Clinical Trial: Safety of Nasal Influenza Immunisation in Egg Allergic Children - The SNIFFLE 2 Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 4 Study to Assess the Safety of Nasal Influenza Immunisation in Egg Allergic Children - a Multicentre Observational Study

Brief 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.

Detailed Summary:
Sponsor: Imperial College London

Current Primary Outcome: Incidence of allergic reaction to nasal influenza vaccination using a Live Attenuated Influenza Vaccine (LAIV) in egg-allergic children [ Time Frame: Within 2 hours of vaccine administration ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Incidence of delayed symptoms up to 72 hours after nasal influenza vaccination with LAIV in egg-allergic children [ Time Frame: 72 hours after vaccine administration ]
• Asthma control test [ Time Frame: 4 weeks post LAIV ]
  To assess for a change in asthma control (by validated questionnaire) pre and 4 weeks post LAIV immunisation.

Original Secondary Outcome: Incidence of delayed symptoms up to 72 hours after nasal influenza vaccination with LAIV in egg-allergic children [ Time Frame: 72 hours after vaccine administration ]

Information By: Imperial College London

Dates:
Date Received: April 4, 2014
Date Started: September 2014
Date Completion:
Last Updated: May 27, 2015
Last Verified: May 2015