Clinical trial NCT06760208: A Study to Learn More About Prevenar 20 Once it is Out in the Korean Market
Official title: Korean Post-marketing Surveillance for Prevenar 20
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pneumococcal Immunization
Safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2025-01-06
Enrollment: 660
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Frequency of solicited systemic reactions
timeFrame: From Day 1 through Day 7 after vaccination, where Day 1 is the day of vaccination
measure: Frequency of solicited local reactions
timeFrame: From Day 1 through Day 10 after vaccination, where Day 1 is the day of vaccination
measure: Frequency of Adverse Events (AEs)
timeFrame: 28 days after vaccination
measure: Frequency of Adverse Events Special Interest (AESI)
timeFrame: 28 days after vaccination
measure: Frequency of Adverse Drug Reactions (ADRs)
timeFrame: 28 days after vaccination
measure: Frequency of Serious Adverse Events (SAEs)
timeFrame: 28 days after vaccination
measure: Frequency of Serious Adverse Drug Reactions (SADRs)
timeFrame: 28 days after vaccination
measure: Frequency of Unexpected AEs
timeFrame: 28 days after vaccination
measure: Frequency of Unexpected ADRs
timeFrame: 28 days after vaccination
measure: Frequency of Unexpected SAEs
timeFrame: 28 days after vaccination
measure: Frequency of Unexpected SADRs
timeFrame: 28 days after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer Korea
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: