Post Market Surveillance to Observe Safety of Prevenar13™ in Adults

Pfizer

Status: Completed

Conditions: Pneumococcal Disease

Treatments: Biological: Non-intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01834222

B1851143

Details and patient eligibility

About

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).

Full description

non-randomization, non-probability sampling

Enrollment: 659 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

659 participants in 1 patient group

1

Description:

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

Treatment:

Biological: Non-intervention