Post Marketing Surveillance To Observe Safety Of Prevenar 13
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Pfizer
- Enrollment
- 649
- Locations
- 18
- Primary Endpoint
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
non-randomization, non-probability sampling
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
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 Outcomes
- Duration of Adverse Events (AEs)(Baseline up to 28 days after last dose of study vaccination (13 Months))
- Number of Participants With Adverse Events (AEs) by Severity(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)(Baseline up to 28 days after last dose of study vaccination (13 Months))
- Number of Participants Discontinued Due to Adverse Events(Baseline up to 28 days after last dose of study vaccination (13 Months))