EUCTR2014-001537-92-GB进行中（未招募）不适用
Safety of Nasal Influenza Immunisation in Egg Allergic Children - The SNIFFLE 2 study - SNIFFLE 2 Study
niversity Hospital Southampton NHS Foundation Trust0 个研究点目标入组 730 人开始时间: 2014年5月13日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 730
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
- 性别
- All
入选标准
- •1.Aged 2 – 17 years old
- •2.Physician-diagnosis of egg allergy WITH current avoidance of egg in one of the following categories:
- •E0 – avoids all foods containing egg in any form
- •E1 – tolerates egg in baked foods (cakes, biscuits) but not other forms
- •E2 – able to eat lightly cooked egg (e.g. scrambled egg, boiled egg) but reacts to raw egg in uncooked cake mixtures, fresh mayonnaise, ice cream etc.
- •3.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: 730
- •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.Clinical resolution of egg allergy
- •2.Contraindications to LAIV (notwithstanding allergy to egg protein):
- •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. NB: LAIV is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled corticosteroids or low-dose 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.
- •3.Contraindication to vaccination on that occasion, 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
研究者
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