- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01030562
Immunogenicity of Off-Schedule Dosing of HPV Vaccine
Immunogenicity of the HPV-6, 11, 16, 18 Vaccine Among Adolescent Girls Who Receive Vaccine Doses at Non-recommended Intervals and Factors Related to Non-adherence
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Georgia
-
Tucker, Georgia, Estados Unidos, 30084-7047
- Kaiser Permanente Crescent Medical Center - Pediatrics/Adolescent Medicine
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21201-1509
- University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
-
-
Missouri
-
Kansas City, Missouri, Estados Unidos, 64108-4619
- Children's Mercy Hospital and Clinics - Infectious Diseases
-
-
Ohio
-
Cincinnati, Ohio, Estados Unidos, 45229-3039
- Cincinnati Children?s Hospital Medical Center - Adolescent Medicine
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Estados Unidos, 15241-3100
- Primary Physicians Research Inc. - Pittsburgh
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37232-0001
- Monroe Carell Jr. Children's Hospital at Vanderbilt - Adolescent Medicine
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98101-1466
- Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
Girls will be eligible if they are: -9 to 17 years of age (defined as between 9 years 0 days and younger than 18 years of age) at time of receipt of third HPV dose; -Receiving the third human papillomavirus (HPV) vaccine as part of routine health care; -Able and willing to complete all study visits and evaluations; -Able and willing to participate in the study by providing written informed assent/consent (as applicable); -Parent or legal guardian provides permission (as applicable). Parent/legal guardian inclusion criteria: At sites administering the survey and health literacy assessment, parent or legal guardian providing permission for their daughter to participate in the study will be eligible to participate in the parental questionnaire if they are able to provide informed consent for themselves.
Exclusion Criteria:
Girls meeting any of the following exclusion criteria at baseline will be excluded from study participation. -Unable to comply with the study protocol. -Receipt of more than 3 doses of human papillomavirus (HPV) vaccine. -Receipt of blood and or blood products (including immunoglobulin) in the past 3 months or anticipated receipt during the study period. -History of any physical, mental, or developmental disorder that study personnel believe may hinder a participant's ability to comply with the study requirements. -History of malignancy or confirmed or suspected immunodeficient condition, such as human immunodeficiency virus infection. -Receipt of or history of receipt of any medications or treatments that affect the immune system, such as immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity since six months prior to the first HPV vaccine dose. -Receipt of long-term (greater than or equal to 2 weeks) potentially immunosuppressive corticosteroid use within six months or anticipated receipt during the study period. Specifically, potentially immunosuppressive corticosteroids or any parenteral corticosteroid, high dose (>800 mcg/day) beclomethasone dipropionate or equivalent medication; nasal and topical steroids are allowed. -Current or former participation in HPV vaccine related research. -Receipt of an investigational or alternate (Cervarix) HPV vaccine. -Receipt of a live virus vaccine (varicella virus vaccine, any measles, mumps, or rubella virus vaccine, or yellow fever vaccine but not including live attenuated influenza virus vaccine) within 4 weeks before or after the 3rd dose of HPV vaccine or anticipated receipt of a live virus vaccine within 4 weeks after the 3rd dose of HPV vaccine. However, subjects may receive any vaccine on the same day as the third dose of HPV. Parent/legal guardian exclusion criteria: If the site is actively recruiting adolescents from a clinic population, the survey and health literacy assessments are not available for the parents/legal guardians from that clinic population. Therefore they will not be asked to participate in the study. -At sites administering the survey and health literacy assessment, parents/legal guardians meeting any of the following exclusion criteria at baseline will be excluded from filling out the study questionnaire examining factors associated with adherence: -History of any physical, mental or developmental disorder that study personnel believe may hinder a participant's ability to comply with study requirements.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
---|
Alternate Arm
Subjects who meet eligibility requirements but do not fit into any of the primary experimental arms.
|
Control Arm
Subjects with an on-time interval between Dose 1 and 2 and an on-time interval between Dose 2 and 3.
|
Experimental/Primary Arm 1
This primary arm will consist of subjects receiving the second dose on time/third dose substantially late.
|
Experimental/Primary Arm 2
This primary arm will consist of subjects receiving the second dose substantially late/third dose on time.
|
Experimental/Primary Arm 3
This primary arm will consist of subjects receiving the second dose substantially late/third dose substantially late.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Geometric mean titer (GMT) to vaccine human papillomavirus (HPV) serotypes as measured by HPV4-plex IgG ELISA.
Periodo de tiempo: One month after the third HPV vaccine dose.
|
One month after the third HPV vaccine dose.
|
Sero-response rate (proportion of subjects developing antibody to vaccine HPV serotypes).
Periodo de tiempo: One month after the third HPV vaccine dose.
|
One month after the third HPV vaccine dose.
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
GMT to vaccine HPV serotypes as measured by HPV4-plex IgG ELISA
Periodo de tiempo: Prior to the third HPV vaccine dose and six months after the third HPV vaccine dose.
|
Prior to the third HPV vaccine dose and six months after the third HPV vaccine dose.
|
Sero-response rate (proportion of subjects developing antibody to vaccine HPV serotypes).
Periodo de tiempo: Prior to the third HPV vaccine dose and six months after the third HPV vaccine dose.
|
Prior to the third HPV vaccine dose and six months after the third HPV vaccine dose.
|
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 08-0012
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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. .
Ensayos clínicos sobre Infección viral del papiloma
-
University of Wisconsin, MadisonTerminadoInfección viral respiratoriaEstados Unidos
-
Sinovac Biotech Co., LtdRetiradoInfección, Viral, EnterovirusPorcelana
-
Sinovac Biotech Co., LtdTerminadoInfección, Viral, EnterovirusPorcelana
-
Hospices Civils de LyonReclutamiento
-
National Institute of Allergy and Infectious Diseases...TerminadoInfección viral del Nilo OccidentalEstados Unidos
-
ShireTerminadoConjuntivitis viral agudaEstados Unidos, Brasil
-
Materia Medica HoldingTerminadoInfección viral respiratoria agudaFederación Rusa
-
Children's Hospital Medical Center, CincinnatiHoxworth Blood CenterReclutamientoTrasplante alogénico de células madre | Infección viral | Reactivación viralEstados Unidos
-
University Health Network, TorontoTerminadoInfección viral de la hepatitis CCanadá
-
Nanjing Zenshine PharmaceuticalsAún no reclutando