A Study to Learn More About Prevenar 20 Once it is Out in the Korean Market
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorPfizer
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Pneumococcal 20-valent conjugate vaccine
Biological/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.
Treatment groups
660 Participants
are divided into 1 treatment groupGroup A: Pneumococcal 20-valent conjugate vaccine1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From Day 1 through Day 7 after vaccination, where Day 1 is the day of vaccination2
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.
Time frame
From Day 1 through Day 10 after vaccination, where Day 1 is the day of vaccination3
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.
Time frame
28 days after vaccination4
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.
Time frame
28 days after vaccination Source ClinicalTrials.gov