Efficacy & Safety of Nasal Influenza Immunisation in Children

NCT ID: NCT02549365

Last Updated: 2019-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-04-30

Brief Summary

The UK Departments of Health now recommend annual influenza vaccination for all children 2-7 years of age, with children over 7 years eligible for vaccination if in certain higher risk clinical categories. Though data are available documenting the safety and immunogenicity of LAIV in this age group, there are little data to assess efficacy and immune correlates in UK children, and in particular atopic children. This study will enrol 200 children (and at least 200 unvaccinated household sibling controls), many with a history of asthma or recurrent wheezing, and allow an assessment of efficacy, safety and immune correlates in these children, and how this varies with prior administration of pandemic influenza vaccine and/or LAIV.

Conditions

Influenza Vaccines Efficacy and Safety

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness.

Group Type: EXPERIMENTAL

Live attenuated influenza vaccine

Intervention Type: DRUG

Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season

Surveillance (nasal swabbing) during influenza season

Intervention Type: PROCEDURE

Controls

Surveillance in siblings of participants in the Intervention arm, through nasal swabbing in the event of influenza-like illness, irrespective of their vaccination status.

Group Type: OTHER

Surveillance (nasal swabbing) during influenza season

Intervention Type: PROCEDURE

Interventions

Live attenuated influenza vaccine

Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season

Intervention Type: DRUG

Surveillance (nasal swabbing) during influenza season

Intervention Type: PROCEDURE

Other Intervention Names

Fluenz; Flumist

Eligibility Criteria

Inclusion Criteria

• Aged 2 - 18 years old
• Written informed consent from parent/guardian (or patient themselves from age 16 years), with assent from children aged 8 years and above wherever possible.

Exclusion Criteria

• Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue) [notwithstanding allergy to egg protein]
• Previous systemic allergic reaction to LAIV
• Previous allergic reaction to an influenza vaccine (not LAIV) is a relative contra-indication, which must be discussed with the site PI to confirm patient suitability
• Children/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**.

**High-dose steroids is defined as a treatment course for at least one month, equivalent to a dose of prednisolone at 20mg or more per day (any age); or for children under 20kg, a dose of 1mg/kg/day or more.

• 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.
• pregnancy
• Febrile ≥ 38.0 'C in last 72 hours
• Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child's treating healthcare professional
• Recent admission to hospital in last 2 weeks for acute asthma
• Current oral steroid for asthma exacerbation or course completed within last 2 weeks
• Received any blood or blood products within the past 12 weeks
• Any other significant condition or circumstance which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Public Health England

OTHER_GOV

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul J Turner

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Imperial College London / Imperial College Healthcare NHS Trust

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

2015-003019-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15SM2801

Identifier Type: -

Identifier Source: org_study_id