NCT02921633

Brief Summary

This study will investigate whether behaviourally informed changes to the invitation process can improve uptake of childhood influenza vaccine by two and three year olds at primary care.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
21,786

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

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 27, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 29, 2019

Status Verified

September 1, 2016

Enrollment Period

5 months

First QC Date

September 27, 2016

Last Update Submit

August 27, 2019

Conditions

Influenza, Human

Keywords

ImmunizationBehavioural insightsChildren

Outcome Measures

Primary Outcomes (1)

  • Influenza immunisation uptake

    Immunisation uptake by eligible children (i.e. those aged 2 and 3 years on 31st August 2016) at primary care. Individual immunisation uptake data are routinely sent by primary care practices to the Child Health Information System. Anonymised uptake data will therefore be extracted for all eligible children from this system.

    4 months

Study Arms (2)

Intervention letter

EXPERIMENTAL

Centrally-sent behavioural-insight informed invitation letter.

Other: Intervention letter

Control

NO INTERVENTION

No centrally-sent invitation letter.

Interventions

Intervention letterOTHER
Intervention letter

Eligibility Criteria

Age2 Years - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years or 3 year olds at 31st August 2016
  • Registered with a primary care practice in the participating area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Howell-Jones R, Gold N, Bowen S, Bunten A, Tan K, Saei A, Jones S, MacDonald P, Watson R, Bennett KF, Chadborn T. Can uptake of childhood influenza immunisation through schools and GP practices be increased through behaviourally-informed invitation letters and reminders: two pragmatic randomized controlled trials. BMC Public Health. 2023 Jan 20;23(1):143. doi: 10.1186/s12889-022-14439-4.

    PMID: 36670376DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Tim Chadborn, BSc MSc PhD

    Public Health England

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

October 3, 2016

Study Start

October 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

August 29, 2019

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share