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
- 不适用
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 12
- 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 existing data on the safety of LAIV in egg-allergic children.
The objective of this multicentre study is to 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
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Contraindicated as acutely unwell or current unstable asthma
- •Use of asthma reliever medication in last 72 hours
- •Recent administration of a medication containing antihistamine within the last 4 days
- •Current oral steroid for asthma exacerbation or course completed within last 2 weeks
- •Contraindications to ingredient in LAIV (notwithstanding allergy to egg protein)
- •Previous allergic reaction to an influenza vaccine
- •Children and 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.
- •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.
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
- 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 in Paediatric Allergy & Immunology
Imperial College London