Korean Post-marketing Surveillance for Prevenar 20 Vaccine Safety

What this Trial Is About

Researchers are studying the safety of Prevenar 20, a Pneumococcal 20-valent conjugate vaccine, after it is available in the Korean market. This observational study includes participants aged 6 weeks and older, including infants, children, adolescents, and adults prescribed the vaccine by their physician according to the approved product label. The study aims to collect data on various reactions and adverse events following vaccination to understand the vaccine's safety profile in routine clinical use. Participants will receive a single 0.5 mL dose of Prevenar 20 injected into a muscle, preferably the shoulder muscle. The study uses a continuous registration method where participants receive the vaccine as part of routine care, and data is collected from their first dose through at least 28 days afterward. There is no fixed visit schedule, and data may be collected during routine or unscheduled visits, or by phone or email if clinic visits are not possible. During the 28-day participation period, researchers will monitor and record any local or systemic reactions, adverse events, serious adverse events, and any unexpected or special interest events related to the vaccine. All assessments align with usual clinical practice, and no additional tests or visits are required beyond standard care. The information collected will help evaluate the vaccine's safety in real-world use.

A Study to Learn More About Prevenar 20 Once it is Out in the Korean Market