Published in:
01-09-2012 | Adis Drug Profile
Pneumococcal Polysaccharide Conjugate Vaccine (13-Valent, Adsorbed)
In Older Adults
Published in: Drugs | Issue 9/2012
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Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) [PCV13] is approved for protection against pneumococcal disease in children aged 6 weeks to 5 years and adults aged ≥50 years.
In randomized trials in adults aged 60–64 years (not previously vaccinated with 23-valent pneumococcal polysaccharide vaccine [PPV23]) and ≥70 years (previously vaccinated with PPV23), PCV13 was non-inferior to PPV23 in opsonophagocytic assay (OPA) geometric mean titres (GMTs) for all 12 serotypes common to the two vaccines. More PCV13 than PPV23 recipients had ≥4-fold increases in serotype 6A OPA GMTs (serotype 6A is not included in PPV23). PCV13 recipients also had higher OPA GMTs and met superiority criteria for most serotypes.
Adults aged 50–59 years had antibody responses to PCV13 that were noninferior to those in adults aged 60–64 years for all included serotypes. PCV13 administered concomitantly with trivalent inactivated influenza vaccine in adults aged 50–59 or ≥65 years produced antibody responses that were noninferior to those following sequential administration, except for influenza strain A/H3N2 and pneumococcal serotype 19F in those aged ≥65 years. Antibody responses were numerically higher with sequential administration, although the clinical significance of this is unknown.
Adverse events within 14 days of vaccination were mostly of mild-to-moderate severity, with serious events occurring in 0.2–1.4% of PCV13 and 0.4–1.7% of PPV23 recipients.