Prevenar (PCV-7) Post-Licensure Safety Study In Russia
26 de julio de 2012 actualizado por: Pfizer
Prevenar Post-Licensure Safety Study in Russia: Frequency Of Fever Post Vaccination
This study is planned to monitor the local and/or systemic reactions and compatibility of PCV-7 with routine vaccines in the Russian National immunization schedule. Consistent with the observational nature of this protocol, Prevenar will be administered as standard of care.
The aim of this study is to estimate the incidence of febrile reactions more than 38.0 degrees Celsius, specifically (≥38 to < 39 degrees C; > 39 to < 40 degrees C and > 40 degrees C, and the frequency of other local or systemic reactions following vaccination with Prevenar (PCV-7) co-administered with other routine childhood vaccines under the conditions of routine daily use in the Russian Federation.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Actual)
100
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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Moscow, Federación Rusa, 119049
- Russian State Medical University
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Moscow, Federación Rusa, 119296
- Russian Academy of Medical Sciences
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Saint Petersburg, Federación Rusa, 197022
- Research Institute of Childhood Infections
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Yekaterinburg, Federación Rusa, 620085
- City Children's Clinical Hospital #8
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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
3 meses a 1 año (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Infants and Children from 3 months to 23 months at enrollment
Descripción
Inclusion Criteria:
- Infants eligible for Prevenar vaccination according to the Regulatory approved terms of the marketing authorization in the Russian Federation:
- Infants from 3 months up to 23 months of age who may benefit from active immunization against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media).
- Parents or legal guardians willing and able to complete the diary cards.
Exclusion Criteria:
- Hypersensitivity to the active substances or to any of the excipients;
- Hypersensitivity to diphtheria toxoid;
- Age less than 3 months or greater than or equal to 2 years at enrollment;
- Contraindications as listed in the Package Insert / Russian SmPC for either Prevenar or for any concomitantly used other vaccines;
- Previously vaccinated with 23-valent pneumococcal polysaccharide vaccine;
- Prophylactic use of non-steroidal anti-inflammatory medications and/or acetaminophen (e.g., paracetamol). However, acetaminophen/paracetamol may be administered for treatment of fever, pain, etc.
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
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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healthy children after vaccination
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Non-interventional observational study
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants With Febrile Reactions Post-dose 1
Periodo de tiempo: Day 1 to Day 3 post-dose 1
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Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children.
Fever was defined as a temperature of greater than or equal to (>=) 38 degrees Celsius (C).
Percentage of participants with febrile reaction of >=38 degrees C to less than or equal to (<=) 39 degrees C, >39 degrees C to <=40 degrees C and >40 degrees C were observed.
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Day 1 to Day 3 post-dose 1
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Percentage of Participants With Febrile Reactions Post-dose 2
Periodo de tiempo: Day 1 to Day 3 post-dose 2
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Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children.
Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.
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Day 1 to Day 3 post-dose 2
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Percentage of Participants With Febrile Reactions Post-dose 3
Periodo de tiempo: Day 1 to Day 3 post-dose 3
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Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children.
Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.
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Day 1 to Day 3 post-dose 3
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Percentage of Participants With Febrile Reactions Post-dose 4
Periodo de tiempo: Day 1 to Day 3 post-dose 4
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Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children.
Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C was observed.
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Day 1 to Day 3 post-dose 4
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants With Pre-Specified Local Reactions Post-dose 1
Periodo de tiempo: Day 1 to Day 3 post-dose 1
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Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 centimeters [cm]); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm).
Participants may be represented in more than 1 category.
Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
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Day 1 to Day 3 post-dose 1
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Percentage of Participants With Pre-Specified Local Reactions Post-dose 2
Periodo de tiempo: Day 1 to Day 3 post-dose 2
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm).
Participants may be represented in more than 1 category.
Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
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Day 1 to Day 3 post-dose 2
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Percentage of Participants With Pre-Specified Local Reactions Post-dose 3
Periodo de tiempo: Day 1 to Day 3 post-dose 3
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm).
Participants may be represented in more than 1 category.
Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
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Day 1 to Day 3 post-dose 3
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Percentage of Participants With Pre-Specified Local Reactions Post-dose 4
Periodo de tiempo: Day 1 to Day 3 post-dose 4
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Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm).
Participants may be represented in more than 1 category.
Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
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Day 1 to Day 3 post-dose 4
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Percentage of Participants With Pre-Specified Systemic Events Post-dose 1
Periodo de tiempo: Day 1 to Day 3 post-dose 1
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Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Day 1 to Day 3 post-dose 1
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Percentage of Participants With Pre-Specified Systemic Events Post-dose 2
Periodo de tiempo: Day 1 to Day 3 post-dose 2
|
Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Day 1 to Day 3 post-dose 2
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Percentage of Participants With Pre-Specified Systemic Events Post-dose 3
Periodo de tiempo: Day 1 to Day 3 post-dose 3
|
Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Day 1 to Day 3 post-dose 3
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Percentage of Participants With Pre-Specified Systemic Events Post-dose 4
Periodo de tiempo: Day 1 to Day 3 post-dose 4
|
Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Day 1 to Day 3 post-dose 4
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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 diciembre de 2009
Finalización primaria (Actual)
1 de agosto de 2011
Finalización del estudio (Actual)
1 de agosto de 2011
Fechas de registro del estudio
Enviado por primera vez
21 de septiembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
21 de septiembre de 2010
Publicado por primera vez (Estimar)
23 de septiembre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
31 de agosto de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
26 de julio de 2012
Última verificación
1 de julio de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 0887X1-4596
- B1841011
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. .