Pneumococcal Polysaccharide Conjugate Vaccine (13-Valent, Adsorbed) [Prevenar 13 (R)]

The pneumococcal polysaccharide conjugate vaccine Prevenar 13 (R) (PCV13) comprises 13 capsular Streptococcus pneumoniae polysaccharide serotypes that are individually conjugated to nontoxic diphtheria protein (cross-reactive material [CRM197]). In randomized, comparator-controlled, phase III trials in healthy infants aged 2-6 months, PCV13 elicited a strong immune response against all 13 pneumococcal serotypes in terms of the proportion of vaccinees achieving reference antibody levels with a two- or three-dose primary vaccination series. Immune responses for the seven serotypes common to PCV13 and the 7-valent pneumococcal conjugate vaccine Prevenar (R) (PCV7) were generally similar. Antibodies to all vaccine serotypes were functional. A booster dose of PCV13 administered between 11 and 15 months of age generally boosted the immune response against all 13 serotypes, regardless of whether infants had previously received PCV13 or PCV7 during the primary vaccination phase. Robust immune responses against all serotypes were achieved when PCV13 was administered as catch-up vaccination schedules in older infants and young children aged 7-72 months. Importantly, PCV13 did not interfere with the immune responses to coadministered routine paediatric vaccines. Based on data for PCV7, it is expected that PCV13 will also display protective efficacy against invasive pneumococcal disease, otitis media and pneumonia. PCV13 was generally well tolerated, with an adverse event profile similar to that of PCV7 after any vaccine dose.