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Childhood Influenza Immunisation Invitation Trial in Schools

Can Uptake of Childhood Influenza Immunisation Through Schools be Increased Through Behavioural-insight Informed Changes to the Invitation Process?

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02883972
Enrollment
0
Registered
2016-08-30
Start date
2016-09-30
Completion date
2017-04-30
Last updated
2023-04-25

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

Conditions

Influenza, Human

Keywords

Immunization, Behavioural insights, Children

Brief summary

This study will investigate whether influenza vaccine uptake by school-age children (in school-based clinics) can be increased by making behavioural-insight informed changes to the invitation process which encourage parents to return consent forms.

Detailed description

Previous research has shown that small changes to the invitation phrasing and/or process informed by understanding and insights into behaviour can be used to increase a desired behaviour (e.g. uptake of health checks, reducing primary care antibiotic prescribing). This trial will determine whether a behaviour-insight informed invitation letter and/or reminder Short Message Service (SMS)/email message can increase return of consent forms and thereby increase uptake of childhood flu vaccine in schools. The trial will take place within the existing national childhood immunisation programme in participating areas in England. Randomisation will be at the school-level (stratified by local authority). All eligible children within a school will therefore be in the same arm of the trial and be subject to the same invitation process. Outcome data will be routinely collected, school-level influenza vaccine uptake data. Data will also be collected on the implementation of email/SMS reminders in all schools. The analysis will investigate the main effects of the interventions and their interactions, take into account provider, local authority and school effects and explore the impact of other factors such as deprivation indicators. An analysis of letters used by providers of childhood influenza immunisation in schools not involved in the trial will also be conducted. All providers will be asked to submit a copy of their invitation letter for the 2016/17 programme and these will be analysed using the Theoretical Domains Framework.

Interventions

Behavioural-insight informed letter template

Invitation letter used by local area last year (updated as required)

OTHERReminder

Behavioural-insight informed SMS/email reminder message to return consent form

Sponsors

Public Health England
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
Yes

Inclusion criteria

* Attendance at a school where national childhood influenza immunisation programme is delivered by a provider participating in the trial * Eligible for influenza immunisation

Exclusion criteria

* Ineligible for influenza immunisation

Design outcomes

Primary

MeasureTime frameDescription
Influenza immunisation uptake in school years 1-35 monthsProportion of children in school years 1-3 who receive influenza immunisation as part of the national childhood immunisation programme

Secondary

MeasureTime frameDescription
Influenza immunisation uptake in Reception school year5 monthsProportion of children in Reception school year who receive influenza immunisation
Influenza immunisation uptake in each school year5 monthsProportion of children in each school year who receive influenza immunisation
Influenza immunisation uptake in school years 4-65 monthsProportion of children in school years 4-6 who receive influenza immunisation
Influenza immunisation consent in school years 4-65 monthsProportion of children in school years 4-6 for who consent is neither given nor withheld (i.e. non-responders)
Influenza immunisation consent in Reception school year5 monthsProportion of children in Reception school year for who consent is neither given nor withheld (i.e. non-responders)
Influenza immunisation consent in school years 1-35 monthsProportion of children in school years 1-3 for who consent is neither given nor withheld (i.e. non-responders)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026