Phase 4 Study to Assess the Safety of Nasal Influenza Immunisation in Egg Allergic Children - a Multicentre Observational Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 779
- 试验地点
- 29
- 主要终点
- Incidence of allergic reaction to nasal influenza vaccination using a Live Attenuated Influenza Vaccine (LAIV) in egg-allergic children
研究概览
简要总结
Egg allergy is common in early childhood, affecting at least one in 50 preschool children. Influenza ("'flu") vaccines contain egg protein, as the vaccine is cultured in hen's eggs. There is robust data to support the safety of influenza vaccines (containing low or negligible amounts of egg protein) in patients with egg allergy.
A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently been approved by a number of licensing boards and is given by a spray into the nose. This new vaccine has been available in the United States for several years and is highly effective and against influenza infection, with an excellent safety profile in children without egg allergy. However, LAIV is also grown in hen's eggs and contains egg protein, and there are NO published data on the safety of LAIV in egg-allergic children. In SNIFFLE 1 Study, 433 doses were given to 282 egg-allergic children; data is currently being analysed.
The objective of this multicentre study is to further assess the safety of intranasal LAIV in egg-allergic children, in order to demonstrate that these children can safely be given the new LAIV within a primary care health environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 2 - 17 years old
- •Physician-diagnosis of egg allergy
排除标准
- •Clinical resolution of egg allergy
- •Contraindications to LAIV (notwithstanding allergy to egg protein):
- •Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue)
- •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. 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.
- •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.
- •Contraindication to vaccination on that occasion, due to child being acutely unwell:
- •Febrile ≥38.0oC 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
研究组 & 干预措施
Egg allergic children
Children with a physician diagnosis of egg allergy will be recruited to receive the intranasal LAIV as part of a safety surveillance study
干预措施: Administration of Live attenuated influenza vaccine (LAIV) (Drug)
结局指标
主要结局
Incidence of allergic reaction to nasal influenza vaccination using a Live Attenuated Influenza Vaccine (LAIV) in egg-allergic children
时间窗: Within 2 hours of vaccine administration
次要结局
- Asthma control test(4 weeks post LAIV)
- Incidence of delayed symptoms up to 72 hours after nasal influenza vaccination with LAIV in egg-allergic children(72 hours after vaccine administration)
研究者
Paul Turner
MRC Clinician Scientist
Imperial College London