Clinical Trial: Clinical Tolerance to a Live Attenuated Vaccine Against Influenza (Flumist®) in a Population Allergic to Eggs
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: 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
Brief Summary: 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.
Detailed Summary:
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.
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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
Sponsor: St. Justine's Hospital
Current Primary Outcome: Anaphylactic reaction following the administration of the vaccine [ Time Frame: Observation period at hospital during one hour post vaccination. And Follow-up phone call 24 hours post vacciation. ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Allergic reactions occuring in the 24 hours following the immunization with Flumist. [ Time Frame: Datas will be assessed following the period of immunization. 24 hours following the immunization ]
Original Secondary Outcome: Same as current
Information By: St. Justine's Hospital
Dates:
Date Received: October 25, 2013
Date Started: November 2013
Date Completion:
Last Updated: May 19, 2014
Last Verified: May 2014
