Post Market Surveillance to Observe Safety of Prevenar13™ in Adults
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Detailed Description
non-randomization, non-probability sampling
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
1 Korean adults aged 50 years and older who receive Prevenar13™ in a routine clinical setting |
Biological: Non-intervention
Non-intervention
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
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.
- 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.
Exclusion Criteria:
Subjects who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Chungnam National University Hospital (CNUH) | Jung-gu | Daejeon | Korea, Republic of | 35015 |
2 | Bundang 21st Clinic | Seongnam | Gyeonggi-do | Korea, Republic of | 463-823 |
3 | Lee soo yang Internal Medical Clinic | Guro-gu | Seoul | Korea, Republic of | 152-893 |
4 | Hansarang Internal Medicine Hospital | Busan | South Korea | Korea, Republic of | 616-820 |
5 | Shin Clinic Internal Medicine | Seoul | South Korea | Korea, Republic of | 135-830 |
6 | Pusan National University Hospital | Busan | Korea, Republic of | 49241 | |
7 | Pusan National University Hospital | Busan | Korea, Republic of | 602-739 | |
8 | Keimyung University Dongsan Hospital | Daegu | Korea, Republic of | 41931 | |
9 | Samsung Happy Clinic | Daejeon | Korea, Republic of | 300-826 | |
10 | Chungnam National University Hospital | Daejeon | Korea, Republic of | 301-721 | |
11 | Pusan National Univeristy Hospital | Daejeon | Korea, Republic of | 301-812 | |
12 | MiSo Medical | Daejeon | Korea, Republic of | 302-120 | |
13 | Sun's internal medicine | Daejeon | Korea, Republic of | 305-509 | |
14 | Techno Internal Medicine Clinic | Daejeon | Korea, Republic of | 305-509 | |
15 | Chuncheon Sacred Heart Hospital-Hallym University | Gangwon-do | Korea, Republic of | 24253 | |
16 | Dr. Lee's Medical Clinic | GwangJu | Korea, Republic of | 501-190 | |
17 | Chonnam National University Hospital | Gwangju | Korea, Republic of | 501-757 | |
18 | Chonnam National University Hospital | Gwangju | Korea, Republic of | 61469 | |
19 | Suh Jeong Min Clinic | Gyeonggi-do | Korea, Republic of | 441-885 | |
20 | Bundang 21st Clinic | Gyeonggi-do | Korea, Republic of | 463-823 | |
21 | Light & Salt Internal Medicine | Gyeonggi-do | Korea, Republic of | ||
22 | Seoul Samsung Medical Clinic | Seoul | Korea, Republic of | 122-823 | |
23 | Dr. Lee's Clinic of Internal Medicine | Seoul | Korea, Republic of | 139-716 | |
24 | Sung's Medical Clinic | Seoul | Korea, Republic of | 153-806 | |
25 | GF Internal Medicine | Seoul | Korea, Republic of | ||
26 | Jong Koo Lee Heart Clinic | Seoul | Korea, Republic of | ||
27 | Ulsan University Hospital | Ulsan | Korea, Republic of | 682-714 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- B1851143
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Prevenar 13 |
---|---|
Arm/Group Description | 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. |
Period Title: Overall Study | |
STARTED | 659 |
Treated | 658 |
COMPLETED | 658 |
NOT COMPLETED | 1 |
Baseline Characteristics
Arm/Group Title | Prevenar 13 |
---|---|
Arm/Group Description | 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. |
Overall Participants | 658 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
58.81
(11.53)
|
Sex: Female, Male (Count of Participants) | |
Female |
337
51.2%
|
Male |
321
48.8%
|
Outcome Measures
Title | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
---|---|
Description | 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. |
Time Frame | Baseline (Day 1) up to Day 29 |
Outcome Measure Data
Analysis Population Description |
---|
Safety analysis set included all participants who received at least 1 dose of Prevenar 13. |
Arm/Group Title | Prevenar 13 |
---|---|
Arm/Group Description | 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. |
Measure Participants | 658 |
AEs |
140
21.3%
|
SAEs |
2
0.3%
|
Title | Duration of Adverse Events (AEs) |
---|---|
Description | 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. |
Time Frame | Baseline (Day 1) up to Day 29 |
Outcome Measure Data
Analysis Population Description |
