Seqirus presents analysis reinforcing the safety and immunogenicity profiles of its MF59®-adjuvanted seasonal trivalent influenza vaccine in adults 65 years and older

NOTE TO EDITORS: The influenza vaccines business, previously owned by Novartis, has been integrated into CSL's influenza vaccine business and now operates as Seqirus.

- An integrated safety analysis of 36 clinical trials was performed for MF59®-adjuvanted seasonal trivalent influenza vaccine in adults aged 65 years of age and older[1]  

- MF59®-adjuvanted seasonal trivalent influenza vaccine demonstrated increased breadth of antibody responses in comparison to non-adjuvanted trivalent vaccines (TIV)[2]  

- As the second largest vaccine provider in the world, Seqirus is committed to delivering a broad range of options to help protect against seasonal influenza  

MAIDENHEAD, United Kingdom, Aug. 26, 2016 /PRNewswire/ -- Seqirus today announced results from three analyses of a total of 42 clinical trials that evaluated the safety and immunogenicity of its MF59®-adjuvanted seasonal trivalent influenza vaccine in adults 65 years of age and older. The analyses, which add to the body of evidence of benefit in using adjuvanted influenza vaccines among elderly patient populations were presented at the Options IX for the Control of Influenza conference (Options IX) in Chicago, 24-28 August 2016.^1,2

The first integrated analysis of safety data from 36 clinical trials assessed the risk of less common but serious adverse events with MF59-adjuvanted seasonal trivalent influenza vaccine in adults aged 65 years and older compared to non-adjuvanted trivalent influenza vaccines. Results showed vaccination with MF59-adjuvanted seasonal trivalent influenza vaccine resulted in an increase in mild to moderate solicited adverse events (AEs) as compared to non-adjuvanted trivalent vaccines, but no increased risk of unsolicited AEs, including serious AE or deaths. Results also suggested that revaccination with MF59-adjuvanted seasonal trivalent influenza vaccine in subsequent influenza seasons was well tolerated in older adults 65 and older.¹

"Adults aged 65 years and older are at a greater risk of serious complications from influenza compared with younger adults because the immune system may weaken with age," said Gregg C. Sylvester, MD, MPH, Vice President, Medical Affairs, Seqirus. "We are proud to build upon the body of evidence demonstrating the safety profile of our MF59-adjuvanted seasonal trivalent influenza vaccine."

In a second analysis of data from four clinical trials, the immunogenicity of MF59-adjuvanted seasonal trivalent influenza vaccine against heterologous seasonal influenza virus strains was evaluated among adults aged 65 years and older immunized with either MF59-adjuvanted seasonal trivalent influenza vaccine or a non-adjuvanted trivalent vaccine comparator. The MF59-adjuvanted seasonal trivalent influenza vaccine demonstrated increased breadth of antibody responses in comparison to non-adjuvanted comparators.

The third analysis, using samples of two seasonal licensure Phase II trials in adults aged 61 years and older, evaluated the heterologous antibody response against the antigenically drifted H3N2 strain during the 2014-2015 season in individuals vaccinated with either MF59-adjuvanted seasonal trivalent influenza or non-adjuvanted trivalent vaccine comparator.

The data from the clinical trials and post licensure studies suggest that MF59-adjuvanted seasonal trivalent influenza vaccine generated a higher percentage of significant antibody titer increase against both vaccine strain-specific and heterologous influenza virus strains.²                                          

About the Studies
The integrated safety analysis assessed nearly 13,000 patients aged 65 years and older. The analysis included 15 randomized controlled trials (RCTs) with a TIV control, 17 single cohort seasonal trials, and four trials which compared different vial configurations and formulations of MF59-adjuvanted seasonal trivalent influenza vaccine. Results showed vaccination with MF59-adjuvanted seasonal trivalent influenza vaccine resulted in an increase in mild to moderate solicited adverse events (AEs) as compared to non-adjuvanted trivalent vaccines, but no increased risk of unsolicited AEs, including serious AE or deaths.¹

In the second analysis examining immunogenicity of MF59-adjuvanted seasonal trivalent influenza vaccine, data from four clinical trials conducted over 19 years showed seroconversion rates were significantly higher with MF59-adjuvanted seasonal trivalent influenza vaccine than the comparator vaccine (lower 95% CI exceeding 0) in nine of 10 heterologous strains tested. Similarly, geometric mean titers (GMT) amongst subjects vaccinated with MF59-adjuvanted seasonal trivalent influenza vaccine were significantly greater (lower 95% CI of the GMT ratio exceeding 1) in seven of 10 strains tested.

To specifically examine the heterologous antibody response against the antigenically drifted H3N2 strain during the 2014-2015 season, we used sera samples from two 2013/14 NH seasonal licensure Phase II trials. Microneutralization assays against the vaccine matched A/Texas/50/2012 or A/Hong Kong/5738/2014 viruses were performed with samples from individuals 61 years of age and older vaccinated with either the 2013/14 NH MF59-adjuvanted seasonal trivalent influenza vaccine or non-adjuvanted TIV comparator. 32 percent of subjects vaccinated with MF59-adjuvanted seasonal trivalent influenza vaccine showed seroconversion as measured by a fourfold or greater increase in antibody titers over pre-vaccination titers against the A/Texas cell version, while only 13 percent of those vaccinated with TIV showed seroconversion.²   40 percent of individuals vaccinated with MF59-adjuvanted seasonal trivalent influenza vaccine seroconverted against the A/Hong Kong strain, whereas only 13 percent of individuals vaccinated with the non-adjuvanted TIV comparator seroconverted.²   

About Seasonal Influenza
Influenza is a common, highly contagious infectious disease that can cause severe illness and life-threatening complications in many people. Because transmission to others may occur one day before symptoms develop and up to five to seven days after becoming sick, the disease can be easily transmitted to others. Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases death.³ On average, more than 200,000 people are hospitalized due to influenza-related complications in the US each year.⁴

About Seqirus
Seqirus is the new global company created in July 2015 from the combined strength and expertise of bioCSL Inc. and the influenza vaccines business formerly owned by Novartis AG. As the second largest influenza vaccine provider in the world, Seqirus is driven by the promise it shares with parent company, CSL Limited, to provide medicines that help to protect and save lives.

Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally, with extensive research and production expertise and manufacturing plants in the US, Europe and Australia and a commercial presence in 20 countries.

Seqirus is part of CSL Limited (ASX: CSL), headquartered in Melbourne, Australia. The CSL Group of companies employs more than 16,000 people with operations in more than 30 countries.

For more information visit www.seqirus.com and www.csl.com.

References

1. Leav B, et al. MF59® Adjuvanted Seasonal Trivalent Influenza Vaccine: Pooled Analysis of Safety in Older Adults ≥65 Years of Age. Presented at Options IX for the Control of Influenza Conference, Chicago, USA, 24-28 August 2016.
2. Settembre, E., et al. Antibody Responses Against Antigenically Drifted Strains of FLUAD™, a Seasonal MF59® Adjuvanted Trivalent Influenza Vaccine in Older Adults. Presented at Options IX for the Control of Influenza Conference, Chicago, USA, 24-28 August 2016.
3. Centers for Disease Control and Prevention (CDC). Key Facts About Seasonal Flu Vaccine. Available at: http://www.cdc.gov/flu/protect/keyfacts.htm. Accessed April 2016.
4. Thompson WW, Shay DK, Weintraub E, et al. Influenza-associated hospitalizations in the United States. JAMA. 2004;292(11):1333-1340.

Related Links

http://www.seqirus.com