Children aged 2-18 years (inclusive), some of whom will have asthma and/or food allergies. MedDRA version: 18.0 Level: LLT Classification code 10001738 Term: Allergy System Organ Class: 100000004870
Conditions
Interventions
Trade Name: Fluenz Tetra nasal spray suspension Influenza vaccine
Product Name: Fluenz Tetra
Pharmaceutical Form: Nasal spray, suspension
INN or Propose
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 2 – 18 years. 2. Written informed consent from parent/guardian (or the patient themselves from age 16 years), with assent from children aged 8 years and above wherever possible. Are the trial subjects under 18? yes Number of subjects for this age range: 200 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 site PI 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 of prednisolone at 20mg or more per day (any age); or for children under 20kg, a dose of 1mg/kg/day or more. 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 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. f. pregnancy 2. Contraindication to vaccination on that occasion, e.g. due to child being acutely unwell: a. Febrile =38.0oC in last 72 hours b. Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child’s treating healthcare professional c. Recent admission to hospital in last 2 weeks for acute asthma d. Current oral steroid for asthma exacerbation or course completed within last 2 weeks e. Received any blood or blood products within the past 12 weeks f. 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. Recent antihistamine use is not a contra-indication to LAIV administration, but use of any antihistamine in the 96 hours prior to LAIV will be logged on the CRF.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is the intranasal LAIV influenza ('flu) vaccine effective in children? ; Secondary Objective: 1) Do laboratory tests (both blood test and a nasal swab) correlate with vaccine effectiveness? 2) Is the intranasal LAIV influenza ('flu) vaccine effective and safe in children, including those with asthma / a history of recurrent wheezing? ;Primary end point(s): Incidence of laboratory confirmed influenza and other respiratory viruses in participants receiving LAIV, compared to their unvaccinated sibling controls.;Timepoint(s) of evaluation of this end point: Up to the end of the influenza season (end March 2016) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Immune response to vaccine and non-vaccine influenza strains before and after a single dose of LAIV administration, with respect to i. serological measures, including: • Geometric mean titre. GMTs (with 95% confidence intervals) for HI (H3N2, H1N1, H7N9, B) and MN (H1N1 and H7N9) prior to and 3-6 weeks post LAIV (pre and post bleed); • Geometric Mean Ratio. GMRs (95% CI) will be calculated for the HI, MN results (for all viruses) for post bleed / pre bleed (day 0) sample; • Percentages of subjects with Seroconversion or Significant Increase in HI and MN Titre. Seroconversions or significant increase (negative titres at D0; <10 and = 40 at D21 or at least 4-fold increase in titre) in HI titres or MN (for all viruses) from pre-immunization to 3-6 weeks post LAIV (pre and post bleed); • Percentages of subjects achieving each of the following thresholds: HI = 40, MN = 40; MN = 80, four-fold rise in MN titres: The number and proportion of subjects achieving each threshold prior to and 3-6 weeks post LAIV (pre and post bleed) will be tabulated for all viruses. ii. Change in specific nasal IgA responses prior to and 3-6 weeks post LAIV (and how these correlate to the above serological measures) with sub-analyses according to whether participants have received prior vaccination with pandemic influenza vaccine / LAIV / both. 2. To monitor for 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 four week | — |
Countries
United Kingdom
Contacts
Public ContactDr Paul Turner
Imperial College London
Outcome results
None listed