, Volume 15, Issue 5, pp 403-423
Date: 13 Sep 2013

13-Valent Pneumococcal Conjugate Vaccine: A Review of Its Use in Infants, Children, and Adolescents

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Abstract

The 13-valent pneumococcal conjugate vaccine (Prevenar 13®; Prevnar 13®) [PCV13] includes 13 serotype-specific polysaccharides of Streptococcus pneumoniae conjugated individually to non-toxic diphtheria CRM197 protein, thus providing wider coverage of pneumococcal serotypes than its 7-valent predecessor (PCV7). For pediatric populations, PCV13 was initially approved for use in infants and children up to 5 years of age, but recently received approval for expanded use (ages 6 weeks to 17 years) in the EU and the USA. This change in labeling was made primarily on the basis of results of Study 3011, which demonstrated the serotype-specific immunogenicity of a single dose of PCV13 in children ≥5 to <10 years of age who had previously received PCV7. Study 3011 also demonstrated functional immune responses after a single dose of PCV13 in a cohort ≥10 to <18 years of age who had not previously received PCV7. Importantly, prior to Study 3011, several randomized studies comparing PCV13 and PCV7 in infants and younger children demonstrated noninferiority of immune responses to the seven serotypes common to both vaccines after a two- or three-dose primary infant series and after the toddler booster dose; immunogenicity and functional immune responses were also demonstrated for the six additional serotypes. The safety and reactogenicity of PCV13 was generally similar to that of PCV7, and PCV13 did not interfere with the immune responses to coadministered routine pediatric vaccines. PCV13 is expected to substantially reduce the incidence of invasive pneumococcal diseases in a manner similar to that which occurred after PCV7 was introduced, and evidence of the protective effectiveness of PCV13 against pneumococcal diseases is emerging.

The manuscript was reviewed by: R. Frenck Jr, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA; H.J. Lee, Department of Pediatrics, Seoul National University College of Medicine, Seoul, Republic of Korea; L. Lee, Center for Biologics Evaluation and Research, US Food and Drug Administration, Bethesda, MD, USA; R. Prymula, University Hospital, Hradec Králové, Czech Republic; C. Weil-Olivier, Department of Pediatrics, University Denis Diderot, Paris, France.