Safety of Nasal Influenza Immunisation in Egg Allergic Children (SNIFFLE)

University Hospital Southampton NHS Foundation Trust

Status: Completed

Conditions: Egg Hypersensitivity

Treatments: Biological: Administration of Live attenuated influenza vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT01859039

RHM CHI 0659

Details and patient eligibility

About

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.

Enrollment: 282 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 2 - 17 years old
• Physician-diagnosis of egg allergy

Exclusion criteria

• Contraindicated as acutely unwell or current unstable asthma
• Use of asthma reliever medication in last 72 hours
• Recent administration of a medication containing antihistamine within the last 4 days
• Current oral steroid for asthma exacerbation or course completed within last 2 weeks
• Contraindications to ingredient in LAIV (notwithstanding allergy to egg protein)
• Previous allergic reaction to an influenza vaccine
• Children and adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids.
• Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection.

Trial design

282 participants in 1 patient group

Egg allergic children

Description:

Administration of Live attenuated influenza vaccine

Treatment:

Biological: Administration of Live attenuated influenza vaccine