Clinical trial NCT01834222: Post Market Surveillance to Observe Safety of Prevenar13™ in Adults
Official title: Post Marketing Surveillance To Observe Safety Of Prevenar 13 In Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-04-17
Enrollment: 659
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Korean adults aged 18 years and older who receive Prevenar13™ in a routine clinical setting

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

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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline (Day 1) up to Day 29
measure: Duration of Adverse Events (AEs)
timeFrame: Baseline (Day 1) up to Day 29
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity
timeFrame: Baseline (Day 1) up to Day 29
measure: Number of Participants With Outcome in Response to Adverse Events (AEs)
timeFrame: Baseline (Day 1) up to Day 29
measure: Number of Participants Who Discontinued Due to Adverse Events (AEs)
timeFrame: Baseline (Day 1) up to Day 29
measure: Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug
timeFrame: Baseline (Day 1) up to Day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Jung-gu
country: Korea, Republic of
facility: Chungnam National University Hospital (CNUH)
state: Daejeon
city: Seongnam
country: Korea, Republic of
facility: Bundang 21st Clinic
state: Gyeonggi-do
city: Guro-gu
country: Korea, Republic of
facility: Lee soo yang Internal Medical Clinic
state: Seoul
city: Busan
country: Korea, Republic of
facility: Hansarang Internal Medicine Hospital
state: South Korea
city: Seoul
country: Korea, Republic of
facility: Shin Clinic Internal Medicine
state: South Korea
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daejeon
country: Korea, Republic of
facility: Samsung Happy Clinic
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Pusan National Univeristy Hospital
city: Daejeon
country: Korea, Republic of
facility: MiSo Medical
city: Daejeon
country: Korea, Republic of
facility: Sun's internal medicine
city: Daejeon
country: Korea, Republic of
facility: Techno Internal Medicine Clinic
city: Gangwon-do
country: Korea, Republic of
facility: Chuncheon Sacred Heart Hospital-Hallym University
city: GwangJu
country: Korea, Republic of
facility: Dr. Lee's Medical Clinic
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Suh Jeong Min Clinic
city: Gyeonggi-do
country: Korea, Republic of
facility: Bundang 21st Clinic
city: Gyeonggi-do
country: Korea, Republic of
facility: Light & Salt Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Seoul Samsung Medical Clinic
city: Seoul
country: Korea, Republic of
facility: Dr. Lee's Clinic of Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Sung's Medical Clinic
city: Seoul
country: Korea, Republic of
facility: GF Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Jong Koo Lee Heart Clinic
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: