GlaxoSmithKline (GSK) said the European Medicines Agency (EMEA) has accepted Synflorix (Pneumococcal Haemophilus influenzae Protein D conjugate vaccine) for review. The 10-valent vaccine is designed to protect children against both invasive pneumococcal disease (IPD) and bacterial respiratory infections such as acute middle ear infections (otitis media).

GSK utilizes a breakthrough approach in pneumococcal vaccine technology with this candidate vaccine. It has been designed with an active carrier protein to induce protection against non-typeable Haemophilus influenzae (NTHi) in addition to Streptococcus pneumoniae.

IPD are infections caused by the S. pneumoniae bacterium, of which the most common diseases are meningitis, invasive pneumonia, and bacteraemia. The vaccine offers the potential for expanded protection against S. pneumoniae serotypes beyond those covered by the current paediatric vaccination, including three serotypes (1, 5, 7F) associated with severe pneumococcal disease in children younger than 5 years of age. The 10 S. pneumoniae serotypes in the candidate vaccine account for over 80 per cent of paediatric invasive pneumococcal disease worldwide. Most of the S. pneumoniae serotypes contained in the vaccine are conjugated to the immunologically active protein D derived from non-typeable Haemophilus influenzae to induce protection against NTHi in addition to S. pneumoniae.

The burden of otitis media worldwide is significant: it is one of the most frequent childhood diseases, the most common reason for physician visits in children under 3 years of age and the most frequent indication for prescription of antibiotics. The pathogens, S. pneumoniaeand NTHi, are recognized as the two leading causes of acute bacterial otitis media, each accounting for up to 40 per cent of cases in children, yet NTHi is currently not vaccine preventable.

Jean Stéphenne, president, GlaxoSmithKline Biologicals, said "We are very pleased with this important step towards the introduction of this vaccine, which is designed to offer a broad protection against pneumococcal disease and a dual pathogen protection against otitis media caused by Strep pneumoniae and non-typeable Haemophilus influenzae. This approach is a continuation of our heritage to develop vaccines which address multiple pathogens with a single vaccine. If approved, this vaccine could further reduce the mortality due to invasive pneumococcal disease and also the significant morbidity associated with a more frequent disease in children, namely otitis media."

S. pneumoniaeand Haemophilus influenzae type b are well known causes of bacterial respiratory infections in young children. Disease caused specifically by Haemophilus influenzae type b is already addressed by existing conjugate vaccines. The "non-encapsulated" or "non-typeable" Haemophilus influenzae (NTHi) strains are also a leading cause of bacterial respiratory infections, yet currently are not vaccine preventable. S. pneumoniae and NTHi are recognized as the two leading causes of acute bacterial otitis media. Middle ear infections are a very common disease of childhood. In addition to the impact on the quality of life of many children and their families, middle ear infections also pose a significant medical and economic burden to healthcare systems.

Building on the platform of pneumococcal conjugate vaccination, this vaccine has been designed to confer dual protection against paediatric pneumococcal serotypes as well as potentially the second pathogen, NTHi, with a single vaccine. In the Pneumococcal Otitis Efficacy Trial (POET), an earlier prototype of the candidate vaccine provided evidence of dual protection against acute otitis media caused by both S. pneumoniae and NTHi.11 This approach is a continuation of the GSK heritage to develop combination vaccines which address several different pathogens at the same time with only one vaccine. Regulatory filings for this vaccine in additional countries have happened in parallel with the EU filing and will continue in 2008.