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.

Phase 1

• Conditions: Prevention of influenza infection through immunisation; MedDRA version: 20.0Level: LLTClassification code 10016794Term: Flu vaccinationSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2018-002470-42-GB
• Lead Sponsor: Imperial College London JRC Office

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-10
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified