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
Study Type
OBSERVATIONAL
Enrollment
649
0.5mL IM (Intramuscular administration) as per recommended schedule
Choi's Pediatric Clinic
Wŏnju, Gangwon-do, South Korea
Seoul Children's Hospital
Osan, Gyeonggi-do, South Korea
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.
Time frame: 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.
Time frame: 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.
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Bundang Pediatric Clinic
Seongnam-si, Gyeonggi-do, South Korea
Teun Teun Pediatric clinic
Suwon, Gyeonggi-do, South Korea
Namujungwon Women's Hospital
Yangju, Gyeonggi-do, South Korea
Yonsei Pediatric Clinic
Yongin-si, Gyeonggi-do, South Korea
Busan National University Hospital
Busan, South Korea
Jaeil Alliance Pediatrics Clinic
Daegu, South Korea
Teun Teun Pediatric Clinic
Daegu, South Korea
Eulji University Hospital
Daejeon, South Korea
...and 8 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within 28 days after Vaccination 4
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.
Time frame: 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).
Time frame: 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'.
Time frame: 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.
Time frame: Baseline up to 28 days after last dose of study vaccination (13 Months)