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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02909855
Enrollment
270
Registered
2016-09-21
Start date
2016-10-31
Completion date
2018-05-31
Last updated
2018-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza Vaccine, Influenza

Keywords

children, psychological predictors, side-effects, vaccination

Brief summary

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

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.

Interventions

OTHERNo intervention

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

Sponsors

King's College London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Number of participants who perceive their child to have treatment-related adverse events from the child flu vaccineOctober 2016 - March 2017Using questionnaire materials as a method of assessment

Secondary

MeasureTime frameDescription
Intention to re-vaccinate childOctober 2016 - March 2017Using a scale as a method of assessment
Negative interpretative bias scores as assessed by the scrambled sentences and similarity ratings tasksOctober 2016 - March 2017

Other

MeasureTime frame
Vaccination status of child for flu at end of 2017/18 flu seasonJanuary - March 2018

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026