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Childhood Influenza Immunisation Invitation Trial in Schools

Primary Purpose

Influenza, Human

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention letter
Control letter
Reminder
Sponsored by
Public Health England
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Influenza, Human focused on measuring Immunization, Behavioural insights, Children

Eligibility Criteria

4 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Intervention letter and reminder

    Intervention letter

    Control letter and reminder

    Control letter

    Arm Description

    Behavioural insights informed invitation letter and SMS/email reminder message

    Behavioural insights informed invitation letter only

    Control invitation letter and SMS/email reminder message

    Control invitation letter only

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    July 22, 2016
    Last Updated
    April 21, 2023
    Sponsor
    Public Health England
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02883972
    Brief Title
    Childhood Influenza Immunisation Invitation Trial in Schools
    Official Title
    Can Uptake of Childhood Influenza Immunisation Through Schools be Increased Through Behavioural-insight Informed Changes to the Invitation Process?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Ethical approval was withdrawn by the National Research Ethics Service as they were unable to make contact with the research team despite trying many times.
    Study Start Date
    September 2016 (Actual)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    April 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Public Health England

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Influenza, Human
    Keywords
    Immunization, Behavioural insights, Children

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention letter and reminder
    Arm Type
    Experimental
    Arm Description
    Behavioural insights informed invitation letter and SMS/email reminder message
    Arm Title
    Intervention letter
    Arm Type
    Experimental
    Arm Description
    Behavioural insights informed invitation letter only
    Arm Title
    Control letter and reminder
    Arm Type
    Experimental
    Arm Description
    Control invitation letter and SMS/email reminder message
    Arm Title
    Control letter
    Arm Type
    Active Comparator
    Arm Description
    Control invitation letter only
    Intervention Type
    Other
    Intervention Name(s)
    Intervention letter
    Intervention Description
    Behavioural-insight informed letter template
    Intervention Type
    Other
    Intervention Name(s)
    Control letter
    Intervention Description
    Invitation letter used by local area last year (updated as required)
    Intervention Type
    Other
    Intervention Name(s)
    Reminder
    Intervention Description
    Behavioural-insight informed SMS/email reminder message to return consent form
    Primary Outcome Measure Information:
    Title
    Influenza immunisation uptake in school years 1-3
    Description
    Proportion of children in school years 1-3 who receive influenza immunisation as part of the national childhood immunisation programme
    Time Frame
    5 months
    Secondary Outcome Measure Information:
    Title
    Influenza immunisation uptake in school years 4-6
    Description
    Proportion of children in school years 4-6 who receive influenza immunisation
    Time Frame
    5 months
    Title
    Influenza immunisation uptake in Reception school year
    Description
    Proportion of children in Reception school year who receive influenza immunisation
    Time Frame
    5 months
    Title
    Influenza immunisation uptake in each school year
    Description
    Proportion of children in each school year who receive influenza immunisation
    Time Frame
    5 months
    Title
    Influenza immunisation consent in school years 1-3
    Description
    Proportion of children in school years 1-3 for who consent is neither given nor withheld (i.e. non-responders)
    Time Frame
    5 months
    Title
    Influenza immunisation consent in school years 4-6
    Description
    Proportion of children in school years 4-6 for who consent is neither given nor withheld (i.e. non-responders)
    Time Frame
    5 months
    Title
    Influenza immunisation consent in Reception school year
    Description
    Proportion of children in Reception school year for who consent is neither given nor withheld (i.e. non-responders)
    Time Frame
    5 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tim Chadborn, BSc MSc PhD
    Organizational Affiliation
    Public Health England
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Childhood Influenza Immunisation Invitation Trial in Schools

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