Post Market Surveillance to Observe Safety of Prevenar13™ in Adults
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| ClinicalTrials.gov Identifier: NCT01834222 |
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Recruitment Status :
Completed
First Posted : April 17, 2013
Results First Posted : April 18, 2017
Last Update Posted : April 18, 2017
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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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 |
|---|---|
| Pneumococcal Disease | Biological: Non-intervention |
| Study Type : | Observational |
| Actual Enrollment : | 659 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Post Marketing Surveillance To Observe Safety Of Prevenar 13 In Adults |
| Study Start Date : | December 2013 |
| Actual Primary Completion Date : | March 2016 |
| Actual Study Completion Date : | March 2016 |
| Group/Cohort | Intervention/treatment |
|---|---|
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1
Korean adults aged 50 years and older who receive Prevenar13™ in a routine clinical setting
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Biological: Non-intervention
Non-intervention |
Primary Outcome Measures :
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Korean adults aged 18 years and older who receive Prevenar13™ in a routine clinical setting
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834222
Locations
Show 27 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01834222 |
| Other Study ID Numbers: |
B1851143 |
| First Posted: | April 17, 2013 Key Record Dates |
| Results First Posted: | April 18, 2017 |
| Last Update Posted: | April 18, 2017 |
| Last Verified: | March 2017 |
Additional relevant MeSH terms:
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Pneumococcal Infections Streptococcal Infections Gram-Positive Bacterial Infections |
Bacterial Infections Bacterial Infections and Mycoses Infections |