An observational study of the nasal influenza vaccine, by measuring how much and what strains of flu virus are seen in the noses of children given the nasal flu vaccine in 2018-19, and comparing this to antibody levels in blood and oral fluid.

Assessment of viral shedding week following administration of live attenuated influenza vaccine in children: FluSHED-2 study - FluSHED-2

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002470-42-GB

Enrollment

Registered

2018-07-10

Start date

2018-08-30

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of influenza infection through immunisation MedDRA version: 20.0 Level: LLT Classification code 10016794 Term: Flu vaccination System Organ Class: 100000004865

Interventions

Trade Name: Fluenz Tetra Product Name: Fluenz Tetra Pharmaceutical Form: Nasal spray INN or Proposed INN: various influenza strains as per below Concentration unit: Other Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children age 6 years to 15 years +364 days of age on enrolment 2. Children eligible to receive LAIV in accordance with Green Book advice [https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book] 3. Written informed consent given by parent/ guardian and assent from child (both must be in place to proceed). Are the trial subjects under 18? yes Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1. Contraindications to LAIV (notwithstanding allergy to egg protein), which include: a. Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue) b. Previous systemic allergic reaction to LAIV c. 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 d. 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 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. e. 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. f. Pregnancy (determined by history). Where this cannot be confirmed, a urine pregnancy test will be performed.

Design outcomes

Primary

Measure	Time frame
Main Objective: Technical version: To measure type-specific vaccine virus shedding in 2018/19 following LAIV administration. Lay version: To measure the amount and strains of flu virus in the nose of children who have had the nasal flu vaccine in the week following their vaccination. ;Secondary Objective: Technical version: Quantitative analysis of immunogenicity using a range of indicators (including HI and/or MN, and nasal IgA responses), and to measure the association between type-specific vaccine immunogenicity and virus shedding. Lay version: To try to understand if the amount of virus found in the nose can be considered a measure of how much immunity a child has developed following vaccination.;Primary end point(s): To measure type-specific vaccine virus shedding in 2018/19 and how this varies in the 8 days following vaccination.;Timepoint(s) of evaluation of this end point: Daily for 8 days following vaccination	—

Measure

Time frame

Main Objective: Technical version: To measure type-specific vaccine virus shedding in 2018/19 following LAIV administration. Lay version: To measure the amount and strains of flu virus in the nose of children who have had the nasal flu vaccine in the week following their vaccination. ;Secondary Objective: Technical version: Quantitative analysis of immunogenicity using a range of indicators (including HI and/or MN, and nasal IgA responses), and to measure the association between type-specific vaccine immunogenicity and virus shedding. Lay version: To try to understand if the amount of virus found in the nose can be considered a measure of how much immunity a child has developed following vaccination.;Primary end point(s): To measure type-specific vaccine virus shedding in 2018/19 and how this varies in the 8 days following vaccination.;Timepoint(s) of evaluation of this end point: Daily for 8 days following vaccination

—

Secondary

Measure	Time frame
Secondary end point(s): Quantitative analysis of immunogenicity using a range of indicators (including HI and/or MN, and nasal IgA responses), and to measure the association between type-specific vaccine immunogenicity and virus shedding.;Timepoint(s) of evaluation of this end point: Nasal, blood and oral fluid samples collected around 4 weeks (window 3-6 weeks) following vaccination	—

Countries

United Kingdom

Contacts

Public ContactTurner

IMPERIAL COLLEGE LONDON

p.turner@imperial.ac.uk02033127754

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026