Pneumococcal DiseaseNCT01834222
Post Market Surveillance to Observe Safety of Prevenar13™ in Adults
An observational study of Pneumococcal Disease, run by Pfizer at 27 sites in South Korea.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumococcal Disease
- What is being tested?
- Non-intervention
- How many people
- 659 participants
- Where
- 27 sitesSouth Korea
- Study dates
- Dec 2013to Mar 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Korean adults aged 18 years and older who receive Prevenar13™ in a routine clinical setting
Who may be able to join
- 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.
Who cannot join
- Subjects who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
South Korea27 sites
Hansarang Internal Medicine Hospital
Busan, South Korea, 616-820
Pusan National University Hospital
Busan, 49241
Pusan National University Hospital
Busan, 602-739
Keimyung University Dongsan Hospital
Daegu, 41931
Samsung Happy Clinic
Daejeon, 300-826
Chungnam National University Hospital
Daejeon, 301-721
Pusan National Univeristy Hospital
Daejeon, 301-812
MiSo Medical
Daejeon, 302-120
Sun's internal medicine
Daejeon, 305-509
Techno Internal Medicine Clinic
Daejeon, 305-509
Chuncheon Sacred Heart Hospital-Hallym University
Gangwon-do, 24253
Lee soo yang Internal Medical Clinic
Guro-gu, Seoul, 152-893
Dr. Lee's Medical Clinic
Gwangju, 501-190
Chonnam National University Hospital
Gwangju, 501-757
Chonnam National University Hospital
Gwangju, 61469
Suh Jeong Min Clinic
Gyeonggi-do, 441-885
Bundang 21st Clinic
Gyeonggi-do, 463-823
Light & Salt Internal Medicine
Gyeonggi-do
Chungnam National University Hospital (CNUH)
Jung-gu, Daejeon, 35015
Bundang 21st Clinic
Seongnam-si, Gyeonggi-do, 463-823
Shin Clinic Internal Medicine
Seoul, South Korea, 135-830
Seoul Samsung Medical Clinic
Seoul, 122-823
Dr. Lee's Clinic of Internal Medicine
Seoul, 139-716
Sung's Medical Clinic
Seoul, 153-806
GF Internal Medicine
Seoul
Jong Koo Lee Heart Clinic
Seoul
Ulsan University Hospital
Ulsan, 682-714
About this study
Official title: 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).
Read the detailed description
non-randomization, non-probability sampling
- Conditions
- Pneumococcal Disease
- Being tested
- Non-intervention
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionBiological
Non-intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Korean adults aged 50 years and older who receive Prevenar13™ in a routine clinical setting Receives: Biological: Non-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1) up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pneumococcal DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834222
- Sponsor's protocol ID
- B1851143
- Status last verified
- Mar 2017
- First submitted
- 12 Apr 2013
- Last updated
- 18 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance To Observe Safety Of Prevenar 13 In Adults
- ClinicalTrials.gov ID
- NCT01834222
- Acronym / sponsor ID
- B1851143
- Conditions
- Pneumococcal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 659 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Posted 18 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Biological: Non-interventionKorean adults aged 50 years and older who receive Prevenar13™ in a routine clinical setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Korean adults aged 18 years and older who receive Prevenar13™ in a routine clinical setting
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionNon-intervention | Biological | 1 |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Disease, run by Pfizer at 27 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline (Day 1) up to Day 29). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.