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

Influenza Vaccine, Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909855
• Other study ID #: 16/LO/1003
• Status: Completed
• Start date: October 2016
• Est. completion date: May 2018

Study information

• Verified date: August 2018
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: May 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Influenza Vaccine, Influenza
• Influenza, Human

Intervention

Other:
• No intervention
Participants in this study will not receive any interventions as part of the study.

Locations

Country	Name	City	State
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	Park Group Practice	London
United Kingdom	Paxton Green Group Practice	London
United Kingdom	The Rosendale Surgery	London
United Kingdom	Woodlands Practice	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vaccination status of child for flu at end of 2017/18 flu season		January - March 2018
Primary	Number of participants who perceive their child to have treatment-related adverse events from the child flu vaccine	Using questionnaire materials as a method of assessment	October 2016 - March 2017
Secondary	Intention to re-vaccinate child	Using a scale as a method of assessment	October 2016 - March 2017
Secondary	Negative interpretative bias scores as assessed by the scrambled sentences and similarity ratings tasks		October 2016 - March 2017

External Links

•   Study website