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Prevenar13 Post Market Surveillance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01509105
First received: September 30, 2011
Last updated: December 20, 2016
Last verified: December 2016
  Purpose
It is an observational multi-center study to assess the safety profile of Prevenar13 used among Korean children in the routine clinical setting following a licensure and introduction of the vaccine. This study is designed to fulfill regulatory requirement for any new drug authorized by KFDA.

Condition Intervention
Healthy
Biological: 13-valent pneumococcal vaccine

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post Marketing Surveillance To Observe Safety Of Prevenar 13

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1 [ Time Frame: Within 7 days after Vaccination 1 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

  • Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2 [ Time Frame: Within 7 days after Vaccination 2 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

  • Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3 [ Time Frame: Within 7 days after Vaccination 3 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

  • Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4 [ Time Frame: Within 28 days after Vaccination 4 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

  • Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1 [ Time Frame: Within 7 days after Vaccination 1 ]
    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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.

  • Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2 [ Time Frame: Within 7 days after Vaccination 2 ]
    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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.

  • Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3 [ Time Frame: Within 7 days after Vaccination 3 ]
    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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.

  • Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4 [ Time Frame: Within 28 days after Vaccination 4 ]
    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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.


Secondary Outcome Measures:
  • Duration of Adverse Events (AEs) [ Time Frame: Baseline up to 28 days after last dose of study vaccination (13 Months) ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time from onset of adverse event till the event is resolved in participants who had at least 1 AE.

  • Number of Participants With Adverse Events (AEs) by Severity [ Time Frame: Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).

  • Number of Participants With Outcome in Response to Adverse Events (AEs) [ Time Frame: Baseline up to 28 days after last dose of study vaccination (13 Months) ]
    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 response to a question answered by those participants who had at least 1 AE: 'Is the adverse event still present?' as 'yes', 'unknown' or 'no-resolved'.

  • Number of Participants Discontinued Due to Adverse Events [ Time Frame: Baseline up to 28 days after last dose of study vaccination (13 Months) ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.


Enrollment: 649
Study Start Date: September 2011
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group1 Biological: 13-valent pneumococcal vaccine
0.5mL IM (Intramuscular administration) as per recommended schedule
Other Name: Prevenar 13

Detailed Description:
non-randomization, non-probability sampling
  Eligibility

Ages Eligible for Study:   6 Weeks to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All infants and children meeting the usual prescribing criteria for Prevenar 13 as per the local product information for usage
Criteria

Inclusion Criteria:

  • Infants and children aged 6 weeks to 5 years, whose legally authorized representatives of patients agree to provide written informed consent form (data privacy statement).

Exclusion Criteria:

  • Infants and children who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509105

Locations
Korea, Republic of
Choi's Pediatric Clinic
Wonju-si, Gangwon-do, Korea, Republic of, 220-956
Seoul Children's Hospital
Osan, Gyeonggi-do, Korea, Republic of, 447-804
Bundang Pediatric Clinic
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-821
Teun Teun Pediatric clinic
Suwon-si, Gyeonggi-do, Korea, Republic of, 443-471
Namujungwon Women's Hospital
Yangju, Gyeonggi-do, Korea, Republic of, 482-050
Yonsei Pediatric Clinic
Yongin-si, Gyeonggi-do, Korea, Republic of, 448-508
Busan National University Hospital
Busan, Korea, Republic of, 602-739
Jaeil Alliance Pediatrics Clinic
Daegu, Korea, Republic of, 701847
Teun Teun Pediatric Clinic
Daegu, Korea, Republic of, 702886
Eulji University Hospital
Daejeon, Korea, Republic of, 302-799
Korea University Ansan Hospital
Gyeonggi-do, Korea, Republic of, 425-707
Cha Bundang Medical Center, Cha University
Gyeonggi-do, Korea, Republic of, 463-712
Inha University Hospital
Incheon, Korea, Republic of, 400-711
Lee Ha Young Pediatrics
Incheon, Korea, Republic of, 402-852
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Eulji Medical Center
Seoul, Korea, Republic of, 139-711
JaMo Women's Hospital
Suyeong-gu, Korea, Republic of, 613-806
Ulsan University Hospital
Ulsan, Korea, Republic of, 682-714
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01509105     History of Changes
Other Study ID Numbers: 6096A1-4029  B1851057 
Study First Received: September 30, 2011
Results First Received: December 20, 2016
Last Updated: December 20, 2016

Additional relevant MeSH terms:
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 28, 2017