Phase III data show GSK paediatric candidate vaccine’s potential to provide improved protection

Phase III data show GSK paediatric candidate vaccine's potential to provide improved protection against life-threatening pneumococcal diseases

Based on pneumococcal serotype distribution in europe, candidate vaccine can be estimated to prevent over 80 % of invasive pneumoccocal disease in children aged under 5 years.

Issued - Wednesday 11 June 2008, London, UK & Rixensart, Belgium

Phase III data presented for the first time at the 6th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD, Reykjavik, Iceland) indicate that GlaxoSmithKline's paediatric candidate vaccine SynflorixTM should offer protection to children against most major strains of Streptococcus pneumoniae - bacteria responsible for life-threatening invasive diseases such as meningitis and sepsis.[i], [ii]

The candidate vaccineprovides broader coverage against invasive disease, compared to the currently available paediatric vaccination1,2 as it includes three additional pneumococcal strains - 1, 5 and 7F - that are not currently vaccine preventable. These strains cause a significant number of severe childhood invasive diseases, accounting for 5-25% of all cases in different regions of the world and are an increasingly prominent cause of serious disease in Europe.[iii],[iv],[v],[vi] Moreover, the candidate vaccine has been designed with an active carrier protein to induce protection against non-typeable Haemophilus influenzae (NTHi) in addition to S. pneumoniae. The bacteria S. pneumoniae and NTHi are the two leading causes of bacterial middle ear infections (otitis media), each accounting for up to 40 % of cases.[vii]

The immunogenicity data presented today show that the candidate vaccine elicited comparable biologically active antibody responses for each of the 7 S. pneumoniae serotypes common between the GSK candidate vaccine and the currently available 7-valent paediatric pneumococcal conjugate vaccine. Depending on serotype, at least 87.3 and up to 100 percent of subjects studied reached the antibody response threshold in the candidate vaccine group.2  For the 3 additional serotypes contained only in the candidate vaccine, at least 93.1 percent of subjects studied reached the antibody response threshold.2   Depending on the relative importance of serotypes 1, 5 and 7F in a respective region or country of the world, GSK's candidate vaccine has the potential to prevent more invasive pneumococcal disease than the 7-valent vaccine.2

Jean Stéphenne, President of GlaxoSmithKline Biologicals, said, "The data presented today are extremely encouraging and represent a major step forward to a pneumococcal conjugate vaccine formulation, specifically designed to address the global epidemiology of pneumococcal disease in both developed and developing countries."

The candidate vaccine was filed for regulatory review with the EMEA in Europe in January 2008 with regulatory filings in the International Region in parallel. Additional regulatory submissions are ongoing.

World Health Organisation (WHO) Prequalification (PQ)

Given the high unmet medical need in many parts of the world due to S. pneumoniae serotypes including 1, 5 and 7F, GSK has submitted a file for this potentially life-saving vaccine to the World Health Organization (WHO) for prequalification (PQ). Prequalification is a service provided by the WHO to facilitate access to medicines in less-affluent countries. A WHO prequalification would facilitate rapid access by developing world countries once the candidate vaccine is approved in Europe.

Dr. Orin Levine, Executive Director, GAVI's pneumoADIP, commented, "The fact that GSK has filed their candidate vaccine for WHO prequalification is evidence of their commitment to global access.  Pneumococcal vaccines are crucial for global health, since pneumococcal disease is estimated to be the number one cause of vaccine preventable deaths in children under five years of age."

Notes to Editors

Impact of IPD

Diseases caused by S. pneumoniae are a major health issue. They are estimated to cause the death of one million children worldwide under the age of five each year.[viii]  Despite the current availability of a childhood pneumococcal vaccine, invasive pneumococcal disease remains a health risk.6 The WHO states that pneumococcal conjugate vaccines should be a priority for inclusion in national childhood immunisation programmes.[ix]

Coadministration of PHiD-CV with other vaccines

These programs require co-administration of paediatric vaccines, and further data presented at the ISPPD congress provide additional evidence that the candidate vaccine can be co-administered with other routinely used paediatric vaccines.[x]  It has been specifically designed with a novel carrier protein - Haemophilus influenzae protein D - to reduce the risk of potential interference with co-administered vaccines routinely used in paediatric vaccination schedules. Additional data presented at ISPPD show that antibody responses for all co-administered vaccines are comparable with previous studies, supporting the evidence that the candidate vaccine does not interfere with co-administered paediatric vaccines.[xi]

GlaxoSmithKline's Pneumococcal non-typeable Haemophilus influenzae Protein D conjugate candidate vaccine (PHiD-CV)

Building on the platform of pneumococcal conjugate vaccination, this candidate vaccine has been designed to offer dual protection against paediatric pneumococcal serotypes, as well as potentially the non-typeable Haemophilus influenzae (NTHi) bacterium, within a single vaccine. In the Pneumococcal Otitis Efficacy Trial (POET), an earlier 11-valent prototype of the candidate vaccine provided evidence of dual protection against acute otitis media caused by both S. pneumoniae and NTHi. [xii]     

About GlaxoSmithKline Biologicals

GlaxoSmithKline Biologicals (GSK Biologicals) is a global vaccine company which has shown itself to be a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Biologicals has 14 manufacturing sites strategically positioned around the globe. In 2007 GSK Biologicals distributed 1.1 billion doses of vaccines to 169 countries in both developed and the developing world - an average of 3 million doses a day.

GSK Biologicals employs over 9 000 people worldwide including more than 1 600 passionate scientists engaged in research aimed at discovering innovative vaccines that contribute to the health and well-being of people of all generations around the world.

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