N/A - the vaccine will be administered to children according to current DH Immunisation schedule for England. MedDRA version: 20.0 Level: LLT Classification code 10016794 Term: Flu vaccination System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Fluenz Tetra
Product Name: Fluenz Tetra
Pharmaceutical Form: Nasal spray
INN or Proposed INN: A/California/7/2009 (H1N1)pdm09 - like strain
Sponsors
Public Health England
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children may only be included in the study if all the inclusion criteria are met: • Children age 6 to 13 years of age on enrolment and with either: o Prior LAIV vaccination (at least 2 doses) over the previous 3 years o Never received LAIV or IIV in previous years • 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] • 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: 400 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: Children may not be included in the study if any of the following apply: 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 2. Contraindications to vaccination on that occasion, e.g. due to child being acutely unwell: a. Febrile =38.0oC in last 48 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. 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. **Items 3b-3d are relative contra-indications: Many children with “difficult-to-control” symptoms fail to meet these criteria on a routine basis. Where these are present, the CI is able to authorise participation on a case-by-case basis, after assessing the child at the time of enrolment. Administration of another live vaccine (e.g. MMR) within the previous 4 weeks is no longer a contra-indication to LAIV administration, according to updated DoH guidelines. NB: See Summary of Product Characteristics for full details of contra-indications to LAIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To measure type-specific vaccine virus shedding and immunogenicity in 2017/18 and determine if there has been any change compared to previous studies in 2016/17 (conducted by this group, Eudract 2013-003592-35 and 2016-002352-24) following change in the A/H1N1pdm09 vaccine virus strain amongst children with the same prior vaccine history ; Secondary Objective: • To determine if there is any association between type-specific vaccine virus shedding and prior vaccine status in 2017/18 • To determine if there is any association between type-specific vaccine virus shedding and baseline HAI immunity in 2017/18 / nasal influenza-specific IgA in 2017/18 ;Primary end point(s): LAIV vaccine virus shedding for the 4 viral strains present in the LAIV vaccines used; A/H1N1pdm09 virus (yes/no), A/H3N2 and B at at least one time point (days 1,3,6).;Timepoint(s) of evaluation of this end point: Days 1,3 and 6 after LAIV administration (on Day 0) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Area under the curve between days 1 and 6 for the quantitative shedding based on viral load and straight lines between levels of virus shed on days for subjects with all 3 swabs. HAI and MN titres to A/H1N1pdm09, A/H3N2 and B at days 0 and 21 as well as whether they show 4 fold changes ;Timepoint(s) of evaluation of this end point: Day 0 and 21 after LAIV administration. | — |
Countries
United Kingdom
Contacts
Public ContactJo Southern
Public Health England
Outcome results
None listed