GSK’s Bexsero®▼achieves primary and secondary endpoints with reduced 3-dose schedule (2+1) in safety and immunogenicity study in infants and children
GSK today presented new data for its meningococcal group B vaccine, Bexsero®,1 [Meningococcal group B Vaccine (rDNA, component, adsorbed)] comparing safety and immunogenicity with different dosing schedules in infants and young children, at the annual meeting of the European Society for Paediatric Infectious Diseases (ESPID). The phase IIIb study (V72_28) met its primary and secondary endpoints, showing comparable immune response and safety in infants receiving a reduced schedule of two primary doses of Bexsero plus a booster dose compared to those receiving the current EU approved schedule of three primary doses of Bexsero plus a booster dose.
Dr Thomas Breuer, Chief Medical Officer Vaccines, GSK said: “Meningitis B is a rare but potentially devastating disease that can result in death or life-long disability. We believe that these initial study results may support a reduced dosing schedule, which could mean fewer shots for infants. We look forward to the important additional data that will come out of the UK routine infant immunisation programme with Bexsero, which may enable countries to have different scheduling options in the future.”
Invasive meningococcal B disease is the leading cause of life-threatening meningitis in the industrialised world.2 Although rare, invasive meningococcal B disease develops rapidly, typically amongst previously healthy children and adolescents, and results in high morbidity and mortality.3,4 Initial symptoms can often resemble flu, making it difficult to diagnose.5,6 About one in 10 of those who contract the disease will die, even with appropriate treatment. Additionally, around 10 percent of those who survive the disease may suffer a major physical or neurological disability (limb loss, hearing loss or seizures).4,5
The V72_28 study enrolled 1158 infants and children into four groups using different dosing schedules of Bexsero. One group received the currently recommended three doses of Bexsero (3+1 series) at 2.5, 3.5 and 5 months of age with a booster at 11 months. Two other groups received two doses of Bexsero (2+1 series) at 3.5 and 5 months or 6 and 8 months of age with a booster at 11 months. The final group of older children aged 2 to 10 years received two doses of Bexsero two months apart.
Across the different groups, the majority of infants and children had a high immune response irrespective of the dosing schedule, with similar safety profiles seen across the groups. Safety and tolerability data from this study are consistent with data from previous studies. In addition, concomitant administration of Menjugate® (Meningococcal Group C Conjugate Vaccine) with Bexsero in infants was shown to be non-inferior to Menjugate alone, with similar safety profiles.
The full results for this study are available on clinicaltrials.gov and will be submitted for publication in a peer-reviewed journal.
In September 2015, UK became the first country in the world to implement a routine immunisation programme with Bexsero with a reduced dosing schedule (2+1 series given at 2, 4 and 12 months). The UK programme will provide important additional information about the safety and effectiveness of Bexsero.
GSK has a broad portfolio of approved meningococcal meningitis vaccines – Bexsero as well as the tetravalent vaccine, Menveo.
Bexsero is licensed in more than 35 countries7, including the U.S. These countries include the member states of the European Union and European Economic Area, Australia, Argentina, Chile and Uruguay, where Bexsero is approved for individuals two months of age and older, and in Canada for those aged 2 months to 17 years of age. In the U.S., Bexsero is approved for use in individuals from 10 years through 25 years of age. In Brazil, Bexsero is approved for use in individuals from two months to 50 years of age.
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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2015.
- European Medicines Agency. Bexsero: EPAR - Product Information. Updated 05/11/2015. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002333/WC500137881.pdf. Date last accessed: 03.15.16
- World Health Organization (WHO). New and Under-utilized Vaccines Implementation (NUVI), Bacterial Meningitis. February 2012. Available at: http://apps.who.int/nuvi/meningitis/en. Date last accessed: 03.15.16.
- Chang, Qiuzhi, et al. Meningococcal disease: changes in epidemiology and prevention. Clinical Epidemiology 2012: 237-245. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3470458/pdf/clep-4-237.pdf. Date last accessed: 03.15.16.
- Rosenstein NE, et al. (2001). Meningococcal disease. N Engl J Med, 344, pp.1378-88.
- World Health Organization. (2012). Meningococcal Meningitis Factsheet N°141. Available at: http://www.who.int/mediacentre/factsheets/fs141/en/. Accessed February 2016.
- Thomson MJ, et al. (2006). Clinical recognition of meningococcal disease in children and adolescents. Lancet; 367, pp.397–403.
- Watson PS, Turner DPJ. Clinical experience with the meningococcal B vaccine, Bexsero®: Prospects for reducing the burden of meningococcal serogroup B disease. Vaccine 34 (2016) 875–880 http://dx.doi.org/10.1016/j.vaccine.2015.11.057