Completed

Post Marketing Surveillance To Observe Safety Of Prevenar 13 In Adults

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Biological Data

Collected from today forward - Prospective
Biological
Who is being recruted

Bacterial Infections and Mycoses+3

+ Bacterial Infections

+ Infections

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: December 2013
See protocol details

Summary

Principal SponsorPfizer
Last updated: April 18, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2013

Actual date on which the first participant was enrolled.

non-randomization, non-probability sampling

NCT01834222
Principal SponsorPfizer
Last updated: April 18, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

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

659 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bacterial Infections and MycosesBacterial InfectionsInfectionsStreptococcal InfectionsGram-Positive Bacterial InfectionsPneumococcal Infections

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 27 locations

Chungnam National University Hospital (CNUH)

Jung-gu, South KoreaOpen Chungnam National University Hospital (CNUH) in Google Maps

Bundang 21st Clinic

Seongnam-si, South Korea

Lee soo yang Internal Medical Clinic

Guro-gu, South Korea

Hansarang Internal Medicine Hospital

Busan, South Korea
Completed27 Study Centers