Post Market Surveillance to Observe Safety of Prevenar13™ in Adults

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

659 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-03-31

Brief Summary

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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).

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Detailed Description

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non-randomization, non-probability sampling

Conditions

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Pneumococcal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Korean adults aged 50 years and older who receive Prevenar13™ in a routine clinical setting

Non-intervention

Intervention Type BIOLOGICAL

Non-intervention

Interventions

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Non-intervention

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

* 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.