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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).
non-randomization, non-probability sampling
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Korean adults aged 50 years and older who receive Prevenar13™ in a routine clinical setting |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-intervention | Biological | Non-intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Baseline (Day 1) up to Day 29 |
| Duration of Adverse Events (AEs) | 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. | Baseline (Day 1) up to Day 29 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity | 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. | Baseline (Day 1) up to Day 29 |
| Number of Participants With Outcome in Response to Adverse Events (AEs) | 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. |
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Inclusion Criteria:
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.
Exclusion Criteria:
Subjects who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.
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Korean adults aged 18 years and older who receive Prevenar13™ in a routine clinical setting
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital (CNUH) | Jung-gu | Daejeon | 35015 | South Korea | ||
| Bundang 21st Clinic |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prevenar 13 | Participants received single dose of Prevenar 13 vaccine, 0.5 milliliter (mL) intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline (Day 1) up to Day 29 |
| Number of Participants Who Discontinued Due to Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Baseline (Day 1) up to Day 29 |
| Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug | 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. | Baseline (Day 1) up to Day 29 |
| Seongnam-si |
| Gyeonggi-do |
| 463-823 |
| South Korea |
| Lee soo yang Internal Medical Clinic | Guro-gu | Seoul | 152-893 | South Korea |
| Hansarang Internal Medicine Hospital | Busan | South Korea | 616-820 | South Korea |
| Shin Clinic Internal Medicine | Seoul | South Korea | 135-830 | South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Pusan National University Hospital | Busan | 602-739 | South Korea |
| Keimyung University Dongsan Hospital | Daegu | 41931 | South Korea |
| Samsung Happy Clinic | Daejeon | 300-826 | South Korea |
| Chungnam National University Hospital | Daejeon | 301-721 | South Korea |
| Pusan National Univeristy Hospital | Daejeon | 301-812 | South Korea |
| MiSo Medical | Daejeon | 302-120 | South Korea |
| Sun's internal medicine | Daejeon | 305-509 | South Korea |
| Techno Internal Medicine Clinic | Daejeon | 305-509 | South Korea |
| Chuncheon Sacred Heart Hospital-Hallym University | Gangwon-do | 24253 | South Korea |
| Dr. Lee's Medical Clinic | Gwangju | 501-190 | South Korea |
| Chonnam National University Hospital | Gwangju | 501-757 | South Korea |
| Chonnam National University Hospital | Gwangju | 61469 | South Korea |
| Suh Jeong Min Clinic | Gyeonggi-do | 441-885 | South Korea |
| Bundang 21st Clinic | Gyeonggi-do | 463-823 | South Korea |
| Light & Salt Internal Medicine | Gyeonggi-do | South Korea |
| Seoul Samsung Medical Clinic | Seoul | 122-823 | South Korea |
| Dr. Lee's Clinic of Internal Medicine | Seoul | 139-716 | South Korea |
| Sung's Medical Clinic | Seoul | 153-806 | South Korea |
| GF Internal Medicine | Seoul | South Korea |
| Jong Koo Lee Heart Clinic | Seoul | South Korea |
| Ulsan University Hospital | Ulsan | 682-714 | South Korea |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set included all participants who received at least 1 dose of Prevenar 13.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prevenar 13 | Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Safety analysis set included all participants who received at least 1 dose of Prevenar 13. | Posted | Number | participants | Baseline (Day 1) up to Day 29 |
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| Primary | Duration of Adverse Events (AEs) | 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. | Safety analysis set included all participants who received at least 1 dose of Prevenar 13. | Posted | Mean | Standard Deviation | days | Baseline (Day 1) up to Day 29 |
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| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity | 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. | Safety analysis set included all participants who received at least 1 dose of Prevenar 13. | Posted | Number | participants | Baseline (Day 1) up to Day 29 |
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| Primary | Number of Participants With Outcome in Response to Adverse Events (AEs) | 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. | Safety analysis set included all participants who received at least 1 dose of Prevenar 13. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | Baseline (Day 1) up to Day 29 |
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| Primary | Number of Participants Who Discontinued Due to Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Safety analysis set included all participants who received at least 1 dose of Prevenar 13. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | Baseline (Day 1) up to Day 29 |
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| Primary | Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug | 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. | Safety analysis set included all participants who received at least 1 dose of Prevenar 13. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of adverse events | Baseline (Day 1) up to Day 29 |
|
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The same event may appear as both AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experience both a serious and non-serious event during the study. Analysis was performed on safety analysis set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prevenar 13 | Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination. | 2 | 658 | 139 | 658 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | WHO-ART 092 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | WHO-ART 092 | Systematic Assessment |
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| INFECTION VIRAL | Infections and infestations | WHO-ART 092 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CELLULITIS | Infections and infestations | WHO-ART 092 | Systematic Assessment |
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| INJECTION SITE PAIN | General disorders | WHO-ART 092 | Systematic Assessment |
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| INJECTION SITE PRURITUS | General disorders | WHO-ART 092 | Systematic Assessment |
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| INJECTION SITE REACTION | General disorders | WHO-ART 092 | Systematic Assessment |
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| INJECTION SITE URTICARIA | General disorders | WHO-ART 092 | Systematic Assessment |
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| ALLERGIC REACTION | General disorders | WHO-ART 092 | Systematic Assessment |
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| C-REACTIVE PROTEIN INCREASED | Investigations | WHO-ART 092 | Systematic Assessment |
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| FEVER | General disorders | WHO-ART 092 | Systematic Assessment |
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| RIGORS | General disorders | WHO-ART 092 | Systematic Assessment |
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| MIGRAINE | Nervous system disorders | WHO-ART 092 | Non-systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | WHO-ART 092 | Systematic Assessment |
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| GASTRIC ULCER | Gastrointestinal disorders | WHO-ART 092 | Systematic Assessment |
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| GASTROENTERITIS | Gastrointestinal disorders | WHO-ART 092 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | WHO-ART 092 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | WHO-ART 092 | Systematic Assessment |
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| HERPES ZOSTER | Infections and infestations | WHO-ART 092 | Systematic Assessment |
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| PHARYNGITIS | Infections and infestations | WHO-ART 092 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | WHO-ART 092 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | WHO-ART 092 | Systematic Assessment |
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| COUGHING | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Systematic Assessment |
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| URTICARIA | Skin and subcutaneous tissue disorders | WHO-ART 092 | Systematic Assessment |
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| LEUCOPENIA | Blood and lymphatic system disorders | WHO-ART 092 | Systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 001-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Units | Counts |
|---|---|
| Participants |
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