Uptake of the Childhood Live Attenuated Influenza Vaccine (LAIV) and Influenza-related Healthcare Resource Use in England During the 2012 to 2022 Flu Seasons; a Retrospective, Observational Study in the CPRD and HES Databases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 12,775,880
- 试验地点
- 1
- 主要终点
- Uptake of influenza vaccination
研究概览
简要总结
In 2013, the NHS started a vaccination program in some regions of England to provide free flu vaccines to children aged 2 years or older, and younger than 16 years. The program 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.
详细描述
A Live Attenuated Influenza Vaccination (LAIV) has been offered to children through a rolling national program 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:
- To evaluate the uptake of influenza vaccines in children aged ≥2 and <18 years in England between 2012 and 2020 for LAIV, QIV, and influenza vaccinations where the product is not specified
Secondary objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥6 months and <2 years on the 1st September
- •Have a high-risk condition as listed in the Green Book.
排除标准
- •Were deceased or had migrated out of their practice prior to the 1st September in the current influenza season.
- •Were recorded has receiving both QIV and LAIV in the current influenza season.
结局指标
主要结局
Uptake of influenza vaccination
时间窗: Per flu season (defined as 1st September in a given year to the 30th April the following year )
Proportion of eligible individuals receiving a flu vaccine (LAIV, QIV, other)
次要结局
- Admitted Patient Care (APC) episodes associated with ILI(From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).)
- Outpatient attendances associated with ILI(From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).)
- Length of stay in APC for influenza and ILI(From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).)
- GP consultations for ILI (influenza-like illness)(From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).)
- Accident and Emergency (A&E) attendances associated with ILI(From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).)
- Number of antiviral prescriptions(From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).)
- Laboratory confirmed influenza(From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).)
- Number of antibiotic prescriptions(From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).)