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Efficacy & Safety of Nasal Influenza Immunisation in Children (SNIFFLE-3)

Primary Purpose

Influenza Vaccines Efficacy and Safety

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Live attenuated influenza vaccine
Surveillance (nasal swabbing) during influenza season
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza Vaccines Efficacy and Safety

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Imperial College London / Imperial College Healthcare NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Controls

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Immune Response to LAIV
To assess the immune response to vaccine and non-vaccine influenza strains before and after a single dose of LAIV administration, with respect to i. serological measures (haemagglutination inhibition titre to specific influenza strain) ii. change in specific nasal IgA responses
Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Those Received LAIV
Incidence of adverse events (AE) and serious adverse events (SAEs) in children receiving LAIV, with the following sub-analyses: AEs occurring up to 72 hours after LAIV in participants with a history of atopy / asthma / recurrent wheezing, compared to non-atopic participants. Wheezing / asthma symptoms in subjects given LAIV who have a past medical history of asthma or recurrent wheeze in the 4 weeks prior to vaccine administration vs the 3-4 week period after LAIV. NB: AE data was NOT collected in household controls, as per protocol NB: AE delay not collected in Controls (as per protocol)

Full Information

First Posted
September 8, 2015
Last Updated
December 4, 2019
Sponsor
Imperial College London
Collaborators
Public Health England
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1. Study Identification

Unique Protocol Identification Number
NCT02549365
Brief Title
Efficacy & Safety of Nasal Influenza Immunisation in Children
Acronym
SNIFFLE-3
Official Title
Efficacy & Safety of Nasal Influenza Immunisation in Children - The SNIFFLE-3 Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Public Health England

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Vaccines Efficacy and Safety

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
276 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness.
Arm Title
Controls
Arm Type
Other
Arm Description
Surveillance in siblings of participants in the Intervention arm, through nasal swabbing in the event of influenza-like illness, irrespective of their vaccination status.
Intervention Type
Drug
Intervention Name(s)
Live attenuated influenza vaccine
Other Intervention Name(s)
Fluenz, Flumist
Intervention Description
Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season
Intervention Type
Procedure
Intervention Name(s)
Surveillance (nasal swabbing) during influenza season
Primary Outcome Measure Information:
Title
Vaccine Efficacy
Description
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
Time Frame
During 2015/2016 influenza season - precise dates to be set by Public Health England as this varies annually. Approximate duration of 3 months
Secondary Outcome Measure Information:
Title
Immune Response to LAIV
Description
To assess the immune response to vaccine and non-vaccine influenza strains before and after a single dose of LAIV administration, with respect to i. serological measures (haemagglutination inhibition titre to specific influenza strain) ii. change in specific nasal IgA responses
Time Frame
Up to 6 weeks following administration of a single dose of LAIV
Title
Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Those Received LAIV
Description
Incidence of adverse events (AE) and serious adverse events (SAEs) in children receiving LAIV, with the following sub-analyses: AEs occurring up to 72 hours after LAIV in participants with a history of atopy / asthma / recurrent wheezing, compared to non-atopic participants. Wheezing / asthma symptoms in subjects given LAIV who have a past medical history of asthma or recurrent wheeze in the 4 weeks prior to vaccine administration vs the 3-4 week period after LAIV. NB: AE data was NOT collected in household controls, as per protocol NB: AE delay not collected in Controls (as per protocol)
Time Frame
Up to 1 month after LAIV administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Turner
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College London / Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

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Efficacy & Safety of Nasal Influenza Immunisation in Children

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