Lancet Publication Marks Important Advance in Influenza Prevention for Older Adults
CSL Seqirus, the influenza vaccine business of CSL, announced publication of pivotal Phase 3 results for its MF59-adjuvanted cell-based higher-dose quadrivalent flu vaccine (aQIVc) in The Lancet Infectious Diseases. The randomized study enrolled 7,699 adults aged 50 and older across eight countries, showing superiority over an adjuvanted egg-based vaccine across all four strains and non-inferiority versus a recombinant vaccine, with a well-tolerated safety profile. The trivalent formulation is already approved in the UK and EU as AUJEMFLU, with regulatory submissions in multiple additional markets and phased introductions planned.
Key figures
- Drug Name
- aQIVc (MF59-adjuvanted cell-based higher-dose quadrivalent influenza vaccine); trivalent formulation marketed as AUJEMFLU
- Phase Of Trial
- Phase 3
- Countries
- 8
- Enrollment
- 7699
- Primary outcome
- immunogenicity and safety
- Minimum age years
- 50
- Superiority result
- vs adjuvanted egg-based comparator across all four strains and age groups
- Non inferiority result
- vs recombinant vaccine for 3 of 4 strains in 50+ and 4 of 4 strains in 65+
- Mf59 adjuvant per dose mg
- 19.5
- Haemagglutinin per strain ug
- 45
AI analysis
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