Safety of Nasal Influenza Immunisation in Egg Allergic Children - The SNIFFLE 2 Study
Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Imperial College London University Hospital Southampton NHS Foundation Trust
Collaborators:
Imperial College London Public Health England University Hospital Southampton NHS Foundation Trust