761. Randomized Study To Compare Immunogenicity And Safety Of Seqirus* Quadrivalent Inactivated Influenza Vaccine With A US-Registered Influenza Vaccine In Paediatric Subjects Aged 5 To 17 Years
Session: Poster Abstract Session: Vaccines: Pediatric
Thursday, October 27, 2016
Room: Poster Hall
Posters
  • ID Week 02 Poster 2400x1200mm D3 (final) 13.10.16.pdf (873.0 kB)
  • Background: Seqirus has commenced a staged clinical program for a quadrivalent inactivated influenza vaccine. Paediatric clinical studies have been initiated following completion of the adult study.

    Methods: Children aged 5 through 17 years were randomized 3:1 to receive Seqirus QIV (n=1709) or US-licensed Fluarix® QIV (n=569) in 2015-16 in the USA. Immunogenicity was based on haemagglutination-inhibition (HI) and assessed pre-vaccination and 28 days post-vaccination. Solicited adverse events were assessed for 7 days post-vaccination and unsolicited adverse events assessed for 28 days post-vaccination. Adverse events were also assessed by age cohorts 5 through 8 years (n=1166) and 9 through 17 years (n=1112). Serious adverse events were followed up for 180 days post-vaccination. (NCT02545543).

    Results: Geometric mean titres and sero-conversion rates for all four strains demonstrate that the immunogenicity of the Seqirus QIV was non-inferior to Fluarix QIV. Solicited and unsolicited adverse events in both treatment arms were similar. 

    Fever rates in children 5 through 8 years old were 4.3% (95% CI: 3.1, 6.0) and 3.6% (95% CI: 1.8, 6.6), for Seqirus QIV and Fluarix QIV, respectively. Severe (≥39oC) fever rates in this age cohort were 1.1% (95% CI: 0.5, 2.1) vs 0.7% (95% CI: 0.1, 2.6), for Seqirus QIV and Fluarix QIV, respectively.

    Conclusion: In children 5 through to 17 years, the immunogenicity and 7-day and 28-day safety and tolerability profile for the Seqirus quadrivalent inactivated influenza vaccine were demonstrated to be non-inferior to Fluarix QIV.

    *Seqirus is a CSL company.

    Jane Leong, MBBS, FRACGP, MBA1, Daphne Sawlwin, MBBS, BMEDSC (IMMUNOLOGY), MSC (CLINICAL EPIDEMIOLOGY)2, Alison Graves-Jones, MPH2, Neil Formica, MBBS MPH MAppEpid1, Jolanta Airey, MD1 and Frank Albano, PhD, MBA1, (1)Seqirus, Parkville, Australia, (2)CSL Limited, Parkville, Australia

    Disclosures:

    J. Leong, None

    D. Sawlwin, None

    A. Graves-Jones, None

    N. Formica, None

    J. Airey, None

    F. Albano, None

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