EUCTR2015-003019-39-GB进行中（未招募）1 期
Efficacy & Safety of Nasal Influenza Immunisation in Children - The SNIFFLE-3 study - SNIFFLE-3 Study
未提供0 个研究点目标入组 276 人开始时间: 2015年7月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 276
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Aged 2 – 18 years.
- •2.Written informed consent from parent/guardian (or the patient themselves from age 16 years), with assent from children aged 8 years and above wherever possible.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 200
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Contraindications to LAIV (notwithstanding allergy to egg protein), which include:
- •a.Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue)
- •b.Previous systemic allergic reaction to LAIV
- •c.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
- •d.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.
- •NB: LAIV is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled/low-dose oral systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.
- •e.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.
- •f.pregnancy
- •2.Contraindication to vaccination on that occasion, e.g. due to child being acutely unwell:
- •a.Febrile =38.0oC in last 72 hours
- •b.Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child’s treating healthcare professional
- •c.Recent admission to hospital in last 2 weeks for acute asthma
- •d.Current oral steroid for asthma exacerbation or course completed within last 2 weeks
- •e.Received any blood or blood products within the past 12 weeks
- •f.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.
- •Recent antihistamine use is not a contra-indication to LAIV administration, but use of any antihistamine in the 96 hours prior to LAIV will be logged on the CRF.
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