Lancet Publication Details Phase 3 Win for CSL Seqirus's Triple-Enhanced aQIVc Influenza Vaccine in Older Adults

CSL Seqirus (搜索)搜索该词条, a business of CSL (搜索)搜索该词条 (ASX:CSL; USOTC:CSLLY), has published pivotal Phase 3 results for its MF59查看药品详情®-adjuvanted cell-based higher-dose quadrivalent influenza (搜索)搜索该疾病 vaccine (aQIVc (搜索)搜索该药品) in The Lancet Infectious Diseases, reporting that the vaccine met its primary objectives in a study of 7,699 adults aged 50 years and older. The publication marks the first large-scale evaluation of a vaccine that combines three established enhancement strategies — MF59® adjuvant, cell-based manufacturing, and a higher dose formulation — in a single product.

The trivalent formulation of aQIVc (搜索)搜索该药品, marketed as AUJEMFLU (搜索)搜索该药品®, was approved by the UK Medicines and Healthcare products Regulatory Agency (搜索)搜索该词条 (MHRA) earlier this year for adults aged 50 years and older, and has also been approved by the European Commission查看公司主页 for the same population.

Study Design and Immunogenicity Results

The randomised, observer-blind Phase 3 immunogenicity and safety study enrolled 7,699 adults aged 50 years and older across eight countries: Canada, Denmark, Estonia, Germany, Pakistan, the Philippines, the United Kingdom and the United States. Participants received either the MF59查看药品详情-adjuvanted cell-derived higher dose quadrivalent vaccine, an MF59-adjuvanted egg-based quadrivalent influenza (搜索)搜索该疾病 vaccine, or a recombinant quadrivalent influenza vaccine. The study evaluated immunogenicity, safety and manufacturing consistency.

According to the published findings, aQIVc (搜索)搜索该药品 demonstrated superiority versus the adjuvanted egg-based influenza (搜索)搜索该疾病 vaccine comparator across all four influenza strains and age groups assessed. Against the recombinant influenza vaccine, the vaccine achieved non-inferiority for three out of four strains in the 50+ age group and four out of four strains in those aged 65 and older. Immune responses persisted throughout the influenza season, and the vaccine showed a well-tolerated safety profile, with most reactions mild or moderate and resolving within three days.

The publication also reported exploratory findings of enhanced neuraminidase查看药品详情 antibody responses versus comparators. The role of neuraminidase antibodies is described as an emerging area of influenza (搜索)搜索该疾病 research that may contribute to reduced disease severity and broader protection beyond traditional measures of vaccine response. The study authors concluded that the findings support further evaluation of the vaccine and provide evidence for National Immunisation Technical Advisory Groups considering enhanced influenza vaccination strategies for older adults.

Rationale for a Three-Component Approach

Influenza (搜索)搜索该疾病 remains a significant public health challenge, causing substantial illness, hospitalisations and deaths each year despite widespread vaccination programmes. Older adults are particularly vulnerable because the immune system becomes less responsive with age, reducing its ability to mount a strong protective response following vaccination.

Each of the three approaches incorporated into aQIVc (搜索)搜索该药品 has been used separately in influenza (搜索)搜索该疾病 vaccines for many years and is supported by extensive clinical and real-world evidence. Cell-based manufacturing helps preserve a closer match to circulating influenza strains; MF59查看药品详情® adjuvant strengthens, broadens and lengthens the immune response; and a higher dose formulation further optimises that response. Each dose contains 45 micrograms of haemagglutinin (搜索)搜索该靶点 per influenza strain and 19.5 mg of MF59 adjuvant. The Lancet publication provides the first large-scale evaluation of their combination within a single vaccine.

Professor Colin Russell, Chair of the European Scientific Working Group on Influenza (搜索)搜索该疾病 (ESWI) and Professor of Applied Evolutionary Biology at Amsterdam University Medical Center, framed the significance of the trial in terms of its combinatorial design: "Influenza vaccine innovation has historically progressed through incremental advances in technology and manufacturing. What makes this study noteworthy is that it shows the potential benefit of bringing multiple proven approaches together in a single vaccine."

Russell added that "given the continued burden of influenza (搜索)搜索该疾病-related illness, hospitalisation and death among older adults despite widespread vaccination, these findings represent an important contribution to ongoing efforts to improve protection in this vulnerable population."

Regulatory Status and Next Steps

Gregg Sylvester, Chief Medical Officer and Head of Research & Development at CSL Seqirus (搜索)搜索该词条, said: "Publication in The Lancet Infectious Diseases is a significant milestone for CSL Seqirus and reflects decades of investment in influenza (搜索)搜索该疾病 vaccine innovation." He added that the findings "provide important new evidence for healthcare professionals, policy makers and immunisation advisory groups considering future influenza vaccination strategies for older adults."

Regulatory submissions for the trivalent formulation of aQIVc (搜索)搜索该药品 have been made in multiple markets, with introductions expected to occur through a phased approach aligned to local regulatory, policy and access pathways. CSL Seqirus (搜索)搜索该词条, one of the largest influenza (搜索)搜索该疾病 vaccine providers in the world, operates production facilities in the US, the UK and Australia and utilises egg, cell and adjuvant technologies across a portfolio of differentiated influenza vaccines available in more than 20 countries.

The study authors' conclusion that the data support further evaluation of the vaccine positions the Lancet publication as a reference point for immunisation advisory bodies weighing enhanced influenza (搜索)搜索该疾病 vaccination strategies for older populations.