ID

44006

Descripción

Visit 2 Vaccine Administration form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Palabras clave

Versiones (3)
  1. 1/8/17 1/8/17 -
  2. 2/8/17 2/8/17 -
  3. 20/9/21 20/9/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

20 de septiembre de 2021

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.

Visit 2 Vaccine Administration Biologicals HepA/HepB vaccine 208127/125

Inglés

Visit 2 Vaccine Administration Biologicals HepA/HepB vaccine 208127/125

1 formularios  
Header
Descripción

Header

Alias
UMLS CUI-1
C1320722
Protocol
Descripción

Protocol

Tipo de datos

text

Alias
UMLS CUI [1]
C1507394
Activity
Descripción

Activity

Tipo de datos

text

Alias
UMLS CUI [1]
C1512346
Subject number
Descripción

Subject number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
VACCINE ADMINISTRATION
Descripción

VACCINE ADMINISTRATION

Alias
UMLS CUI-1
C2368628
Temperature :
Descripción

As specified in the protocol, the temperature of the subject should be taken by the oral route.

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Axillary route
Descripción

Axillary temperature

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1531924
Oral route
Descripción

Oral temperature

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1532216
Rectal route
Descripción

Rectal temperature

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0489749
Has the study vaccine been administered ?
Descripción

If Yes, complete the table below.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0008972
Please specify and go to next page :
Descripción

Study vaccine has not been administered

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0008972
HAB
Descripción

Vaccine

Tipo de datos

text

Alias
UMLS CUI [1]
C5397396
Site/Route of injection: Deltoid I.M.
Descripción

Please specify side :

Tipo de datos

text

Alias
UMLS CUI [1]
C2700396
Date administered (day month year)
Descripción

Date administered

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Time (24 hr. clock)
Descripción

Time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
Has the study vaccine been administered according to the protocol ?
Descripción

Vaccine protocol

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2368628
UMLS CUI [2]
C1507394
Injection site :
Descripción

study vaccine has not been administered according to the protocol

Tipo de datos

text

Alias
UMLS CUI [1]
C2700396
Route :
Descripción

study vaccine has not been administered according to the protocol

Tipo de datos

text

Alias
UMLS CUI [1]
C1828121
POST VACCINATION OBSERVATION
Descripción

POST VACCINATION OBSERVATION

Alias
UMLS CUI-1
C1443955
UMLS CUI-2
C0700325
Has any adverse experience occurred during the immediate 30 minute post vaccination observation period ?
Descripción

If Yes, please fill in the Adverse Experience Section and detail the exact time of onset.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0151862
Has any prophylactic medication been administered in anticipation of study vaccine reactions ?
Descripción

If Yes, please complete the Medication Section

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0420172
UMLS CUI [1,2]
C0413534
Volver a la parte superior de la página

Similar models

Visit 2 Vaccine Administration Biologicals HepA/HepB vaccine 208127/125

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Protocol
Item
Protocol
text
C1507394 (UMLS CUI [1])
Activity
Item
Activity
text
C1512346 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
VACCINE ADMINISTRATION
C2368628 (UMLS CUI-1)
Temperature
Item
Temperature :
float
C0005903 (UMLS CUI [1])
Axillary temperature
Item
Axillary route
boolean
C1531924 (UMLS CUI [1])
Oral temperature
Item
Oral route
boolean
C1532216 (UMLS CUI [1])
Rectal temperature
Item
Rectal route
boolean
C0489749 (UMLS CUI [1])
Study vaccine administered
Item
Has the study vaccine been administered ?
boolean
C0042210 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Study vaccine not administered
Item
Please specify and go to next page :
text
C0042210 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Item
HAB
text
C5397396 (UMLS CUI [1])
Vaccine
Code List
HAB
CL Item
HAB (HAB)
Item
Site/Route of injection: Deltoid I.M.
text
C2700396 (UMLS CUI [1])
Site/Route of injection
Code List
Site/Route of injection: Deltoid I.M.
CL Item
left (left)
CL Item
right (right)
Date administered
Item
Date administered (day month year)
date
C0011008 (UMLS CUI [1])
Time
Item
Time (24 hr. clock)
time
C0040223 (UMLS CUI [1])
Vaccine protocol
Item
Has the study vaccine been administered according to the protocol ?
boolean
C2368628 (UMLS CUI [1])
C1507394 (UMLS CUI [2])
Injection site
Item
Injection site :
text
C2700396 (UMLS CUI [1])
Route
Item
Route :
text
C1828121 (UMLS CUI [1])
Item Group
POST VACCINATION OBSERVATION
C1443955 (UMLS CUI-1)
C0700325 (UMLS CUI-2)
Adverse experience after vaccination
Item
Has any adverse experience occurred during the immediate 30 minute post vaccination observation period ?
boolean
C0877248 (UMLS CUI [1,1])
C0151862 (UMLS CUI [1,2])
Prophylactic medication
Item
Has any prophylactic medication been administered in anticipation of study vaccine reactions ?
boolean
C0420172 (UMLS CUI [1,1])
C0413534 (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