Passive Enhanced Fluenz Tetra Safety Surveillance 2021-22

• Research type

  Research Study

• Full title

  Passive Enhanced Safety Surveillance (ESS) of Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) Fluenz Tetra in Children and Adolescents during the Early 2021-2022 Influenza Season in England

• IRAS ID

  302894

• Contact name

  Sandeep Dhanda

• Contact email

  sandeep.dhanda@dsru.org

• Sponsor organisation

  DSRU Education and Research Ltd

• Clinicaltrials.gov Identifier

  D2560R00007, AstraZeneca study code

• Duration of Study in the UK

  0 years, 7 months, 0 days

• Research summary

  The purpose of this surveillance survey is to collect information on the safety of the nasal seasonal flu vaccine (Fluenz Tetra) in children and teenagers. Although some symptoms (‘side effects’) may be expected after any vaccination, it is important to check whether the pattern of side effects for a vaccine changes each year. This is the 8th consecutive safety surveillance of Fluenz Tetra in England (1 previous active surveillance study & 6 passive).
  The JCVI report that the 2021/ 2022 UK influenza season may be up to 50% larger than typically seen and begin earlier than usual. The expanded influenza vaccination programme that PHE had last year will continue in 2021 /2022 when it is likely that both influenza and COVID-19 are in circulation. The programme will also be extended this year to 4 additional cohorts in secondary school so that all those from years 7 to year 11 will be offered vaccination. Vaccinating children reduces transmission of influenza. Those eligible for NHS influenza vaccination in 2021/ 2022 and eligible for this study are:

  • all children aged 2 to 15 on 31 August 2021
  • those aged 16 & 17 years in clinical risk groups

  The study will be carried out in GP surgeries and schools. Immunisation staff provide an information sheet and Safety Report Card (SRC) to the child/parent or guardian. There is the option to complete the survey online rather than using the SRC. The survey asks simple questions about medical history and symptoms experienced by the child following vaccination. The parent /guardian of the child (<16 years) completes the online survey or SRC on behalf of the child. Informed consent is gained online or by signing the SRC. Children > 16 years can complete this themselves. The survey is voluntary and only needs to be completed if the child experiences any side effects following vaccination. The completed SRC / online survey is returned directly to AstraZeneca (marketing authorisation holder) who is the study funder.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  21/NW/0242

• Date of REC Opinion

  13 Sep 2021

• REC opinion

  Favourable Opinion