ID

34736

Descripción

Study ID: 104951 Clinical Study ID: 104951 Study Title: A Phase III, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 0_ 1_ 6 month schedule in healthy female subjects aged 10 - 14 years. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290277 https://clinicaltrials.gov/ct2/show/NCT00290277 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: HPV-16/18 L1/AS04 Vaccine Trade Name: N/A Study Indication: Infections, Papillomavirus This form contains information about informed consent and demographics and should be filled in at visit 1 (month 0, pre-vacc).

Link

https://clinicaltrials.gov/ct2/show/NCT00290277

Palabras clave

Versiones (1)
  1. 25/1/19 25/1/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

25 de enero de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Evaluation of immunogenicity and safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine in healthy females NCT00290277

Inglés

Demography

1 formularios  
  1. StudyEvent: ODM
    1. Demography
Informed consent
Descripción

Informed consent

Alias
UMLS CUI-1
C0021430
Informed consent Date
Descripción

I certify, that Informed Consent has been obtained prior to any study procedure.

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0184661
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0011008
Administrative data
Descripción

Administrative data

Alias
UMLS CUI-1
C1320722
Centre number
Descripción

Centre number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Subject number
Descripción

Subject number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Treatment number
Descripción

Treatment number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1522541
UMLS CUI [1,2]
C0600091
Protocol number
Descripción

Protocol number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008971
UMLS CUI [1,2]
C0600091
Date of visit
Descripción

Date of visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Demography
Descripción

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Descripción

Date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Sex
Descripción

In this study, only female participants were allowed.

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
Ethnicity, tick one:
Descripción

Ethnicity

Tipo de datos

integer

Alias
UMLS CUI [1]
C0015031
Race: African American / African Heritage
Descripción

Race: African American / African Heritage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027567
UMLS CUI [2,1]
C0085756
UMLS CUI [2,2]
C0034510
Race: American Indian or Alaskan Native
Descripción

Race: American Indian or Alaskan Native

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515945
UMLS CUI [1,2]
C0034510
Race: Asian - Central/South Asian Heritage
Descripción

Race: Asian - Central/South Asian Heritage

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0238696
UMLS CUI [1,2]
C0034510
UMLS CUI [2,1]
C1519427
UMLS CUI [2,2]
C0034510
Race: Asian - East Asian Heritage
Descripción

Race: Asian - East Asian Heritage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4540996
Race: Asian - Japanese Heritage
Descripción

Race: Asian - Japanese Heritage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1556094
Race: Asian - South East Asian Heritage
Descripción

Race: Asian - South East Asian Heritage

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0238697
UMLS CUI [1,2]
C0034510
Race: Native Hawaiian or Other Pacific Islander
Descripción

Race: Native Hawaiian or Other Pacific Islander

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513907
Race: White - Arabic/North African Heritage
Descripción

Race: White - Arabic/North African Heritage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0238604
UMLS CUI [2,1]
C2698217
UMLS CUI [2,2]
C0034510
Race: White - White/Caucasian/European Heritage
Descripción

Race: White - White/Caucasian/European Heritage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0043157
Other Race, specify
Descripción

Other Race, specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C3845569
Volver a la parte superior de la página

Similar models

Demography

1 formularios
  1. StudyEvent: ODM
    1. Demography
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Informed consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
Informed consent Date
date
C0021430 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Centre number
Item
Centre number
text
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Treatment number
Item
Treatment number
text
C1522541 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Protocol number
Item
Protocol number
text
C0008971 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity, tick one:
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity, tick one:
CL Item
American Hispanic or Latino (1)
CL Item
Not American Hispanic or Latino (2)
Race: African American / African Heritage
Item
Race: African American / African Heritage
boolean
C0027567 (UMLS CUI [1])
C0085756 (UMLS CUI [2,1])
C0034510 (UMLS CUI [2,2])
Race: American Indian or Alaskan Native
Item
Race: American Indian or Alaskan Native
boolean
C1515945 (UMLS CUI [1,1])
C0034510 (UMLS CUI [1,2])
Race: Asian - Central/South Asian Heritage
Item
Race: Asian - Central/South Asian Heritage
boolean
C0238696 (UMLS CUI [1,1])
C0034510 (UMLS CUI [1,2])
C1519427 (UMLS CUI [2,1])
C0034510 (UMLS CUI [2,2])
Race: Asian - East Asian Heritage
Item
Race: Asian - East Asian Heritage
boolean
C4540996 (UMLS CUI [1])
Race: Asian - Japanese Heritage
Item
Race: Asian - Japanese Heritage
boolean
C1556094 (UMLS CUI [1])
Race: Asian - South East Asian Heritage
Item
Race: Asian - South East Asian Heritage
boolean
C0238697 (UMLS CUI [1,1])
C0034510 (UMLS CUI [1,2])
Race: Native Hawaiian or Other Pacific Islander
Item
Race: Native Hawaiian or Other Pacific Islander
boolean
C1513907 (UMLS CUI [1])
Race: White - Arabic/North African Heritage
Item
Race: White - Arabic/North African Heritage
boolean
C0238604 (UMLS CUI [1])
C2698217 (UMLS CUI [2,1])
C0034510 (UMLS CUI [2,2])
Race: White - White/Caucasian/European Heritage
Item
Race: White - White/Caucasian/European Heritage
boolean
C0043157 (UMLS CUI [1])
Other Race, specify
Item
Other Race, specify
text
C0034510 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial