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NCT01834222 Clinical Trial

Post Market Surveillance to Observe Safety of Prevenar13™ in Adults

Pneumococcal Disease Clinical Trial

Official title:
Post Marketing Surveillance To Observe Safety Of Prevenar 13 In Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01834222
Other study ID # B1851143
Secondary ID
Status Completed
Phase N/A
First received April 12, 2013
Last updated July 20, 2016
Start date December 2013
Est. completion date March 2016

Study information
Verified date July 2016
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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).

Description:

non-randomization, non-probability sampling

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Biological:
• Non-intervention
Non-intervention

Locations
Country Name City State
Korea, Republic of Hansarang Internal Medicine Hospital Busan South Korea
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Keimyung University Dongsan Hospital Daegu
Korea, Republic of MiSo Medical Daejeon
Korea, Republic of Pusan National Univeristy Hospital Daejeon
Korea, Republic of Samsung Happy Clinic Daejeon
Korea, Republic of Sun's internal medicine Daejeon
Korea, Republic of Techno Internal Medicine Clinic Daejeon
Korea, Republic of Seo Moon Medical Clinic Dongjak-Gu Seoul
Korea, Republic of Chuncheon Sacred Heart Hospital-Hallym University Gangwon-do
Korea, Republic of Lee soo yang Internal Medical Clinic Guro-gu Seoul
Korea, Republic of Chonnam National University Hospital Gwangju
Korea, Republic of Chonnam National University Hospital Gwangju
Korea, Republic of Dr. Lee's Medical Clinic GwangJu
Korea, Republic of Light & Salt Internal Medicine Gyeonggi-do
Korea, Republic of Chungnam National University Hospital (CNUH) Jung-gu Daejeon
Korea, Republic of Bundang 21st Clinic Seongnam Gyeonggi-do
Korea, Republic of Dr. Lee's Clinic of Internal Medicine Seoul
Korea, Republic of GF Internal Medicine Seoul
Korea, Republic of Jong Koo Lee Heart Clinic Seoul
Korea, Republic of Seoul Samsung Medical Clinic Seoul
Korea, Republic of Shin Clinic Internal Medicine Seoul South Korea
Korea, Republic of Sung's Medical Clinic Seoul
Korea, Republic of Ulsan University Hospital Ulsan

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety profile following administration of Prevenar13- Clinical nature, frequency, duration, severity of adverse events; discontinuation due to adverse events; outcome and possible causality 28 days Yes
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