Delving into the Latest Updates on Seqirus Pty Ltd. with Synapse

It is important people receiving immunosuppressive therapy are provided with the best protection against COVID-19 because they are at greater risk of severe illness should they become infected. As severe immunosuppression can reduce the efficacy of COVID-19 vaccination, doctors agree that COVID-19 boosters is are important to maximise the vaccine response in these people. However, we don't currently know the best time to give booster vaccines to people about to start immunosuppressive therapy. This research aims to address this knowledge gap by examining whether the greatest protection is provided by giving the COVID-19 booster just before the immunosuppressive therapy starts or by waiting and giving the booster 6 months after treatment start. At the 6-month timepoint, in many cases the more intensive immunosuppression is often weaning and the immune system is starting to rebuild.

开始日期2023-07-21

申办/合作机构

Kirby Institute

[+2]

ACTRN12616000161426 / CompletedN/A

A retrospective analysis of the pre-testing results and immunisation rates of the Q VAX vaccine in Australian meat processor and livestock workers from 2002.

开始日期2016-03-08

申办/合作机构

Seqirus Pty Ltd.

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项与 Seqirus Pty Ltd. 相关的文献（医药）

2021-11-02·Human Vaccines & Immunotherapeutics3区 · 医学

Australian experience of the SH21 flu vaccination program during the COVID-19 vaccine program

3区 · 医学

Article

作者: Van Buynder, Paul Gaston ; MacIntyre, C. Raina ; Kennedy, Alexander Thomas ; Clarke, Christopher ; Anderson, Jonathan ; Newbound, Angela

In recent years, Australia has vaccinated increasing numbers of its citizens against seasonal influenza via both government and private vaccine programs, largely between March and July. In 2020, th...

2019-04-01·Vaccine3区 · 医学

Modification of the vaccine manufacturing process improves the pyrogenicity profile of inactivated influenza vaccines in young children

3区 · 医学

Article

作者: Albano, Frank R ; Sawlwin, Daphne C ; Graves Jones, Alison

BACKGROUNDThere were increased reports of fevers and febrile reactions in young children (particularly children aged <5 years) receiving the Seqirus/CSL Southern Hemisphere 2010 trivalent inactivated influenza vaccine (IIV3). Modifying the vaccine manufacturing process by increasing the minimum concentration of splitting agent (sodium taurodeoxycholate [TDOC]) from 0.5% w/v to 1.5% w/v for all strains resolved this issue. The current analysis compared fever rates in three pediatric studies of Seqirus IIV3 (S-IIV3) or quadrivalent inactivated influenza vaccine (S-IIV4), prepared using the modified manufacturing process, with fever rates in three pediatric studies of historical (pre-2010) IIV3 formulations. The historical IIV3 formulations, S-IIV3, and S-IIV4 had 0/3, 2/3, and 4/4 vaccine strains split at 1.5% TDOC, respectively.METHODSFor each study, fever rates (any grade and severe) were determined for the following age subgroups (as applicable), using the fever intensity grading system used in the S-IIV3/S-IIV4 studies: 6 months to <3 years; 3 to <5 years; 5 to <9 years; and 9 to <18 years.RESULTSFor each age subgroup, the any grade and severe fever rates were lower in the S-IIV3/S-IIV4 studies than in the historical IIV3 formulation studies, with the greatest differences in fever rates observed in the youngest age groups. In the 6 months to <3 years group, the any grade fever rate was 7.0% (severe fever: 2.5%) in one S-IIV4 study compared with 38.7% to 40.0% (severe fever: 9.6% to 17.8%) in the historical IIV3 formulation studies. In the 3 to <5 years subgroup, the any grade fever rate was 4.9% (severe fever: 1.2%) in one S-IIV4 study compared with 34.1% to 36.0% (severe fever: 6.3% to 16.5%) in the historical IIV3 formulation studies.CONCLUSIONThis analysis provides clinical evidence that the modified manufacturing process improved the fever profile across all pediatric age groups, in particular, in children aged <5 years.

2019-01-01·Vaccine3区 · 医学

Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in children 6–59 months of age: A phase 3, randomized, noninferiority study

3区 · 医学

Article

作者: Matassa, Vince ; Sawlwin, Daphne C ; Airey, Jolanta ; Heijnen, Esther ; Edelman, Jonathan ; Marshall, Gary S ; Albano, Frank R ; Statler, Victoria A ; Graves Jones, Alison

BACKGROUNDIn the Southern Hemisphere 2010 influenza season, Seqirus' split-virion, trivalent inactivated influenza vaccine was associated with increased reports of fevers and febrile reactions in young children. A staged clinical development program of a quadrivalent vaccine (Seqirus IIV4 [S-IIV4]; Afluria® Quadrivalent/Afluria Quad™/Afluria Tetra™), wherein each vaccine strain is split using a higher detergent concentration to reduce lipid content (considered the cause of the increased fevers and febrile reactions), is now complete.METHODSChildren aged 6-59 months were randomized 3:1 and stratified by age (6-35 months/36-59 months) to receive S-IIV4 (n = 1684) or a United States (US)-licensed comparator IIV4 (C-IIV4; Fluzone® Quadrivalent; n = 563) during the Northern Hemisphere 2016-2017 influenza season. The primary objective was to demonstrate noninferior immunogenicity of S-IIV4 versus C-IIV4. Immunogenicity was assessed by hemagglutination inhibition (baseline, 28 days postvaccination). Solicited, unsolicited, and serious adverse events were assessed for 7, 28, and 180 days postvaccination, respectively.RESULTSS-IIV4 met the immunogenicity criteria for noninferiority. Adjusted geometric mean titer ratios (C-IIV4/S-IIV4) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria strains were 0.79 (95% CI: 0.72, 0.88), 1.27 (1.15, 1.42), 1.12 (1.01, 1.24), and 0.97 (0.86, 1.09), respectively. Corresponding values for differences in seroconversion rates (C-IIV4 minus S-IIV4) were -10.3 (-15.4, -5.1), 2.6 (-2.5, 7.8), 3.1 (-2.1, 8.2), and 0.9 (-4.2, 6.1). Solicited, unsolicited, and serious adverse events were similar between vaccines in both age cohorts, apart from fever. Fever rates were lower with S-IIV4 (5.8%) than C-IIV4 (8.4%), with no febrile convulsions reported with either vaccine during the 7 days postvaccination.CONCLUSIONS-IIV4, manufactured with a higher detergent concentration, demonstrated noninferior immunogenicity to the US-licensed C-IIV4, with similar postvaccination safety and tolerability, in children aged 6-59 months. This completes the program demonstrating the immunogenicity and safety of S-IIV4 in participants aged 6 months and older.FUNDINGSeqirus Pty Ltd; ClinicalTrials.gov identifier:NCT02914275.

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