MAIDENHEAD, United Kingdom, Aug. 24, 2016 /PRNewswire/ -- Seqirus today announced results of two data integrated analyses from six randomized clinical trials evaluating the safety and immunogenicity of its trivalent MF59-adjuvanted seasonal influenza vaccine in children aged six months to less than six years.1,2 The two analyses were presented at the 28th International Congress of Pediatrics in Vancouver, Canada, 17-22 August 2016.
In one analysis of data from six clinical studies involving more than 10,000 children, 5,542 children were exposed to at least one dose of the trivalent MF59-adjuvanted seasonal influenza vaccine for young children to evaluate immunogenicity (haemagglutination inhibition titres), efficacy (difference in rate of confirmed influenza cases vs placebo or non-adjuvanted vaccines) and safety. Results showed that immunogenicity and efficacy were greater in children who received the trivalent MF59-adjuvanted seasonal influenza vaccine for young children compared to those who received a non-adjuvanted influenza vaccine, while maintaining an acceptable safety profile (≤1% severe events).1
"Seqirus is proud to contribute to the body of evidence supporting the use of adjuvanted vaccines to help protect children from seasonal influenza," said Russell Basser, MD, Senior Vice President of Research & Development at Seqirus. "While it's important to vaccinate people against the flu throughout their lives, the unique properties of an adjuvanted vaccine may potentially offer additional benefits to young children, who have immature immune systems and typically experience the highest incidence of the disease during community outbreaks."
In a second integrated analysis of the same six randomized trials, safety of the trivalent MF59-adjuvanted seasonal influenza vaccine for young children was compared with non-adjuvanted influenza vaccines among 373 young children with underlying medical conditions. Of the children at risk, 179 received the trivalent MF59-adjuvanted seasonal influenza vaccine for young children and 194 received control vaccines. Children with underlying medical conditions most frequently had a medical history of underlying respiratory system illnesses (62–70%). Solicited adverse events (AEs) were experienced by 74%, 73% and 58% of the trivalent MF59-adjuvanted seasonal influenza vaccine for young children, Flu-licensed and Flu-investigational groups, respectively.2
Immunogenicity of the trivalent MF59-adjuvanted seasonal influenza vaccine for young children was assessed in the same at risk population using data from one study. Results showed that geometric mean titers were two to three times higher with the trivalent MF59-adjuvanted seasonal influenza vaccine for young children (n=179) than with control vaccines (n=194) for all three vaccine strains (A/H1N1, A/H3N2 and B). Seroconversion rates were high for both trivalent MF59-adjuvanted seasonal influenza vaccine for young children (79–96%) and control vaccines (83–89%).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
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.
- Patel S., et al. MF59-Adjuvanted Seasonal Inactivated Influenza Vaccine: Well Tolerated and Highly Immunogenic in Young Children – Cumulative Clinical Experience. Oral Presentation. 28th International Congress of Pediatrics, Vancouver, Canada, 17-22 August 2016.
- Patel S., et al. MF59-Adjuvanted Seasonal Inactivated Influenza Vaccine: Well Tolerated and Highly Immunogenic in Young Children With Underlying Medical Condition. Poster Presentation. 28th International Congress of Pediatrics, Vancouver, Canada, 17-22 August 2016.
- Centers for Disease Control and Prevention (CDC). Key Facts about Influenza (Flu) & Flu Vaccine. Updated 2015. Available at: http://www.cdc.gov/flu/keyfacts.htm. Accessed April 2016.
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