Influenza VaccinesPhase 4FluSHED-2NCT03735147
Assessment of Viral Shedding Week Following Administration of Live Attenuated Influenza Vaccine in Children
A Phase 4 study testing Live attenuated influenza vaccine (LAIV) in people with Influenza Vaccines, run by Imperial College London at 1 site in United Kingdom.
Trial summary
LAIV shedding studies in children could be an important way to confirm whether impediments to viral replication do indeed explain these observed reductions in vaccine effectiveness (VE), whether prior vaccination has any influence on replication and what future implications (if any) this might have for the UK… Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccines
- What is being tested?
- Live attenuated influenza vaccine (LAIV)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Oct 2018to 1 Apr 2019
- 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 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children age 6 years to 15 years +364 days of age on enrolment
- Children eligible to receive LAIV in accordance with current UK vaccine policy
- Written informed consent given by parent/ guardian and assent from child
Who cannot join
- Contraindications to LAIV (notwithstanding allergy to egg protein), which include:
- Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue)
- 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 CI 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*.
- Children / 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.
Show all 9Show fewer
- Pregnancy (determined by history). Where this cannot be confirmed, a urine pregnancy test will be performed.
- High---dose steroids is defined as a treatment course for at least one month, equivalent to a dose greater than 20mg prednisolone per day (any age), or for children under 20kg, a dose greater than 1mg/kg/day.
- NB: LAIV is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled/low-dose oral systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust (St. Mary's Hospital)
London
About this study
Official title: Assessment of Viral Shedding Week Following Administration of Live Attenuated Influenza Vaccine in Children: FluSHED-2 Study
LAIV shedding studies in children could be an important way to confirm whether impediments to viral replication do indeed explain these observed reductions in vaccine effectiveness (VE), whether prior vaccination has any influence on replication and what future implications (if any) this might have for the UK paediatric LAIV programme. LAIV virus replication in children will be dependent on virological and host factors. The virus factors include replicative fitness of individual strains and the susceptibility to inhibition by other replicating strains (ability to compete). Host factors which may influence this include pre-existing specific immunity as a result of prior infection or previous vaccination (with either LAIV or IIV), and innate immune factors including mucosal immunity.
There is significant variability in shedding across viral subtypes in studies done to date, so there is a need to obtain local data in a small pilot observational study which will look in detail at virus shedding by sequential daily virus samples, something not possible on a larger scale. The data generated will inform future LAIV studies in the UK in terms of optimum time of sample collection for viral shedding studies, which are likely to be required on a regular basis, to supplement field studies of vaccine effectiveness.
This study will enrol up to 30 children that will allow these factors to be assessed. Both written informed consent from parent/ guardian and written assent from the child will be in place prior to any study procedure. All participants will have a baseline assessment of pre--existing influenza immunity (blood test, oral fluid collection and nasal swabs), followed by a single dose of LAIV. Parents will then be asked to take nasal swabs at home on days 1, 2, 3, 4, 5, 6, 7, 8, with further nasal swab, blood test and oral fluid collection in hospital 4 weeks later, in order to assess for immune responses to LAIV.
- Conditions
- Influenza Vaccines
- Being tested
- Live attenuated influenza vaccine (LAIV)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live attenuated influenza vaccine (LAIV)Biological
Also called Fluenz Tetra
Single dose of LAIV
| Study group | Role | What they receive |
|---|---|---|
| All children | Experimental | Administration of live attenuated influenza vaccine (LAIV) Receives: Biological: Live attenuated influenza vaccine (LAIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type-specific Vaccine Virus Shedding in 2018/19 - Day 1 Post LAIV
No of participants with viral shedding on day 1 following LAIV vaccination
Measured: Assessed on day 1 post LAIV
Type-specific Vaccine Virus Shedding in 2018/19 - Day 2 Post LAIV
No of participants with viral shedding on day 2 following LAIV vaccination
Measured: Assessed on day 2 post LAIV
Type-specific Vaccine Virus Shedding in 2018/19 - Day 3 Post LAIV
No of participants with viral shedding on day 3 following LAIV vaccination
Measured: Assessed on day 3 post LAIV
Type-specific Vaccine Virus Shedding in 2018/19 - Day 4 Post LAIV
No of participants with viral shedding on day 4 following LAIV vaccination
Measured: Assessed on day 4 post LAIV
Type-specific Vaccine Virus Shedding in 2018/19 - Day 5 Post LAIV
No of participants with viral shedding on day 5 following LAIV vaccination
Measured: Assessed on day 5 post LAIV
Type-specific Vaccine Virus Shedding in 2018/19 - Day 6 Post LAIV
No of participants with viral shedding on day 6 following LAIV vaccination
Measured: Assessed on day 6 post LAIV
Type-specific Vaccine Virus Shedding in 2018/19 - Day 7 Post LAIV
No of participants with viral shedding on day 7 following LAIV vaccination
Measured: Assessed on day 7 post LAIV
Type-specific Vaccine Virus Shedding in 2018/19 - Day 8 Post LAIV
No of participants with viral shedding on day 8 following LAIV vaccination
Measured: Assessed on day 8 post LAIV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start23 Oct 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
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 VaccinesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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, FRACP, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735147
- Sponsor's protocol ID
- 18SM4658
- Other IDs
- 2018-002470-42, 18/LO/1317, 2018
- Acronym
- FluSHED-2
- Status last verified
- Apr 2024
- First submitted
- 22 Oct 2018
- Last updated
- 5 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Viral Shedding Week Following Administration of Live Attenuated Influenza Vaccine in Children: FluSHED-2 Study
- ClinicalTrials.gov ID
- NCT03735147
- Acronym / sponsor ID
- FluSHED-2 / 18SM4658
- Conditions
- Influenza Vaccines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Public Health England
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Posted 5 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
LAIV shedding studies in children could be an important way to confirm whether impediments to viral replication do indeed explain these observed reductions in vaccine effectiveness (VE), whether prior vaccination has any influence on replication and what future implications (if any) this might have for the UK paediatric LAIV programme. LAIV virus replication in children will be dependent on virological and host factors. The virus factors include replicative fitness of individual strains and the susceptibility to inhibition by other replicating strains (ability to compete). Host factors which may influence this include pre-existing specific immunity as a result of prior infection or previous vaccination (with either LAIV or IIV), and innate immune factors including mucosal immunity.
