Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06760208

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pneumococcal Immunization Safety

Age range

6 week and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Korea

Seoul, South Korea

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  • Infant, children and adolescents who are aged 6 weeks to under 18 years or adult who are 18 years or older
  • Subjects who have been prescribed Prevenar 20 by their physician as per approved product label
  • 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:

  • Subjects with contraindication according to approved label of Prevernar 20 (Pneumococcal 20-valent conjugate vaccine)
  • Any subjects (or a legally acceptable representative) who do not agree that Pfizer and companies working with Pfizer use his/her information

Treatment and study plan

Pneumococcal 20-valent Conjugate Vaccine

Biological

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.

Primary outcomes

  1. Frequency of solicited systemic reactions

    Time frame: From Day 1 through Day 7 after vaccination, where Day 1 is the day of vaccination

    The safety analysis set consists of all subjects who are prescribed Pneumococcal 20-valent conjugate vaccine by the investigator in the routine care, received at least one dose of Pneumococcal 20-valent conjugate vaccine according to the approved product label in Korea, and have at least one safety follow-up.

  2. Frequency of solicited local reactions

    Time frame: From Day 1 through Day 10 after vaccination, where Day 1 is the day of vaccination

    The safety analysis set consists of all subjects who are prescribed Pneumococcal 20-valent conjugate vaccine by the investigator in the routine care, received at least one dose of Pneumococcal 20-valent conjugate vaccine according to the approved product label in Korea, and have at least one safety follow-up.

  3. Frequency of Adverse Events (AEs)

    Time frame: 28 days after vaccination

    The safety analysis set consists of all subjects who are prescribed Pneumococcal 20-valent conjugate vaccine by the investigator in the routine care, received at least one dose of Pneumococcal 20-valent conjugate vaccine according to the approved product label in Korea, and have at least one safety follow-up.

  4. Frequency of Adverse Events Special Interest (AESI)

    Time frame: 28 days after vaccination

    The safety analysis set consists of all subjects who are prescribed Pneumococcal 20-valent conjugate vaccine by the investigator in the routine care, received at least one dose of Pneumococcal 20-valent conjugate vaccine according to the approved product label in Korea, and have at least one safety follow-up.

  5. Frequency of Adverse Drug Reactions (ADRs)

    Time frame: 28 days after vaccination

    The safety analysis set consists of all subjects who are prescribed Pneumococcal 20-valent conjugate vaccine by the investigator in the routine care, received at least one dose of Pneumococcal 20-valent conjugate vaccine according to the approved product label in Korea, and have at least one safety follow-up.

  6. Frequency of Serious Adverse Events (SAEs)

    Time frame: 28 days after vaccination

    The safety analysis set consists of all subjects who are prescribed Pneumococcal 20-valent conjugate vaccine by the investigator in the routine care, received at least one dose of Pneumococcal 20-valent conjugate vaccine according to the approved product label in Korea, and have at least one safety follow-up.

  7. Frequency of Serious Adverse Drug Reactions (SADRs)

    Time frame: 28 days after vaccination

    The safety analysis set consists of all subjects who are prescribed Pneumococcal 20-valent conjugate vaccine by the investigator in the routine care, received at least one dose of Pneumococcal 20-valent conjugate vaccine according to the approved product label in Korea, and have at least one safety follow-up.

  8. Frequency of Unexpected AEs

    Time frame: 28 days after vaccination

    The safety analysis set consists of all subjects who are prescribed Pneumococcal 20-valent conjugate vaccine by the investigator in the routine care, received at least one dose of Pneumococcal 20-valent conjugate vaccine according to the approved product label in Korea, and have at least one safety follow-up.

  9. Frequency of Unexpected ADRs

    Time frame: 28 days after vaccination

    The safety analysis set consists of all subjects who are prescribed Pneumococcal 20-valent conjugate vaccine by the investigator in the routine care, received at least one dose of Pneumococcal 20-valent conjugate vaccine according to the approved product label in Korea, and have at least one safety follow-up.

  10. Frequency of Unexpected SAEs

    Time frame: 28 days after vaccination

    The safety analysis set consists of all subjects who are prescribed Pneumococcal 20-valent conjugate vaccine by the investigator in the routine care, received at least one dose of Pneumococcal 20-valent conjugate vaccine according to the approved product label in Korea, and have at least one safety follow-up.

  11. Frequency of Unexpected SADRs

    Time frame: 28 days after vaccination

    The safety analysis set consists of all subjects who are prescribed Pneumococcal 20-valent conjugate vaccine by the investigator in the routine care, received at least one dose of Pneumococcal 20-valent conjugate vaccine according to the approved product label in Korea, and have at least one safety follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Korean Post-marketing Surveillance for Prevenar 20

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 6, 2025
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.