Influenza Vaccines Efficacy and SafetyPhase 4SNIFFLE-3NCT02549365
Efficacy & Safety of Nasal Influenza Immunisation in Children
A Phase 4 study testing Live attenuated influenza vaccine and Surveillance (nasal swabbing) during influenza season in people with Influenza Vaccines Efficacy and Safety, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccines Efficacy and Safety
- What is being tested?
- Live attenuated influenza vaccine and Surveillance (nasal swabbing) during influenza season
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Apr 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College London / Imperial College Healthcare NHS Trust
London, W2 1NY
About this study
Official title: Efficacy & Safety of Nasal Influenza Immunisation in Children - The SNIFFLE-3 Study
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
- Being tested
- Live attenuated influenza vaccine, Surveillance (nasal swabbing) during influenza season
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live attenuated influenza vaccineDrug
Also called Fluenz, Flumist
Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season
Surveillance (nasal swabbing) during influenza seasonProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Surveillance (nasal swabbing) during influenza season |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
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)
Measured: Up to 1 month after LAIV administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Influenza Vaccines Efficacy and SafetyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health England
- Responsible party
- Sponsor
- Investigators
- Paul J Turner, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549365
- Sponsor's protocol ID
- 15SM2801
- Other IDs
- 2015-003019-39, 2015
- Acronym
- SNIFFLE-3
- Status last verified
- Dec 2019
- First submitted
- 8 Sep 2015
- Last updated
- 11 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy & Safety of Nasal Influenza Immunisation in Children - The SNIFFLE-3 Study
- ClinicalTrials.gov ID
- NCT02549365
- Acronym / sponsor ID
- SNIFFLE-3 / 15SM2801
- Conditions
- Influenza Vaccines Efficacy and Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Public Health England
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Posted 27 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Live attenuated influenza vaccine, Procedure: Surveillance (nasal swabbing) during influenza seasonAdministration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness. |
| Controls | Other | Procedure: Surveillance (nasal swabbing) during influenza seasonSurveillance in siblings of participants in the Intervention arm, through nasal swabbing in the event of influenza-like illness, irrespective of their vaccination status. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live attenuated influenza vaccineAlso: Fluenz, FlumistAdministration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season | Drug | Intervention |
| Surveillance (nasal swabbing) during influenza season | Procedure or surgery | Controls, Intervention |
Primary outcome
Vaccine Efficacy
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
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
2 secondary outcomes
Immune Response to LAIV
Time frame: 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
Time frame: Up to 1 month after LAIV administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul J Turner principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Live attenuated influenza vaccine and Surveillance (nasal swabbing) during influenza season in people with Influenza Vaccines Efficacy and Safety, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine Efficacy (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.