Prevenar13 Post Market Surveillance

Post Marketing Surveillance To Observe Safety Of Prevenar 13

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: 13-valent pneumococcal vaccine

Detailed Description

non-randomization, non-probability sampling

• Study Type: Observational
• Enrollment (Actual): 649

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group1	Biological: 13-valent pneumococcal vaccine; 0.5mL IM (Intramuscular administration) as per recommended schedule; Other Names: Prevenar 13

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): 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.	Within 7 days after Vaccination 1
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): 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.	Within 7 days after Vaccination 2
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): 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.	Within 7 days after Vaccination 3
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): 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.	Within 28 days after Vaccination 4
Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): 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.	Within 7 days after Vaccination 1
Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): 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.	Within 7 days after Vaccination 2
Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): 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.	Within 7 days after Vaccination 3
Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): 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.	Within 28 days after Vaccination 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 AE is the total time from onset of adverse event till the event is resolved in participants who had at least 1 AE.	Baseline up to 28 days after last dose of study vaccination (13 Months)
Number of Participants With 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. 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).	Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4
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 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'.	Baseline up to 28 days after last dose of study vaccination (13 Months)
Number of Participants Discontinued Due to Adverse Events	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.	Baseline up to 28 days after last dose of study vaccination (13 Months)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: September 30, 2011
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (Estimate): January 12, 2012

Study Record Updates

• Last Update Posted (Actual): February 13, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 6096A1-4029; B1851057 (Other Identifier: Alias Study Number)