Prevenar13 Post Market Surveillance
- Conditions
- Healthy
- Interventions
- Biological: 13-valent pneumococcal vaccine
- Registration Number
- NCT01509105
- Lead Sponsor
- Pfizer
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 649
- 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).
- Infants and children who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group1 13-valent pneumococcal vaccine -
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1 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 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 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 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 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 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 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 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
Name Time Method Duration of Adverse Events (AEs) 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 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) 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 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.
Trial Locations
- Locations (18)
Choi's Pediatric Clinic
🇰🇷Wonju-si, Gangwon-do, Korea, Republic of
Seoul Children's Hospital
🇰🇷Osan, Gyeonggi-do, Korea, Republic of
Teun Teun Pediatric clinic
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Bundang Pediatric Clinic
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Namujungwon Women's Hospital
🇰🇷Yangju, Gyeonggi-do, Korea, Republic of
Yonsei Pediatric Clinic
🇰🇷Yongin-si, Gyeonggi-do, Korea, Republic of
Jaeil Alliance Pediatrics Clinic
🇰🇷Daegu, Korea, Republic of
Busan National University Hospital
🇰🇷Busan, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Teun Teun Pediatric Clinic
🇰🇷Daegu, Korea, Republic of
Eulji University Hospital
🇰🇷Daejeon, Korea, Republic of
Cha Bundang Medical Center, Cha University
🇰🇷Gyeonggi-do, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Lee Ha Young Pediatrics
🇰🇷Incheon, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Eulji Medical Center
🇰🇷Seoul, Korea, Republic of
JaMo Women's Hospital
🇰🇷Suyeong-gu, Korea, Republic of