intervention Type OTHER

Participants in this study will not receive any interventions as part of the study.

Interventions

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No intervention

Participants in this study will not receive any interventions as part of the study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Parents of guardians of children aged 2-4 on 31st August 2016 (i.e. born September 1st 2011 to August 31st 2014) who receive the flu vaccine at the GP
* Parents must be aged 18 or over
* Parents must be fluent in English

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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G James Rubin, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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Albion Street Group Practice

London, , United Kingdom

Site Status

Claremont Medical Centre

London, , United Kingdom

Site Status

Herne Hill Group Practice

London, , United Kingdom

Site Status

Honor Oak Group Practice

London, , United Kingdom

Site Status

Hurley Clinic

London, , United Kingdom

Site Status

Links Medical Practice

London, , United Kingdom

Site Status

Morden Hall Medical Centre

London, , United Kingdom

Site Status

Park Group Practice

London, , United Kingdom

Site Status

Paxton Green Group Practice

London, , United Kingdom

Site Status

The Rosendale Surgery

London, , United Kingdom

Site Status

Woodlands Practice

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Smith LE, Amlot R, Weinman J, Yiend J, Rubin GJ. Why do parents not re-vaccinate their child for influenza? A prospective cohort study. Vaccine. 2020 Jun 2;38(27):4230-4235. doi: 10.1016/j.vaccine.2020.04.029. Epub 2020 May 5.

Reference Type DERIVED
PMID: 32386745 (View on PubMed)

Smith LE, Weinman J, Amlot R, Yiend J, Rubin GJ. Parental Expectation of Side Effects Following Vaccination Is Self-fulfilling: A Prospective Cohort Study. Ann Behav Med. 2019 Mar 1;53(3):267-282. doi: 10.1093/abm/kay040.

Reference Type DERIVED
PMID: 29868792 (View on PubMed)

Other Identifiers

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16/LO/1003

Identifier Type: -

Identifier Source: org_study_id

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