ID

34856

Descripción

Study ID: 107022 Clinical Study ID: 107022 Study Title: A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00321373 Study Link: https://clinicaltrials.gov/ct2/show/NCT00321373 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Trade Name: FluarixTM Study Indication: Influenza The purpose of his form is to document if informed consent has been obtained and to collect the subject's demographic data. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1

Link

https://clinicaltrials.gov/ct2/show/NCT00321373

Palabras clave

Versiones (2)
  1. 29/1/19 29/1/19 -
  2. 1/2/19 1/2/19 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

1 de febrero 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.

Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373

Inglés

Informed Consent and Demographics

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of Visit
Descripción

Date of Visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Descripción

Subject Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
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]
C0021430
Can blood samples be used for further research into FLU-LD vaccines or infection?
Descripción

Blood Sample Usage for Further Research

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008972
UMLS CUI [2,1]
C0021403
UMLS CUI [2,2]
C0008972
UMLS CUI [3,1]
C0021400
UMLS CUI [3,2]
C0008972
Demographics
Descripción

Demographics

Alias
UMLS CUI-1
C1704791
Center Number
Descripción

Center Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of Birth
Descripción

Date of Birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Gender
Descripción

Gender

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Descripción

Ethnicity

Tipo de datos

integer

Alias
UMLS CUI [1]
C0015031
Race
Descripción

Race

Tipo de datos

integer

Alias
UMLS CUI [1]
C0034510
Other, specify
Descripción

Other Specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C0034510
Volver a la parte superior de la página

Similar models

Informed Consent and Demographics

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
Informed Consent Date
date
C0021430 (UMLS CUI [1])
Blood Sample Usage for Further Research
Item
Can blood samples be used for further research into FLU-LD vaccines or infection?
boolean
C0005834 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0021403 (UMLS CUI [2,1])
C0008972 (UMLS CUI [2,2])
C0021400 (UMLS CUI [3,1])
C0008972 (UMLS CUI [3,2])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
American Hispanic or Latino (1)
CL Item
Not American Hispanic or Latino (2)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
African Heritage / African American (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic / North African Heritage (8)
CL Item
White - Caucasian / European Heritage (9)
CL Item
Other (99)
Other Specification
Item
Other, specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0034510 (UMLS CUI [1,3])
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