Efficacy & Safety of Nasal Influenza Immunisation in Children

NCT02549365 | Completed Phase 4 Results DMC

• 2 other identifiers: 15SM28012015-003019-39
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Vaccine Efficacy

  Vaccine efficacy will be assessed through documentation of the incidence of laboratory confirmed influenza and other respiratory viruses in the children receiving LAIV compared to unvaccinated sibling controls

  During 2015/2016 influenza season - precise dates to be set by Public Health England as this varies annually. Approximate duration of 3 months

Secondary Outcomes (2)

• Immune Response to LAIV

  Up to 6 weeks following administration of a single dose of LAIV

• Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Those Received LAIV

  Up to 1 month after LAIV administration

Study Arms (2)

Intervention

EXPERIMENTAL

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

Drug: Live attenuated influenza vaccine; Procedure: Surveillance (nasal swabbing) during influenza season

Controls

OTHER

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

Procedure: Surveillance (nasal swabbing) during influenza season

Interventions

Live attenuated influenza vaccine DRUG

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

Also known as: Fluenz, Flumist

Intervention

Surveillance (nasal swabbing) during influenza season PROCEDURE

Controls; Intervention

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead
• Public Health England: collaborator

Study Sites (1)

Imperial College London / Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

MeSH Terms

Interventions

Influenza Vaccines; FluMist

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr Paul Turner
• Organization: Imperial College London

p.turner@imperial.ac.uk

+44 20 3312 7754

Study Officials

• Paul J Turner

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: September 15, 2015
• Study Start: October 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: December 11, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-12

Locations

GB (1)