There is significant variability in shedding across viral subtypes in studies done to date, so there is a need to obtain local data in a small pilot observational study which will look in detail at virus shedding by sequential daily virus samples, something not possible on a larger scale. The data generated will inform future LAIV studies in the UK in terms of optimum time of sample collection for viral shedding studies, which are likely to be required on a regular basis, to supplement field studies of vaccine effectiveness.
This study will enrol up to 30 children that will allow these factors to be assessed. Both written informed consent from parent/ guardian and written assent from the child will be in place prior to any study procedure. All participants will have a baseline assessment of pre--existing influenza immunity (blood test, oral fluid collection and nasal swabs), followed by a single dose of LAIV. Parents will then be asked to take nasal swabs at home on days 1, 2, 3, 4, 5, 6, 7, 8, with further nasal swab, blood test and oral fluid collection in hospital 4 weeks later, in order to assess for immune responses to LAIV.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All children | Experimental | Biological: Live attenuated influenza vaccine (LAIV)Administration of live attenuated influenza vaccine (LAIV) |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children age 6 years to 15 years +364 days of age on enrolment
- Children eligible to receive LAIV in accordance with current UK vaccine policy
- Written informed consent given by parent/ guardian and assent from child
Key exclusion criteria (9 listed)
- Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue)
- 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 CI 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*.
- Children / 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.
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 vaccine (LAIV)Also: Fluenz TetraSingle dose of LAIV | Biological | All children |
Primary outcome
Type-specific Vaccine Virus Shedding in 2018/19 - Day 1 Post LAIV
Time frame: Assessed on day 1 post LAIV
No of participants with viral shedding on day 1 following LAIV vaccination
Type-specific Vaccine Virus Shedding in 2018/19 - Day 2 Post LAIV
Time frame: Assessed on day 2 post LAIV
No of participants with viral shedding on day 2 following LAIV vaccination
Type-specific Vaccine Virus Shedding in 2018/19 - Day 3 Post LAIV
Time frame: Assessed on day 3 post LAIV
No of participants with viral shedding on day 3 following LAIV vaccination
Type-specific Vaccine Virus Shedding in 2018/19 - Day 4 Post LAIV
Time frame: Assessed on day 4 post LAIV
No of participants with viral shedding on day 4 following LAIV vaccination
Type-specific Vaccine Virus Shedding in 2018/19 - Day 5 Post LAIV
Time frame: Assessed on day 5 post LAIV
No of participants with viral shedding on day 5 following LAIV vaccination
Type-specific Vaccine Virus Shedding in 2018/19 - Day 6 Post LAIV
Time frame: Assessed on day 6 post LAIV
No of participants with viral shedding on day 6 following LAIV vaccination
Type-specific Vaccine Virus Shedding in 2018/19 - Day 7 Post LAIV
Time frame: Assessed on day 7 post LAIV
No of participants with viral shedding on day 7 following LAIV vaccination
Type-specific Vaccine Virus Shedding in 2018/19 - Day 8 Post LAIV
Time frame: Assessed on day 8 post LAIV
No of participants with viral shedding on day 8 following LAIV vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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, FRACP 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 (LAIV) in people with Influenza Vaccines, 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 3 inclusion and 9 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 5 Apr 2024. 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 5 Apr 2024). 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?
Type-specific Vaccine Virus Shedding in 2018/19 - Day 1 Post LAIV (time frame: Assessed on day 1 post LAIV). The study lists 8 primary outcomes in all. 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 5 Apr 2024.