Safety monitoring of Prevenar 20 in people in Korea
Korean Post-marketing Surveillance for Prevenar 20
This project will see if the Prevenar 20 vaccine is safe for people in the Republic of Korea aged 6 weeks and older who are prescribed it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 660 (estimated) |
| Ages | 6 Weeks and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06760208 on ClinicalTrials.gov |
What this trial studies
This is an observational, post‑marketing safety follow‑up in which people prescribed Prevenar 20 as part of routine care are enrolled continuously after the vaccine becomes available in Korea. Investigators record safety information from the first dose through at least 28 days, using data from routine scheduled or unscheduled clinic visits without requiring extra tests or fixed visits. The study captures solicited local and systemic reactions in the first 7–10 days and collects adverse events, serious adverse events, and adverse events of special interest across the surveillance period. Data are entered into case report forms to summarize the frequency and proportion of reported reactions and adverse events.
Who should consider this trial
Good fit: People in the Republic of Korea aged 6 weeks or older who have been prescribed Prevenar 20 according to the approved label and can provide informed consent (or have a guardian who can).
Not a fit: People with contraindications per the Prevenar 20 label or those who do not consent to data use by the sponsor and its partners would not be eligible and therefore would not receive benefit from participation.
Why it matters
Potential benefit: If successful, the project could confirm the vaccine's real‑world safety profile in Korea and help detect uncommon adverse reactions, increasing clinician and patient confidence.
How similar studies have performed: Prelicensure trials and prior post‑marketing surveillance of pneumococcal conjugate vaccines, including earlier Prevenar formulations, have generally shown acceptable safety profiles, so this is a routine safety monitoring activity.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Infant, children and adolescents who are aged 6 weeks to under 18 years or adult who are 18 years or older 2. Subjects who have been prescribed Prevenar 20 by their physician as per approved product label 3. Evidence of a personally signed and dated informed consent document indicating that the subject or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study Exclusion Criteria: Subjects meeting any of the following criteria will not be included in the study: 1. Subjects with contraindication according to approved label of Prevernar 20 (Pneumococcal 20-valent conjugate vaccine) 2. Any subjects (or a legally acceptable representative) who do not agree that Pfizer and companies working with Pfizer use his/her information
Where this trial is running
Seoul
- Pfizer Korea — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.