Lorna Hazell, Saad AW Shakir, Andrew Finlay, Hannah Coulter, Robert S Brody and Robert P Wise

Background: Fluenz® Tetra is a quadrivalent, live attenuated, intranasal, influenza vaccine recommended for use in children vaccinated as part of the seasonal influenza immunisation programme in the UK. We report results from a pilot safety surveillance programme in England consistent with regulatory guidance for all influenza vaccines.

Objectives

To measure and assess the frequencies of suspected adverse drug reactions (sADRs) in children receiving Fluenz® Tetra during the early 2015/2016 influenza season in England.

Methods

Passive enhanced safety surveillance was conducted through stimulated spontaneous reporting of sADRs. Vaccinees or parents/guardians received a Safety Report Card (SRC) to return if children experienced sADRs after vaccination with Fluenz® Tetra; no time limit for reporting was specified. At participating sites, 42 general practices and 25 primary schools in England, immunisation teams provided numbers of SRCs distributed. The study was approved by an NHS Research Ethics Committee (North West – Liverpool East).

Results

Between 8th October 2015 and 10th January 2016, 8,753 SRCs were issued for 4,134 children (47.2%) aged 2 to 4 years, 4,078 (46.6%) aged 5 to 10 years and 541 (6.2%) aged 11 to 17 years. Of 323 SRCs returned during this period, 165 reported at least one sADR. The most frequently reported sADRs were rhinorrhoea (n=54), cough (35), and pyrexia (31). One serious and unexpected sADR involved a child with flu-like symptoms requiring a hospital visit 2 days after vaccination. The child recovered from the sADR.

Conclusion

These data are broadly comparable with the frequency of adverse events reported for Fluenz® Tetra in clinical trial and post-marketing data, despite differences in methods. No evidence from the limited data available suggests an increased frequency of minor expected events or other safety signals.

Study co-sponsored by DSRU and AstraZeneca.