Nebenwirkungen · Prevenar 20 (previously Apexxnar)
Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.8 · PDF-Seite 8
HOS-147512 · Präparat HOS-099678
Clinical trials were conducted in healthy infants 6 weeks to less than 15 months of age using a 3-dose schedule or a 4-dose schedule (see section 5.1). In these infant trials, 5 156 participants received at least 1 dose of vaccine: 2 833 received Prevenar 20, and 2 323 received Prevenar 13. Overall, approximately 90% of participants in each group received all doses through the study-specified toddler dose. In all studies, local reactions and systemic events were collected after each dose, and adverse events (AEs) were collected in all studies from the first dose through 1 month after the last infant vaccination and from the toddler dose through 1 month after the toddler dose. Serious adverse events were evaluated through 1 month after the last dose in the Phase 3 trial B7471012 (Study 1012) and through 6 months after the last dose in Phase 3 trials (Studies 1011, 1013) and Phase 2 trial (Study 1003).
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