NCT01859039

Safety of Nasal Influenza Immunisation in Egg Allergic Children

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 282 (actual)
• Sponsor: University Hospital Southampton NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Egg Hypersensitivity

Interventions

Type	Name	Description
BIOLOGICAL	Administration of Live attenuated influenza vaccine

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-05-21
• Last updated: 2020-08-10

Locations

12 sites across 1 country: United Kingdom