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OpenTrials
Completed

NCT Number: NCT02909855

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Albion Street Group Practice, London, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Intention to re-vaccinate child

    Time frame: October 2016 - March 2017

    Using a scale as a method of assessment

  2. Negative interpretative bias scores as assessed by the scrambled sentences and similarity ratings tasks

    Time frame: October 2016 - March 2017

Other outcomes

  1. Vaccination status of child for flu at end of 2017/18 flu season

    Time frame: January - March 2018

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Sep 21, 2016
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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