Abstract

The licensed 7-valent pneumococcal conjugate vaccine (PCV7) has successfully reduced incidence of invasive pneumococcal disease (IPD) (>95%) and decreased pneumococcal acute otitis media (AOM) and community acquired pneumonia. After these fundamental randomized and controlled studies PCV7 is considered now as a golden standard for any new subsequent pneumococcal conjugate vaccine which need to be produced for increasing incidence of IPD caused with serotypes absent in PCV7 (serotype replacement). As the result of head to head comparative investigations PHID-CV appeared to be immunogenically non inferior to PCV.In randomized, controlled clinical study (POET) at this time 11-walent PHiD–CV appeared efficient reducing pneumococcal (>50%) and NTHi (>35%) and any AOM (33%). PHID-CV also significantly reduced pneumococcal nasopharyngeal carriage. For prematures appeared to be sufficiently safe and immunogenic.In wide population vaccinations PhiD-CV appeared to be sufficiently immunogenic in 2+1 schedule. In Canadian studies on effectiveness of PHiD-CV appeared to be more effective in reducing IPD in comparison to previously applicated PCV7. At the moment there are in the course two important randomized controlled studies. In COMPAS efficacy study in the South America >20% reduction of consolidated CAP has been observed. In Finland the efficacy study (FinIP) on incidence of AOM and IPD is in the course. On the basis of the last epidemiology study of IPD in Poland it is possible to calculate that PHiD-CV cover more than 70% serotypes present in Poland and a new PCV13–86%.

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