NCT06760208

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
660

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Nov 2025Mar 2027

First Submitted

Initial submission to the registry

December 29, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

November 13, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

December 29, 2024

Last Update Submit

March 10, 2026

Conditions

SafetyPneumococcal Immunization

Outcome Measures

Primary Outcomes (11)

  • Frequency of solicited systemic reactions

    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.

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

  • Frequency of solicited local reactions

    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.

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

  • Frequency of Adverse Events (AEs)

    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.

    28 days after vaccination

  • Frequency of Adverse Events Special Interest (AESI)

    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.

    28 days after vaccination

  • Frequency of Adverse Drug Reactions (ADRs)

    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.

    28 days after vaccination

  • Frequency of Serious Adverse Events (SAEs)

    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.

    28 days after vaccination

  • Frequency of Serious Adverse Drug Reactions (SADRs)

    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.

    28 days after vaccination

  • Frequency of Unexpected AEs

    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.

    28 days after vaccination

  • Frequency of Unexpected ADRs

    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.

    28 days after vaccination

  • Frequency of Unexpected SAEs

    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.

    28 days after vaccination

  • Frequency of Unexpected SADRs

    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.

    28 days after vaccination

Study Arms (1)

Pneumococcal 20-valent conjugate vaccine

Subjects aged 6 weeks or older who have been administered Pneumococcal 20-valent conjugate vaccine as per approved product label.

Biological: Pneumococcal 20-valent conjugate vaccine

Interventions

Pneumococcal 20-valent conjugate vaccineBIOLOGICAL

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.

Pneumococcal 20-valent conjugate vaccine

Eligibility Criteria

Age6 Weeks+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population for this study is subjects aged 6 weeks or older who are determined to be administered Pneumococcal 20-valent conjugate vaccine according to the approved indications in routine clinical practice in Republic of Korea.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Korea

Seoul, South Korea

RECRUITING

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2024

First Posted

January 6, 2025

Study Start

November 13, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Locations

KR(1)