Clinical trial NCT02909855: Factors Associated With Parental Observation of Side Effects Following the Child Flu Vaccine
Official title: Factors Associated With Parental Observation of Side Effects Following the Child Flu Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza Vaccine, Influenza
Keywords: children
psychological predictors
side-effects
vaccination
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Number of participants who perceive their child to have treatment-related adverse events from the child flu vaccine
timeFrame: October 2016 - March 2017
Secondary outcomes:
measure: Intention to re-vaccinate child
timeFrame: October 2016 - March 2017
measure: Negative interpretative bias scores as assessed by the scrambled sentences and similarity ratings tasks
timeFrame: October 2016 - March 2017
Other outcomes:
measure: Vaccination status of child for flu at end of 2017/18 flu season
timeFrame: January - March 2018
Locations:
city: London
country: United Kingdom
facility: Albion Street Group Practice
city: London
country: United Kingdom
facility: Claremont Medical Centre
city: London
country: United Kingdom
facility: Herne Hill Group Practice
city: London
country: United Kingdom
facility: Honor Oak Group Practice
city: London
country: United Kingdom
facility: Hurley Clinic
city: London
country: United Kingdom
facility: Links Medical Practice
city: London
country: United Kingdom
facility: Morden Hall Medical Centre
city: London
country: United Kingdom
facility: Park Group Practice
city: London
country: United Kingdom
facility: Paxton Green Group Practice
city: London
country: United Kingdom
facility: The Rosendale Surgery
city: London
country: United Kingdom
facility: Woodlands Practice
Study officials:
affiliation: King's College London
name: G James Rubin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.