Post Market Surveillance to Observe Safety of Prevenar13™ in Adults

March 6, 2017 updated by: Pfizer

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

non-randomization, non-probability sampling

Study Type

Observational

Enrollment (Actual)

659

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Hospital
      • Daejeon, Korea, Republic of, 301-721
        • Chungnam National University Hospital
      • Daejeon, Korea, Republic of, 300-826
        • Samsung Happy Clinic
      • Daejeon, Korea, Republic of, 301-812
        • Pusan National Univeristy Hospital
      • Daejeon, Korea, Republic of, 302-120
        • MiSo Medical
      • Daejeon, Korea, Republic of, 305-509
        • Sun's internal medicine
      • Daejeon, Korea, Republic of, 305-509
        • Techno Internal Medicine Clinic
      • Gangwon-do, Korea, Republic of, 24253
        • Chuncheon Sacred Heart Hospital-Hallym University
      • GwangJu, Korea, Republic of, 501-190
        • Dr. Lee's Medical Clinic
      • Gwangju, Korea, Republic of, 501-757
        • Chonnam National University Hospital
      • Gwangju, Korea, Republic of, 61469
        • Chonnam National University Hospital
      • Gyeonggi-do, Korea, Republic of, 441-885
        • Suh Jeong Min Clinic
      • Gyeonggi-do, Korea, Republic of, 463-823
        • Bundang 21st Clinic
      • Gyeonggi-do, Korea, Republic of
        • Light & Salt Internal Medicine
      • Seoul, Korea, Republic of, 122-823
        • Seoul Samsung Medical Clinic
      • Seoul, Korea, Republic of, 139-716
        • Dr. Lee's Clinic of Internal Medicine
      • Seoul, Korea, Republic of, 153-806
        • Sung's Medical Clinic
      • Seoul, Korea, Republic of
        • GF Internal Medicine
      • Seoul, Korea, Republic of
        • Jong Koo Lee Heart Clinic
      • Ulsan, Korea, Republic of, 682-714
        • Ulsan University Hospital
    • Daejeon
      • Jung-gu, Daejeon, Korea, Republic of, 35015
        • Chungnam National University Hospital (CNUH)
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 463-823
        • Bundang 21st Clinic
    • Seoul
      • Guro-gu, Seoul, Korea, Republic of, 152-893
        • Lee soo yang Internal Medical Clinic
    • South Korea
      • Busan, South Korea, Korea, Republic of, 616-820
        • Hansarang Internal Medicine Hospital
      • Seoul, South Korea, Korea, Republic of, 135-830
        • Shin Clinic Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Korean adults aged 18 years and older who receive Prevenar13™ in a routine clinical setting

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Korean adults aged 50 years and older who receive Prevenar13™ in a routine clinical setting
Biological: Non-intervention
Non-intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline (Day 1) up to Day 29
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (up to Day 29) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AE.
Baseline (Day 1) up to Day 29
Duration of Adverse Events (AEs)
Time Frame: Baseline (Day 1) up to Day 29
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of adverse event (in days) was defined as total time from onset of adverse event till the event was resolved during study.
Baseline (Day 1) up to Day 29
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity
Time Frame: Baseline (Day 1) up to Day 29
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed on basis of severity as follows: a) mild: did not caused any significant problem to the participant; b) moderate: caused problem that did not interfere significantly with usual activities or the clinical status, other therapy needed due to AE; c) severe: caused problem that interfered significantly with usual activities or the clinical status.
Baseline (Day 1) up to Day 29
Number of Participants With Outcome in Response to Adverse Events (AEs)
Time Frame: Baseline (Day 1) up to Day 29
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was assessed among participants based on their response to a question 'Is the adverse event still present?' as 'yes', 'unknown' or 'no (resolved)' during study.
Baseline (Day 1) up to Day 29
Number of Participants Who Discontinued Due to Adverse Events (AEs)
Time Frame: Baseline (Day 1) up to Day 29
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Baseline (Day 1) up to Day 29
Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug
Time Frame: Baseline (Day 1) up to Day 29
Criteria: a)Certain: followed a reasonable time sequence from administration of drug; unexplained by other drugs, chemical substance or accompanying diseases;had clinically reasonable reaction on cessation of drug; had pharmacological or phenomenological reaction to re-administration of drug, b)Probable: followed a reasonable time sequence from administration of the drug; unexplained by other drugs;chemical substance or accompanying diseases; had clinically reasonable reaction on cessation of the drug, c)Possible:followed a reasonable time sequence from administration of drug; can also be explained by other drugs;chemical substance or accompanying diseases; lacks information or had unclear information on discontinuation of drug, d)Unlikely:not likely to had a reasonable causal relationship from administration of drug; seemed temporary; can also be reasonably explained by other drugs; chemical substances or latent diseases; conditional (need more data for true assessment),unaccessible.
Baseline (Day 1) up to Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

April 12, 2013

First Submitted That Met QC Criteria

April 12, 2013

First Posted (Estimate)

April 17, 2013

Study Record Updates

Last Update Posted (Actual)

April 18, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1851143

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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