Data published in PLOS Medicine confirm that GSK’s SynflorixTM, a paediatric pneumococcal conjugate vaccine (PCV), was effective in preventing likely-bacterial community-acquired pneumonia (CAP)* in infants and young children.(1)
The Clinical Otitis Media and Pneumonia Study (COMPAS) met its primary objective, showing that Synflorix had a significant clinical efficacy of 22% against likely-bacterial CAP.**(1)
Previously published clinical data tested the vaccine’s effectiveness against invasive pneumococcal disease (IPD),(2) but these are the first phase III results to be published on the vaccine’s efficacy against pneumonia.
COMPAS was a phase III, double-blind, randomised controlled study, comprising 24,000 children in three Latin American countries over a period of four years.
In December 2013, the vaccine received European marketing authorisation for the prevention of pneumonia caused by Streptococcus pneumoniae, in infants and children from six weeks up to five years of age.(3)
“There is an important medical need to reduce the burden of pneumonia in children across both developing and developed countries,” said Professor Xavier Sáez-Llorens, one of the principal investigators for the COMPAS trial and Professor of Pediatrics and Chief of the Infectious Disease Department at Hospital del Niño, Panama. “This large-scale trial establishes vaccine clinical efficacy and adds strong evidence indicating that immunisation with Synflorix can help protect millions of children under the age of five from pneumonia and other invasive or non-invasive pneumococcal infections worldwide.”
“Pneumonia is mostly due to infection with several viruses or bacteria. Streptococcus pneumoniae is the leading bacterial pathogen causing pneumonia. The demonstration that more than a fifth of all likely-bacterial CAP cases can be prevented by Synflorix is an important advance that could have a major public health impact.”
Dr William Hausdorff, Vice President and Vaccine Development Leader for Pneumococcal Vaccines at GSK Vaccines said: “GSK is committed to reducing the global burden of pneumonia and we are proud to be the first to support a trial such as COMPAS in Latin America. The data from this trial were pivotal in securing the recent EU approval for the use of Synflorix in the prevention of pneumonia caused by S. pneumoniae, in infants and children from six weeks up to five years of age. This means that more children will potentially have access to Synflorix, hopefully contributing to a substantial reduction in pneumonia cases. The new pneumonia indication complements already existing indications against serious invasive disease (sepsis and meningitis) and acute otitis media, reflecting the clinical efficacy of Synflorix against the broad range of paediatric pneumococcal diseases.”
*Likely-bacterial CAP (B-CAP) is defined as radiologically confirmed community-acquired pneumonia cases with either alveolar consolidation/pleural effusion on the chest X-ray, or with non alveolar infiltrates but with C reactive protein (CRP) ≥40 mg/L.
**Based on data from first disease episodes.
References
1 Tregnaghi MW, et al. Efficacy of pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in young Latin American children: A double-blind randomized controlled trial. PLOS Med 2014;11:e1001657.
2 Palmu AA, et al. Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. Lancet 2013;381:214–22.
3 GSK Press Release: http://www.gsk.com/media/press-releases/2013/synflorix_-receives-european-marketing-authorisation-for-additio.html (accessed 4 June 2013).
