Post Market Surveillance to Observe Safety of Prevenar13™ in Adults

NCT01834222 | Completed Results

• 1 other identifier: B1851143
• Study Type: observational
• Target: 659
• Locations: 1 country
• Sites: 27

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).

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (6)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  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)

  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

  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)

  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)

  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

  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

Study Arms (1)

1

Korean adults aged 50 years and older who receive Prevenar13™ in a routine clinical setting

Biological: Non-intervention

Interventions

Non-intervention BIOLOGICAL

Non-intervention

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Subjects who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (27)

Chungnam National University Hospital (CNUH)

Jung-gu, Daejeon, 35015, South Korea

Location

Bundang 21st Clinic

Seongnam-si, Gyeonggi-do, 463-823, South Korea

Location

Lee soo yang Internal Medical Clinic

Guro-gu, Seoul, 152-893, South Korea

Location

Hansarang Internal Medicine Hospital

Busan, South Korea, 616-820, South Korea

Location

Shin Clinic Internal Medicine

Seoul, South Korea, 135-830, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Pusan National University Hospital

Busan, 602-739, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, 41931, South Korea

Location

Samsung Happy Clinic

Daejeon, 300-826, South Korea

Location

Chungnam National University Hospital

Daejeon, 301-721, South Korea

Location

Pusan National Univeristy Hospital

Daejeon, 301-812, South Korea

Location

MiSo Medical

Daejeon, 302-120, South Korea

Location

Sun's internal medicine

Daejeon, 305-509, South Korea

Location

Techno Internal Medicine Clinic

Daejeon, 305-509, South Korea

Location

Chuncheon Sacred Heart Hospital-Hallym University

Gangwon-do, 24253, South Korea

Location

Dr. Lee's Medical Clinic

Gwangju, 501-190, South Korea

Location

Chonnam National University Hospital

Gwangju, 501-757, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Suh Jeong Min Clinic

Gyeonggi-do, 441-885, South Korea

Location

Bundang 21st Clinic

Gyeonggi-do, 463-823, South Korea

Location

Light & Salt Internal Medicine

Gyeonggi-do, South Korea

Location

Seoul Samsung Medical Clinic

Seoul, 122-823, South Korea

Location

Dr. Lee's Clinic of Internal Medicine

Seoul, 139-716, South Korea

Location

Sung's Medical Clinic

Seoul, 153-806, South Korea

Location

GF Internal Medicine

Seoul, South Korea

Location

Jong Koo Lee Heart Clinic

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, 682-714, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

001-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: April 17, 2013
• Study Start: December 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 18, 2017
• Results First Posted: April 18, 2017

Record last verified: 2017-03

Locations

KR (27)