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

August 8, 2018 updated by: King's College London
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Park Group Practice
      • London, United Kingdom
        • Albion Street Group Practice
      • London, United Kingdom
        • Claremont Medical Centre
      • London, United Kingdom
        • Herne Hill Group Practice
      • London, United Kingdom
        • Honor Oak Group Practice
      • London, United Kingdom
        • Hurley Clinic
      • London, United Kingdom
        • Links Medical Practice
      • London, United Kingdom
        • Morden Hall Medical Centre
      • London, United Kingdom
        • Paxton Green Group Practice
      • London, United Kingdom
        • The Rosendale Surgery
      • London, United Kingdom
        • Woodlands Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • 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

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants
Parents of children aged 2-4 who will receive the child flu vaccine from their general practitioner (GP)
Other: No intervention
Participants in this study will not receive any interventions as part of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who perceive their child to have treatment-related adverse events from the child flu vaccine
Time Frame: October 2016 - March 2017
Using questionnaire materials as a method of assessment
October 2016 - March 2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intention to re-vaccinate child
Time Frame: October 2016 - March 2017
Using a scale as a method of assessment
October 2016 - March 2017
Negative interpretative bias scores as assessed by the scrambled sentences and similarity ratings tasks
Time Frame: October 2016 - March 2017
October 2016 - March 2017

Other Outcome Measures

Outcome Measure
Time Frame
Vaccination status of child for flu at end of 2017/18 flu season
Time Frame: January - March 2018
January - March 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Investigators

  • Principal Investigator: G James Rubin, PhD, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

September 13, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/LO/1003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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