N/A
Completed N=659
Post Market Surveillance to Observe Safety of Prevenar13™ in Adults
Source: ClinicalTrials.gov NCT01834222 ↗Enrolled (actual)
659
Serious AEs
0.3%
Results posted
Apr 2017
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 140; 2 participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
140; 2 | — |
| PRIMARY Duration of Adverse Events (AEs) |
4.89 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity |
127; 17; 2 | — |
| PRIMARY Number of Participants With Outcome in Response to Adverse Events (AEs) |
132; 3; 5 | — |
| PRIMARY Number of Participants Who Discontinued Due to Adverse Events (AEs) |
— | — |
| PRIMARY Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug |
47.60; 24.04; 20.67; 7.69 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01834222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.