LAIV PROTECT
Research type
Research Study
Full title
Protection induced by Live Attenuated Influenza Vaccine (LAIV or Fluenz Tetra) - applied epidemiological study
IRAS ID
185035
Contact name
Richard Pebody
Contact email
Eudract number
2015-003250-41
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Vaccines are the most effective tool in preventing infection and transmission of influenza. In the UK, influenza vaccination is recommended for high risk groups. In July 2012, the UK’s Joint Committee on Vaccines and Immunisation (JCVI) recommended the introduction of vaccination for all children aged 2-16 years against flu using live attenuated influenza vaccine (LAIV). The roll out of LAIV vaccination was initiated by Public Health England in 2013.
This vaccine is well established in the USA and other non-European countries. Several randomized control trials show LAIV is approximately 80% effective in children aged 6 months to 7 years, outperforming placebo or TIV vaccination and it has proved to be safe and well-tolerated. Despite the established history of high vaccine efficacy, recent data from the USA has suggested lower vaccine efficacy against pandemic A(H1N1)pdm09 infection in young children in 2013-14 and with most LAIV efficacy and safety data originating from studies outside the UK, there is strong rationale for continued surveillance.
The national roll out of LAIV vaccination provides a unique opportunity to study the protective efficacy and safety of LAIV in a community of UK school children. The study will determine:
- efficacy and safety of LAIV vaccination in a UK population of relevant school age
- the effect of previous exposure to influenza infection or vaccination on the protective effect of LAIV
- the impact of vaccinating children on unvaccinated populations (herd immunity) by recording influenza infection amongst school staff.REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/1401
Date of REC Opinion
15 Sep 2015
REC opinion
Further Information Favourable Opinion