In 2013, the NHS started a vaccination programme in some regions of England to provide free flu vaccines to children aged 2 years or older, and younger than 16 years. The programme has since been rolled out across England. Most children are given a vaccine that is sprayed into their nose.
In clinical trials, this vaccine has been shown to protect children from experiencing severe flu symptoms. It is important to describe how it is used, and what happens to children who receive it in the wider community. This evidence will help the NHS to check that the vaccine roll out runs as planned and produces the intended benefits.
This study aims to: (1) describe how many children each year receive flu vaccines, and describe the characteristics of children who are and aren’t vaccinated for influenza; (2) test how often children receiving the vaccine see their GP or a hospital doctor for symptoms related to flu, compared to those who don’t; and (3) to test what groups of children are more or less likely to receive a flu vaccine.
To answer these objectives, the study will use the Clinical Practice Research Datalink, linked to Hospital Episode Statistics and the Office for National Statistics database.
A Live Attenuated Influenza Vaccination (LAIV) has been offered to children through a rolling national programme in England since 2013. Previous observational studies identified trends in LAIV uptake that varied with demographic and clinical profiles.
The general aim of this study is to provide up-to-date epidemiological evidence on the uptake of the influenza vaccines, and influenza related HCRU outcomes in children in England. The specific study objectives are given below.
Primary objective:
1.1 To estimate the uptake of the LAIV and Quadrivalent Influenza Vaccination (QIV), and influenza vaccinations where product not specified (NOS), between 2012- 2020 in children aged ≥2 and ≤17 years in England.
Secondary objectives:
2.1 Describe usage patterns of LAIV in England between 2012- 2020.
2.2 Describe and compare sociodemographic and clinical characteristics of the children vaccinated by LAIV and unvaccinated children each influenza season and evaluation the association between these characteristics and LAIV uptake in each season and across all seasons when eligible.
2.3 To describe the HCRU associated with laboratory confirmed influenza and/or influenza-like-illness (ILI) in the influenza season between 2012- 2020 overall and by LAIV vaccination status, and compare HCRU between unvaccinated, LAIV vaccinated and QIV vaccinated children in each influenza season
The study will include all research eligible aged ≥2 and ≤17 years in the study period, with ≥6 months of history in CPRD before their first influenza vaccination. It will use the CPRD data (vaccinations, diagnoses, characteristics) linked to HES.
Logistic regression analyses will be used to test for factors associated with vaccine uptake, and outcomes between vaccinated and unvaccinated children.
The study will provide up-to-date epidemiological evidence on the uptake of LAIV and its impact on HCRU related to ILI in children in England. This may be used by the NHS for planning and evaluation of the childhood influenza vaccination programme.
Receipt of Live Attenuated Influenza Vaccination (LAIV); receipt of Quadrivalent Influenza Vaccination (QIV); receipt of influenza vaccinations not otherwise specified (NOS); age at influenza vaccination; sex; ethnicity; body mass index (BMI); geographical location (East of England, London, Midlands, North East and Yorkshire, North West, South East, South West);The location of vaccine administration (healthcare provider; GP or nurse appointment, or another location; e.g. School or pharmacy); Index of multiple deprivation (IMD); comorbidities (including chronic respiratory disease [inc. asthma], chronic liver disease, diabetes, chronic central nervous system [CNS] disease, immunosuppression, cystic fibrosis, congenital lung abnormalities, heart disease [significant congenital, valvular, and/or rheumatic heart disease], renal disease [glomerulonephritis, chronic or congenital kidney disease], sickle cell anaemia, white blood cell disorders, malignancy, lipid metabolism disorders, cerebral palsy, down syndrome); baseline GP consultation; baseline GP consultations for Influenza like Illness (ILI); baseline secondary HCRU including outpatient visits, inpatient admissions, A&E attendances; ILI-related HCRU during the influenza season including GP consultations, out of hours GP contact, number of in-person consultations, number of telehealth/virtual GP consultations, outpatient visits, inpatient admissions, length of stay for influenza and ILI, A&E attendances; Laboratory confirmed influenza infections; diagnosis of bronchitis, bronchiolitis or otitis media [CPRD or HES]; total antibiotic and antiviral prescriptions [CPRD]; Healthcare Resource Group (HRG).
Michael Watt - Chief Investigator - AstraZeneca Ltd - UK Headquarters
Nick Denholm - Corresponding Applicant - Harvey Walsh Ltd
Bethany Levick - Collaborator - Harvey Walsh Ltd
Chloe Middleton-Dalby - Collaborator - Harvey Walsh Ltd
Holly Chaignaud - Collaborator - Harvey Walsh Ltd
Mark McCormack - Collaborator - Harvey Walsh Ltd
Michelle Harley - Collaborator - AstraZeneca Ltd - UK Headquarters
Peter Stilwell - Collaborator - Harvey Walsh Ltd
Shruti Menon - Collaborator - AstraZeneca Ltd - UK Headquarters
Holly Chaignaud - Collaborator - Harvey Walsh Ltd
Michelle Harley - Collaborator - AstraZeneca Ltd - UK Headquarters
HES Accident and Emergency;HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Rural-Urban Classification