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Post Market Surveillance to Observe Safety of Prevenar13™ in Adults

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
Chungnam National University Hospital (CNUH)
Jung-gu, Daejeon, 35015 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Subjects who are not indicated and/or contraindicated for the Prevenar13 usage will not be
included.

NCT01834222
Pfizer
Completed
Post Market Surveillance to Observe Safety of Prevenar13™ in Adults

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Post Market Surveillance to Observe Safety of Prevenar13? in Adults
Post Marketing Surveillance To Observe Safety Of Prevenar 13 In Adults
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).
non-randomization, non-probability sampling
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Korean adults aged 18 years and older who receive Prevenar13? in a routine clinical setting
Pneumococcal Disease
Biological: Non-intervention
Non-intervention
1
Korean adults aged 50 years and older who receive Prevenar13? in a routine clinical setting
Intervention: Biological: Non-intervention
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
659
March 2016
March 2016   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01834222
B1851143
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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