Post Market Surveillance to Observe Safety of Prevenar13™ in Adults
- Conditions
- Pneumococcal Disease
- Interventions
- Biological: Non-intervention
- Registration Number
- NCT01834222
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to assess safety profile of Prevenar 13™ when used among Korean adults in the routine clinical setting, as required for any new drug approved by Korea Food and Drug Administration (KFDA).
- Detailed Description
non-randomization, non-probability sampling
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 659
Korean adults aged 18 years and older; provided the conditions pertaining to contraindications, warnings, precautions, and interactions stated in the local product document do not apply.
- Evidence of a personally signed and dated informed consent document indicating that the subject(or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Subjects who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Non-intervention Korean adults aged 50 years and older who receive Prevenar13™ in a routine clinical setting
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity Baseline (Day 1) up to Day 29 An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed on basis of severity as follows: a) mild: did not caused any significant problem to the participant; b) moderate: caused problem that did not interfere significantly with usual activities or the clinical status, other therapy needed due to AE; c) severe: caused problem that interfered significantly with usual activities or the clinical status.
Number of Participants With Outcome in Response to Adverse Events (AEs) Baseline (Day 1) up to Day 29 An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was assessed among participants based on their response to a question 'Is the adverse event still present?' as 'yes', 'unknown' or 'no (resolved)' during study.
Number of Participants Who Discontinued Due to Adverse Events (AEs) Baseline (Day 1) up to Day 29 An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline (Day 1) up to Day 29 An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (up to Day 29) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AE.
Duration of Adverse Events (AEs) Baseline (Day 1) up to Day 29 An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of adverse event (in days) was defined as total time from onset of adverse event till the event was resolved during study.
Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug Baseline (Day 1) up to Day 29 Criteria: a)Certain: followed a reasonable time sequence from administration of drug; unexplained by other drugs, chemical substance or accompanying diseases;had clinically reasonable reaction on cessation of drug; had pharmacological or phenomenological reaction to re-administration of drug, b)Probable: followed a reasonable time sequence from administration of the drug; unexplained by other drugs;chemical substance or accompanying diseases; had clinically reasonable reaction on cessation of the drug, c)Possible:followed a reasonable time sequence from administration of drug; can also be explained by other drugs;chemical substance or accompanying diseases; lacks information or had unclear information on discontinuation of drug, d)Unlikely:not likely to had a reasonable causal relationship from administration of drug; seemed temporary; can also be reasonably explained by other drugs; chemical substances or latent diseases; conditional (need more data for true assessment),unaccessible.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Bundang 21st Clinic
🇰🇷Gyeonggi-do, Korea, Republic of
Hansarang Internal Medicine Hospital
🇰🇷Busan, South Korea, Korea, Republic of
Shin Clinic Internal Medicine
🇰🇷Seoul, South Korea, Korea, Republic of
Techno Internal Medicine Clinic
🇰🇷Daejeon, Korea, Republic of
Suh Jeong Min Clinic
🇰🇷Gyeonggi-do, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Chungnam National University Hospital (CNUH)
🇰🇷Jung-gu, Daejeon, Korea, Republic of
Samsung Happy Clinic
🇰🇷Daejeon, Korea, Republic of
Lee soo yang Internal Medical Clinic
🇰🇷Guro-gu, Seoul, Korea, Republic of
Pusan National Univeristy Hospital
🇰🇷Daejeon, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
MiSo Medical
🇰🇷Daejeon, Korea, Republic of
Chuncheon Sacred Heart Hospital-Hallym University
🇰🇷Gangwon-do, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Dr. Lee's Medical Clinic
🇰🇷GwangJu, Korea, Republic of
Sun's internal medicine
🇰🇷Daejeon, Korea, Republic of
Seoul Samsung Medical Clinic
🇰🇷Seoul, Korea, Republic of
Dr. Lee's Clinic of Internal Medicine
🇰🇷Seoul, Korea, Republic of
Light & Salt Internal Medicine
🇰🇷Gyeonggi-do, Korea, Republic of
Sung's Medical Clinic
🇰🇷Seoul, Korea, Republic of
Jong Koo Lee Heart Clinic
🇰🇷Seoul, Korea, Republic of
GF Internal Medicine
🇰🇷Seoul, Korea, Republic of