NCT02909855

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

September 13, 2016

Last Update Submit

August 8, 2018

Conditions

Influenza Vaccine, Influenza

Keywords

childrenpsychological predictorsside-effectsvaccination

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Intention to re-vaccinate child

    October 2016 - March 2017

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

    October 2016 - March 2017

Other Outcomes (1)

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

    January - March 2018

Study Arms (1)

Participants

Parents of children aged 2-4 who will receive the child flu vaccine from their general practitioner (GP)

Other: No intervention

Interventions

No interventionOTHER

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

Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Albion Street Group Practice

London, United Kingdom

Location

Claremont Medical Centre

London, United Kingdom

Location

Herne Hill Group Practice

London, United Kingdom

Location

Honor Oak Group Practice

London, United Kingdom

Location

Hurley Clinic

London, United Kingdom

Location

Links Medical Practice

London, United Kingdom

Location

Morden Hall Medical Centre

London, United Kingdom

Location

Park Group Practice

London, United Kingdom

Location

Paxton Green Group Practice

London, United Kingdom

Location

The Rosendale Surgery

London, United Kingdom

Location

Woodlands Practice

London, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 32386745DERIVED

  • 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.

    PMID: 29868792DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • G James Rubin, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 21, 2016

Study Start

October 1, 2016

Primary Completion

January 1, 2017

Study Completion

May 1, 2018

Last Updated

August 9, 2018

Record last verified: 2018-08

Locations

GB(11)