13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.
27 de febrero de 2015 actualizado por: Pfizer
A Phase 3, Randomized, Open-label Trial To Evaluate The Safety, Tolerability And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials Given With Routine Pediatric Vaccinations In Healthy Infants
This study will compare the immune responses of the infants who have been given 13vPnC in the mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in the single-dose syringe formulation.
It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all infants who are vaccinated.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
500
Fase
- Fase 3
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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The Gambia
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Ksmd, The Gambia, Gambia
- Fajikunda Major Health Centre
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The Gambia, West Africa
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Fajara, The Gambia, West Africa, Gambia, 000273
- Medical Research Council Unit, The Gambia
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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 2 meses (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Aged 42 to 70 days at enrollment.
- Determined by medical history, physical examination, and clinical judgment to be eligible for the study
- Weight of 3.5 kg or greater at the time of enrollment
Exclusion Criteria:
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with pneumococcal conjugate vaccine.
- Receipt of blood products or gamma-globulin since birth
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
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Multidose Vial Group
Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the multidose vial formulation.
Each dose is 0.5 mL
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Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg.
Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg.
Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
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Comparador activo: Single-Dose Syringe Group
Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the single-dose syringe formulation.
Each dose is 0.5 mL
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Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg.
Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg.
Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
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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 Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Periodo de tiempo: 1 month after the infant series
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Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented.
Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants.
Here "n"= participants with valid and determinate IgG concentration to the given serotype.
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1 month after the infant series
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Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Periodo de tiempo: 1 month after the infant series
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Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented.
GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated.
Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Here "n"= participants with valid and determinate IgG concentration to the given serotype.
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1 month after the infant series
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Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Periodo de tiempo: Within 5 days after Dose 1(Day 2 to Day 6) of the infant series
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Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary.
Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement).
Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm).
Participants may be represented in more than 1 category.
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Within 5 days after Dose 1(Day 2 to Day 6) of the infant series
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Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Periodo de tiempo: Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series
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Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary.
Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement).
Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm).
Participants may be represented in more than 1 category.
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Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series
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Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Periodo de tiempo: Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series
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Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary.
Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement).
Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm).
Participants may be represented in more than 1 category.
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Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series
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Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Periodo de tiempo: Within 5 days after Dose 1 (Day 2 to Day 6) of infant series
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Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed).
Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted).
Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 5 days after Dose 1 (Day 2 to Day 6) of infant series
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Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Periodo de tiempo: Within 5 days after Dose 2 (Day 2 to Day 6) of infant series
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Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed).
Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted).
Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 5 days after Dose 2 (Day 2 to Day 6) of infant series
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Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Periodo de tiempo: Within 5 days after Dose 3 (Day 2 to Day 6) of infant series
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Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed).
Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted).
Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 5 days after Dose 3 (Day 2 to Day 6) of infant series
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series
Periodo de tiempo: Dose 1 up to 28 to 42 days after dose 3
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An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship.
An 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.
Treatment-emergent are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state
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Dose 1 up to 28 to 42 days after dose 3
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1
Periodo de tiempo: Informed consent up to Dose 1
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An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship.
An 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.
Adverse events were also reported in participants who provided consent but were not randomized in this study.
The data of these participants has been reported under 'Screened Only' arm.
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Informed consent up to Dose 1
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Periodo de tiempo: 1 month after the infant series
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Percentage of participants achieving OPA Titer >= lower limit of quantitation (LLOQ) along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented.
The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13.
Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants.
Here "n"= Number of participants with an antibody titer ≥ LLOQ for the given serotype.
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1 month after the infant series
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Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Periodo de tiempo: 1 month after the infant series
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Antibody geometric mean titers as measured by OPA assay for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented.
GMTs were calculated using all participants with available data for the specified blood draw.
CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers.
Here "n"= participants evaluable =specified category.
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1 month after the infant series
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
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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 enero de 2014
Finalización primaria (Actual)
1 de septiembre de 2014
Finalización del estudio (Actual)
1 de septiembre de 2014
Fechas de registro del estudio
Enviado por primera vez
9 de septiembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
14 de octubre de 2013
Publicado por primera vez (Estimar)
17 de octubre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
13 de marzo de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
27 de febrero de 2015
Última verificación
1 de febrero de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B4671001
- 2012-000482-21 (Número EudraCT)
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. .