Pilot Project on Clinical Tolerance to a Live Attenuated Vaccine Against Influenza (Flumist®) in the Context of Influenza Vaccination in a Population Allergic to Eggs.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Anaphylactic reaction following the administration of the vaccine
研究概览
简要总结
The objective of this study is to verify the clinical tolerance to the vaccine Flumist (intranasal live attenuated influenza vaccine) in a population of egg allergic children. More specifically, the investigators want to estimate the risk of severe allergic reaction arising within 24 hours following the vaccination of egg allergic with Flumist.
详细描述
TITLE: Clinical tolerance of a live, attenuated influenza vaccine (FluMist®) in the context of influenza immunization in a population of egg-allergic children: A pilot project. Protocol #: FluMist240713.
- INTRODUCTION
In Canada, the flu vaccine is indicated for all children between 6 and 23 months of age. Epidemiologic and clinical studies have demonstrated that these children have a higher risk of complication and a higher rate of hospitalisation due to influenza. Trivalent inactivated influenza vaccines (TIV), which are administered intramuscularly, have long been used for preventative vaccination in this population. FluMist® is a live attenuated influenza vaccine (LAIV) administrated intranasally, which has been approved for use in Canada since 2010[1 ]. Besides avoiding the inconvenience and the anxiety related to intramuscular vaccines, FluMist® offers a better protection against influenza than the TIV. The Canadian National Advisory Committee on Immunization (NACI) recommends the preferential use of LAIV over TIV for influenza immunization in children 24 months old and over. Furthermore, LAIV use is favoured for children with chronic disease and those suffering from non-severe asthma [ 2].
The influenza vaccine is manufactured using chicken egg embryos and as such, contains minimal residual quantities of ovalbumin (egg protein). In patients with an egg allergy, numerous clinical studies have demonstrated that its administration is safe with very little risk of anaphylactic reaction. Therefore, egg allergy is no longer a contra-indication to receiving TIV and these patients can now receive this vaccine without further precautions in CLSCs and doctors' offices[3 ,4 ]. There are no studies on the safety of LAIV administration in egg-allergic patients. As egg-allergic patients often have other atopic related comorbidities such as asthma, the increased protection against influenza which can be achieved with LAIV is desirable. The egg protein content in LAIV is comparable to that in TIV and its administration is intranasal rather than systemic. Therefore, it is reasonable to hypothesize that LAIV administration in egg-allergic patients is as safe as TIV administration in this same population. Yet, before recommending LAIV in egg-allergic patients, a study on its safety in this population is essential.
1.1 Use of eggs in the production of influenza vaccines
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Egg allergic children
排除标准
- •Uncontrolled asthma the day of immunization
- •severe asthma treated by oral steroids or high dose of inhaled steroids
- •urticaria on the day of immunization
- •antihistamines taken in the previous 3 to 7 days of immunization
- •acute disease on the day of immunization (fever,irritability, vomiting, diarrhea, pallor, cyanosis, diaphoresis, lethargy)
- •immunosuppressed patients or health worker who should be in contact with immunosuppressed patients.
结局指标
主要结局
Anaphylactic reaction following the administration of the vaccine
时间窗: Observation period at hospital during one hour post vaccination. And Follow-up phone call 24 hours post vacciation.
次要结局
- Allergic reactions occuring in the 24 hours following the immunization with Flumist.(Datas will be assessed following the period of immunization. 24 hours following the immunization)
研究者
Dr. Anne Des Roches
M.D., Allergist
St. Justine's Hospital