Prevenar13 Post Market Surveillance
20 de diciembre de 2016 actualizado por: Pfizer
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
non-randomization, non-probability sampling
Tipo de estudio
De observación
Inscripción (Actual)
649
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
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Busan, Corea, república de, 602-739
- Busan National University Hospital
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Daegu, Corea, república de, 701847
- Jaeil Alliance Pediatrics Clinic
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Daegu, Corea, república de, 702886
- Teun Teun Pediatric Clinic
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Daejeon, Corea, república de, 302-799
- Eulji University Hospital
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Gyeonggi-do, Corea, república de, 425-707
- Korea University Ansan Hospital
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Gyeonggi-do, Corea, república de, 463-712
- CHA Bundang Medical Center, CHA University
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Incheon, Corea, república de, 400-711
- Inha University Hospital
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Incheon, Corea, república de, 402-852
- Lee Ha Young Pediatrics
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Seoul, Corea, república de, 138-736
- Asan Medical Center
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Seoul, Corea, república de, 139-711
- Eulji Medical Center
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Suyeong-gu, Corea, república de, 613-806
- JaMo Women's Hospital
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Ulsan, Corea, república de, 682-714
- Ulsan University Hospital
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Gangwon-do
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Wonju-si, Gangwon-do, Corea, república de, 220-956
- Choi's Pediatric Clinic
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Gyeonggi-do
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Osan, Gyeonggi-do, Corea, república de, 447-804
- Seoul Children's Hospital
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Seongnam-si, Gyeonggi-do, Corea, república de, 463-821
- Bundang Pediatric Clinic
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Suwon-si, Gyeonggi-do, Corea, república de, 443-471
- Teun Teun Pediatric Clinic
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Yangju, Gyeonggi-do, Corea, república de, 482-050
- Namujungwon Women's Hospital
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Yongin-si, Gyeonggi-do, Corea, república de, 448-508
- Yonsei Pediatric Clinic
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
1 mes a 17 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
All infants and children meeting the usual prescribing criteria for Prevenar 13 as per the local product information for usage
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Solo caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Grupo 1
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0.5mL IM (Intramuscular administration) as per recommended schedule
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1
Periodo de tiempo: 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.
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Within 7 days after Vaccination 1
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|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2
Periodo de tiempo: 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.
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Within 7 days after Vaccination 2
|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3
Periodo de tiempo: 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
|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4
Periodo de tiempo: Within 28 days after Vaccination 4
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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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Within 28 days after Vaccination 4
|
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Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1
Periodo de tiempo: 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.
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Within 7 days after Vaccination 1
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Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2
Periodo de tiempo: 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.
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Within 7 days after Vaccination 2
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Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3
Periodo de tiempo: Within 7 days after Vaccination 3
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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.
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Within 7 days after Vaccination 3
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Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4
Periodo de tiempo: 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.
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Within 28 days after Vaccination 4
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Duration of Adverse Events (AEs)
Periodo de tiempo: Baseline up to 28 days after last dose of study vaccination (13 Months)
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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.
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Baseline up to 28 days after last dose of study vaccination (13 Months)
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Number of Participants With Adverse Events (AEs) by Severity
Periodo de tiempo: Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4
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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).
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Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4
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Number of Participants With Outcome in Response to Adverse Events (AEs)
Periodo de tiempo: Baseline up to 28 days after last dose of study vaccination (13 Months)
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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'.
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Baseline up to 28 days after last dose of study vaccination (13 Months)
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Number of Participants Discontinued Due to Adverse Events
Periodo de tiempo: Baseline up to 28 days after last dose of study vaccination (13 Months)
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
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Baseline up to 28 days after last dose of study vaccination (13 Months)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2011
Finalización primaria (Actual)
1 de enero de 2016
Finalización del estudio (Actual)
1 de enero de 2016
Fechas de registro del estudio
Enviado por primera vez
30 de septiembre de 2011
Primero enviado que cumplió con los criterios de control de calidad
9 de enero de 2012
Publicado por primera vez (Estimar)
12 de enero de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de febrero de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
20 de diciembre de 2016
Última verificación
1 de diciembre de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 6096A1-4029
- B1851057 (Otro identificador: Alias Study Number)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .