Flu-shed
Research type
Research Study
Full title
Assessment of viral shedding in children previously in receipt of multiple doses of live attenuated influenza vaccine (LAIV) compared to influenza vaccine-naïve controls
IRAS ID
226571
Contact name
Paul Turner
Contact email
Sponsor organisation
Public Health England
Eudract number
2017-000952-24
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
The UK childhood immunisation programme now includes annual influenza vaccine, which is delivered as a nasal spray in a product called Fluenz Tetra. Concern has been raised that the vaccine’s effectiveness may wane over time, as has been observed in the USA where the programme has been suspended, and this study will help us to understand what the mechanism of this may be. \n\nThis is a parallel group, non randomised study which will enrol at least 400 children. Both written informed consent from parent/ guardian and written assent from the child will be in place prior to any study procedure. The two groups will be defined by previous influenza vaccination history, with around half the children naïve to any influenza vaccination (LAIV or IIV) and half having had at least two doses of LAIV with or without prior IIV. All will follow the same schedule of nasal swab, vaccination and oral fluid collection at day 0 (by the nurse in the home or at the GP surgery/hosptial clinic); further nasal swab collection (by the parent at home on days 1,3,6); day 21 oral fluid collection (by nurse or parent at home or at GP surgery).
REC name
London - Hampstead Research Ethics Committee
REC reference
17/LO/0719
Date of REC Opinion
17 May 2017
REC opinion
Favourable Opinion