Pneumococcal ImmunizationNCT06760208
A Study to Learn More About Prevenar 20 Once it is Out in the Korean Market
An observational study of Pneumococcal Immunization and Safety, run by Pfizer at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Immunization, Safety
- What is being tested?
- Pneumococcal 20-valent conjugate vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 660 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Nov 2025to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Korean Post-marketing Surveillance for Prevenar 20
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:
Read more
- 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.
Read the 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
- Being tested
- Pneumococcal 20-valent conjugate vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Pneumococcal 20-valent conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start13 Nov 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal ImmunizationStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760208
- Sponsor's protocol ID
- B7471038
- Status last verified
- Mar 2026
- First submitted
- 29 Dec 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korean Post-marketing Surveillance for Prevenar 20
- ClinicalTrials.gov ID
- NCT06760208
- Acronym / sponsor ID
- B7471038
- Conditions
- Pneumococcal Immunization, Safety
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pneumococcal 20-valent conjugate vaccine | – | Biological: Pneumococcal 20-valent conjugate vaccineSubjects aged 6 weeks or older who have been administered Pneumococcal 20-valent conjugate vaccine as per approved product label. |
Who may qualify
- Ages
- 6 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumococcal 20-valent conjugate vaccineFor 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. | Biological | Pneumococcal 20-valent conjugate vaccine |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Immunization and Safety, run by Pfizer at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of solicited systemic reactions (time frame: From Day 1 through Day 7 after vaccination, where Day 1 is the day of vaccination). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.