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Prevenar13 Post Market Surveillance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01509105
First Posted: January 12, 2012
Last Update Posted: February 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
September 30, 2011
January 12, 2012
December 20, 2016
February 13, 2017
February 13, 2017
September 2011
January 2016   (Final data collection date for primary outcome measure)
  • 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.
Frequency of any adverse event after immunization with Prevenar13 at a routine clinical setting [ Time Frame: 7days ]
Complete list of historical versions of study NCT01509105 on ClinicalTrials.gov Archive Site
  • 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.
  • Duration, severity of the adverse event [ Time Frame: 7days ]
  • Clinical outcome after the adverse event [ Time Frame: 7days ]
  • Discontinuation due to the adverse event [ Time Frame: 7days ]
Not Provided
Not Provided
 
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.
non-randomization, non-probability sampling
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
All infants and children meeting the usual prescribing criteria for Prevenar 13 as per the local product information for usage
Healthy
Biological: 13-valent pneumococcal vaccine
0.5mL IM (Intramuscular administration) as per recommended schedule
Other Name: Prevenar 13
Group1
Intervention: Biological: 13-valent pneumococcal vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
649
January 2016
January 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
6 Weeks to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01509105
6096A1-4029
B1851057 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2016