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Post Market Surveillance to Observe Safety of Prevenar13™ in Adults

Last updated on March 23, 2020

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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Descriptive Information
Brief Title Post Market Surveillance to Observe Safety of Prevenar13? in Adults
Official Title Post Marketing Surveillance To Observe Safety Of Prevenar 13 In Adults
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).
Detailed Description non-randomization, non-probability sampling
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Korean adults aged 18 years and older who receive Prevenar13? in a routine clinical setting
Condition Pneumococcal Disease
Intervention Biological: Non-intervention
Non-intervention
Study Groups/Cohorts 1
Korean adults aged 50 years and older who receive Prevenar13? in a routine clinical setting
Intervention: Biological: Non-intervention
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 6, 2017)
659
Original Estimated Enrollment
 (submitted: April 12, 2013)
600
Actual Study Completion Date March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01834222
Other Study ID Numbers B1851143
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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