GSK announces first participant vaccinated in Phase 3 Clinical Trials of its 5-in-1, Meningitis ABCWY vaccine candidate

• The Phase 3 study is evaluating the safety, tolerability and immunogenicity of GSK's MenABCWY vaccine candidate compared to BEXSERO and MENVEO in adolescents and young adults
• Study investigators to enrol 3,650 participants aged 10-25 years in Canada, the U.S., Europe, Turkey and Australia

MISSISSAUGA, ON, Aug. 31, 2020 /CNW/ - GlaxoSmithKline plc (LSE: GSK) (NYSE: GSK) announced that a multi-national phase III clinical program investigating its 5-in-1 meningitis (MenABCWY) vaccine candidate compared to licensed meningococcal vaccines, BEXSERO (meningococcal group B vaccine) and MENVEO (meningococcal groups A,C, Y, and W-135 vaccine) has begun globally, with patient dosing expected to commence in Canada in September 2020.

Emmanuel Hanon, Senior Vice President and Head of Vaccines R&D for GSK, said: "Entering the final stage of clinical trials with our 5-in-1, MenABCWY vaccine candidate is a major step toward GSK's goal of reducing meningococcal disease around the world.  This vaccine candidate builds on the heritage of BEXSERO and MENVEO and we would like to thank all the scientific researchers, medical partners, advocates and families around the world who also hope for a successful outcome."

The initial Phase 3 studies ^[1] (NCT04502693) will be conducted in individuals aged 10-25 years in Canada, the United States, Europe, Turkey and Australia and the study investigators will enrol 3,650 participants. The trial will evaluate safety, tolerability and immunogenicity of GSK's 5-in-1, MenABCWY vaccine candidate compared to licensed meningococcal vaccines, BEXSERO and MENVEO.

Five meningitis serogroups -- A, C, W, Y and B -- account for nearly all cases of invasive meningococcal disease (IMD) and there is no 5-in-1 combination vaccine currently available ^[2]. Meningitis caused by serogroup B (MenB) is responsible for the majority of cases of IMD in Canada ^[3].

The first vaccination of the multi-national Phase 3 trial's first participant is a pivotal milestone in GSK's leadership in meningitis vaccine research and development.  Since their first approvals in 2010 and 2013 respectively, GSK has distributed more than 58 million doses of MENVEO (meningococcal groups A, C, Y, and W-135 vaccine) and more than 52 million doses of BEXSERO (meningococcal group B vaccine) world-wide.

Lori Knox, Director, Clinical Development Vaccines, GSK Canada, said: "We're excited to reach this important milestone in the development of a 5-in-1, MenABCWY vaccine. It offers the potential to help protect against all 5 vaccine-preventable serogroups with one combined product."

As with all vaccines at this stage of development, safety and efficacy of GSK's MenABCWY vaccine are being evaluated and market authorization has not yet been obtained.

About Invasive Meningococcal Disease

Invasive Meningococcal Disease (IMD) is uncommon,^[4] with reported cases ranging from 0.1 to 2.4 cases per 100,000 population across multiple countries in 2017^[5]. However, this potentially serious and unpredictable disease can kill in as few as 24 hours ^[6] and is the leading cause of life-threatening bacterial meningitis in most of the industrialized world ^[7]. While meningococcal disease is uncommon, about one in 10 of those who contract the disease will die, even with appropriate treatment ^[8]. Additionally, around 20 percent of those who survive the disease may suffer a major physical or neurological disability (limb loss, hearing loss or seizures) ^[9].

Increased rates of meningitis could be due to risk factors including close contact with others, sharing drinks or eating utensils, kissing or coughing.^[10],^[11]. In adolescents and young adults, U.S. surveillance studies have shown that between 2014-2017, the relative risk of contracting MenB was 3.5 to 5 times higher in college students aged 18-24 years compared with peers not attending college.^**†

^*(95% confidence interval = 14.9%–19.9%).

^**0.17 cases in college students vs. 0.05 cases in peers not attending college per 100,000 population in 2014-2016 ^[10]

^†0.22 cases in college students vs. 0.04 cases in peers not attending college per 100,000 population in 2015-2017^[11]

About BEXSERO  

BEXSERO is licensed in more than 40 countries including Canada. BEXSERO is indicated for active immunization of individuals from 2 months through 25 years of age against invasive disease caused by N. meningitidis serogroup B strains.

Please consult the Product Monograph at www.gsk.ca for complete safety information. The Product Monograph is also available by calling 1-800-387-7374.

About MENVEO

MENVEO has been approved in 62 countries including Canada. MENVEO is indicated for active immunization of individuals 2 months through 55 years to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135.

Please consult the Product Monograph at www.gsk.ca for complete safety information. The Product Monograph is also available by calling 1-800-387-7374.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

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 2019 and as set out in GSK's Principal risks and uncertainties" section of the Q2 Results and any impacts of the COVID-19 pandemic. 

Trademarks are owned by or licensed to the GSK group of companies.

References
[1] https://clinicaltrials.gov/ct2/show/NCT04502693?term=205416&draw=2&rank=1 identifier NCT04502693
[2] World Health Organization (WHO), 2018. Meningococcal meningitis Fact sheet no 141. Available at: https://www.who.int/news-room/fact-sheets/detail/meningococcal-meningitis [Accessed March 2020]
[3] Vaccine Preventable Disease: Surveillance Report to December 31, 2015. Available at https://www.canada.ca/en/public-health/services/publications/healthy-living/vaccine-preventable-disease-surveillance-report-december-31-2015.html#a64 
[4] Pelton SI. Meningococcal disease awareness; Clinical and epidemiological factors affecting prevention and management in adolescents. J Adolesc Health. 2010;46:S9-S15
[5] European Centre for Disease prevention and Control (ECDC). Surveillance report: Invasive meningococcal disease – Annual Epidemiological Report for 2017. Available at: https://ecdc.europa.eu/en/publications-data/invasive-meningococcal-disease-annual-epidemiological-report-2017 [Accessed march 2020]
[6] Thompson MJ et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet. 2006;367:397-403
[7] Rappuoli R et al. Meningococcal B vaccine (4CMenB): the journey from research to real world experience. Expert Rev Vaccines. 2018;17(12):1111-1121
[8] World Health Organization (WHO), 2018. Meningococcal meningitis Fact sheet no 141. Available at: https://www.who.int/news-room/fact-sheets/detail/meningococcal-meningitis [Accessed March 2020
[9] World Health Organization (WHO), 2018. Meningococcal meningitis Fact sheet no 141. Available at: https://www.who.int/news-room/fact-sheets/detail/meningococcal-meningitis [Accessed March 2020]
[10] Walker TY, Elam-Evans LD, Yankey D, et al. National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13–17 Years — United States, 2018. MMWR Morb Mortal Wkly Rep 2019;68:718–723. DOI: http://dx.doi.org/10.15585/mmwr.mm6833a2external icon 
[11] Gary S Marshall, Amanda F Dempsey, Amit Srivastava, Raul E Isturiz, US College Students Are at Increased Risk for Serogroup B Meningococcal Disease, Journal of the Pediatric Infectious Diseases Society,piz024, https://doi.org/10.1093/jpids/piz024

SOURCE GlaxoSmithKline Inc.

GSK enquiries: UK Media enquiries: Simon Steel, [phone] (London); Simon Moore, [phone] (London); Canada Media enquiries: Corporate Communications, [phone] (Mississauga), [phone] (Laval)

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