Pneumococcal Disease
Conditions
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
Interventions
BIOLOGICALNon-intervention
Non-intervention
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 658 |
| Total | 658 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not meet inclusion/exclusion criteria | 1 |
Baseline characteristics
| Characteristic | Prevenar 13 |
|---|---|
| Age, Continuous | 58.81 years STANDARD_DEVIATION 11.53 |
| Sex: Female, Male Female | 337 Participants |
| Sex: Female, Male Male | 321 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 139 / 658 |
| serious Total, serious adverse events | 2 / 658 |
Outcome results
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.
Time frame: Baseline (Day 1) up to Day 29
Population: Safety analysis set included all participants who received at least 1 dose of Prevenar 13.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prevenar 13 | Duration of Adverse Events (AEs) | 4.89 days | Standard Deviation 7.22 |
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.
Time frame: Baseline (Day 1) up to Day 29
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13 | Number of Participants Who Discontinued Due to Adverse Events (AEs) | 0 participants |
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.
Time frame: Baseline (Day 1) up to Day 29
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13 | Number of Participants With Outcome in Response to Adverse Events (AEs) | No (Resolved) | 132 participants |
| Prevenar 13 | Number of Participants With Outcome in Response to Adverse Events (AEs) | Yes | 3 participants |
| Prevenar 13 | Number of Participants With Outcome in Response to Adverse Events (AEs) | Unknown | 5 participants |
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.
Time frame: Baseline (Day 1) up to Day 29
Population: Safety analysis set included all participants who received at least 1 dose of Prevenar 13.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13 | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 140 participants |
| Prevenar 13 | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 2 participants |
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.
Time frame: Baseline (Day 1) up to Day 29
Population: Safety analysis set included all participants who received at least 1 dose of Prevenar 13.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13 | Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity | Mild | 127 participants |
| Prevenar 13 | Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity | Moderate | 17 participants |
| Prevenar 13 | Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity | Severe | 2 participants |
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.
Time frame: Baseline (Day 1) up to Day 29
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13 | Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug | Certain | 47.60 percentage of adverse events |
| Prevenar 13 | Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug | Probable | 24.04 percentage of adverse events |
| Prevenar 13 | Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug | Possible | 20.67 percentage of adverse events |
| Prevenar 13 | Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug | Unlikely | 7.69 percentage of adverse events |