Safety monitoring of Prevenar 20 in people in Korea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.