---|
Safety analysis set included all participants who received at least 1 dose of Prevenar 13. |
Arm/Group Title | Prevenar 13 |
---|---|
Arm/Group Description | 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. |
Measure Participants | 658 |
Mean (Standard Deviation) [days] |
4.89
(7.22)
|
Title | Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity |
---|---|
Description | 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. |
Time Frame | Baseline (Day 1) up to Day 29 |
Outcome Measure Data
Analysis Population Description |
---|
Safety analysis set included all participants who received at least 1 dose of Prevenar 13. |
Arm/Group Title | Prevenar 13 |
---|---|
Arm/Group Description | 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. |
Measure Participants | 658 |
Mild |
127
19.3%
|
Moderate |
17
2.6%
|
Severe |
2
0.3%
|
Title | Number of Participants With Outcome in Response to Adverse Events (AEs) |
---|---|
Description | 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. |
Time Frame | Baseline (Day 1) up to Day 29 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Prevenar 13 |
---|---|
Arm/Group Description | 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. |
Measure Participants | 140 |
No (Resolved) |
132
20.1%
|
Yes |
3
0.5%
|
Unknown |
5
0.8%
|
Title | Number of Participants Who Discontinued Due to Adverse Events (AEs) |
---|---|
Description | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
Time Frame | Baseline (Day 1) up to Day 29 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Prevenar 13 |
---|---|
Arm/Group Description | 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. |
Measure Participants | 140 |
Number [participants] |
0
0%
|
Title | Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug |
---|---|
Description | 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. |
Time Frame | Baseline (Day 1) up to Day 29 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Prevenar 13 |
---|---|
Arm/Group Description | 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. |
Measure Participants | 140 |
Certain |
47.60
|
Probable |
24.04
|
Possible |
20.67
|
Unlikely |
7.69
|
Adverse Events
Time Frame | ||
---|---|---|
Adverse Event Reporting Description | 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. | |
Arm/Group Title | Prevenar 13 | |
Arm/Group Description | 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. | |
All Cause Mortality |
||
Prevenar 13 | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Prevenar 13 | ||
Affected / at Risk (%) | # Events | |
Total | 2/658 (0.3%) | |
Gastrointestinal disorders | ||
INTESTINAL OBSTRUCTION | 1/658 (0.2%) | |
VOMITING | 1/658 (0.2%) | |
Infections and infestations | ||
INFECTION VIRAL | 1/658 (0.2%) | |
Other (Not Including Serious) Adverse Events |
||
Prevenar 13 | ||
Affected / at Risk (%) | # Events | |
Total | 139/658 (21.1%) | |
Blood and lymphatic system disorders | ||
LEUCOPENIA | 1/658 (0.2%) | |
Gastrointestinal disorders | ||
DYSPEPSIA | 1/658 (0.2%) | |
GASTRIC ULCER | 1/658 (0.2%) | |
GASTROENTERITIS | 1/658 (0.2%) | |
General disorders | ||
INJECTION SITE PAIN | 79/658 (12%) | |
INJECTION SITE PRURITUS | 12/658 (1.8%) | |
INJECTION SITE REACTION | 35/658 (5.3%) | |
INJECTION SITE URTICARIA | 1/658 (0.2%) | |
ALLERGIC REACTION | 1/658 (0.2%) | |
FEVER | 25/658 (3.8%) | |
RIGORS | 2/658 (0.3%) | |
Infections and infestations | ||
CELLULITIS | 5/658 (0.8%) | |
HERPES ZOSTER | 1/658 (0.2%) | |
PHARYNGITIS | 1/658 (0.2%) | |
UPPER RESPIRATORY TRACT INFECTION | 1/658 (0.2%) | |
URINARY TRACT INFECTION | 1/658 (0.2%) | |
Investigations | ||
C-REACTIVE PROTEIN INCREASED | 1/658 (0.2%) | |
Musculoskeletal and connective tissue disorders | ||
BACK PAIN | 1/658 (0.2%) | |
MYALGIA | 21/658 (3.2%) | |
Nervous system disorders | ||
MIGRAINE | 1/658 (0.2%) | |
Respiratory, thoracic and mediastinal disorders | ||
COUGHING | 2/658 (0.3%) | |
Skin and subcutaneous tissue disorders | ||
URTICARIA | 1/658 (0.2%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Pfizer ClinicalTrials.gov Call Center |
---|---|
Organization | Pfizer, Inc. |
Phone | 001-800-718-1021 |
ClinicalTrials.gov_Inquiries@pfizer.com |
- B1851143