Efficacy & Safety of Nasal Influenza Immunisation in Children - The SNIFFLE-3 Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Vaccine Efficacy
研究概览
简要总结
The UK Departments of Health now recommend annual influenza vaccination for all children 2-7 years of age, with children over 7 years eligible for vaccination if in certain higher risk clinical categories. Though data are available documenting the safety and immunogenicity of LAIV in this age group, there are little data to assess efficacy and immune correlates in UK children, and in particular atopic children. This study will enrol 200 children (and at least 200 unvaccinated household sibling controls), many with a history of asthma or recurrent wheezing, and allow an assessment of efficacy, safety and immune correlates in these children, and how this varies with prior administration of pandemic influenza vaccine and/or LAIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 2 - 18 years old
- •Written informed consent from parent/guardian (or patient themselves from age 16 years), with assent from children aged 8 years and above wherever possible.
排除标准
- •Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue) [notwithstanding allergy to egg protein]
- •Previous systemic allergic reaction to LAIV
- •Previous allergic reaction to an influenza vaccine (not LAIV) is a relative contra-indication, which must be discussed with the site PI to confirm patient suitability
- •Children/adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids**.
- •**High-dose steroids is defined as a treatment course for at least one month, equivalent to a dose of prednisolone at 20mg or more per day (any age); or for children under 20kg, a dose of 1mg/kg/day or more.
- •Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection.
- •pregnancy
- •Febrile ≥ 38.0 'C in last 72 hours
- •Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child's treating healthcare professional
- •Recent admission to hospital in last 2 weeks for acute asthma
- •Current oral steroid for asthma exacerbation or course completed within last 2 weeks
- •Received any blood or blood products within the past 12 weeks
- •Any other significant condition or circumstance which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
研究组 & 干预措施
Intervention
Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness.
干预措施: Live attenuated influenza vaccine (Drug)
Intervention
Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness.
干预措施: Surveillance (nasal swabbing) during influenza season (Procedure)
Controls
Surveillance in siblings of participants in the Intervention arm, through nasal swabbing in the event of influenza-like illness, irrespective of their vaccination status.
干预措施: Surveillance (nasal swabbing) during influenza season (Procedure)
结局指标
主要结局
Vaccine Efficacy
时间窗: During 2015/2016 influenza season - precise dates to be set by Public Health England as this varies annually. Approximate duration of 3 months
Vaccine efficacy will be assessed through documentation of the incidence of laboratory confirmed influenza and other respiratory viruses in the children receiving LAIV compared to unvaccinated sibling controls
次要结局
- Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Those Received LAIV(Up to 1 month after LAIV administration)
- Immune Response to LAIV(Up to 6 weeks following administration of a single dose of LAIV)