NCT06760208

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

Korean Post-marketing Surveillance for Prevenar 20

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 660 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 6 Weeks
• Healthy volunteers: Accepted

Summary

The purpose of this study is to understand the safety of Prevenar 20 (Pneumococcal 20-valent conjugate vaccine) once it is out in the Korean market. Prevenar 20 will be given to participants aged 6 weeks or older in Republic of Korea. This study is seeking for participants who are: * Infant, children and adolescents aged 6 weeks to under 18 years or adult who are 18 years or older * Prescribed Prevenar 20 by their physician as per approved product label All participants in this study will receive Prevenar 20 vaccine. 1 dose (0.5 mL) of Prevenar 20 will be given into a muscle, preferably to the shoulder muscle. We will look at the experiences of people receiving the study medicine. This will help us see if the study medicine is safe. Participants will take part in this study for 28 days. During this time, study doctor collects the data of subjects to understand the safety of study medicine. There is no strict fixed visit schedule. If subjects are unable to visit the study clinic 28 days after Prevenar 20 vaccine was given then the safety information will be collected by telephone or e-mail.

Detailed description

The study design will reflect the actual management of subjects in routine clinical practice. The study will be performed by continuous registration method. Investigators enroll subjects who receive Prevenar 20 (Pneumococcal 20-valent conjugate vaccine) for the first time after the start of the study. Data can be collected at routine scheduled and/or unscheduled visits. There is no mandatory fixed visit schedule. Investigator collects the data of subjects from the time of the subject's first dose of study drug to a minimum of 28 days following administration of study drug, to evaluate the safety of study drug and records the information in each subject's Case Report Form. As no additional visits or tests are required for this study, the data specified in this protocol may not be collected from all subjects. Endpoint * Frequency and proportion of solicited systemic reactions occurring from Day 1 through Day 7 after vaccination, where Day 1 is the day of vaccination. * Frequency and proportion of solicited local reactions occurring from Day 1 through Day 10 days after vaccination, where Day 1 is the day of vaccination. * Frequency and proportion of Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs), Serious Adverse Drug Reactions (SADRs), Unexpected AEs, Unexpected ADRs, Unexpected SAEs, and Unexpected SADRs throughout the surveillance period * Frequency and proportion of Adverse Events Special Interest (AESI) throughout the surveillance period * Invasive Pneumococcal Disease All assessments are performed as part of normal clinical practice or standard practice guidelines for the subject population and healthcare provider specialty in the countries where this non-interventional study is being conducted.

Conditions

• Pneumococcal Immunization
• Safety

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal 20-valent conjugate vaccine	For intramuscular use only. One dose (0.5 mL) of Pneumococcal 20-valent conjugate vaccine should be administered intramuscularly, preferably in the deltoid muscle, with care to avoid injection into or near nerves and blood vessels.

Timeline

• Start date: 2025-11-13
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-01-06
• Last updated: 2026-03-12

Locations

1 site across 1 country: South Korea