ID

24462

Beschreibung

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

Stichworte

Versionen (3)
  1. 01.08.17 01.08.17 -
  2. 02.08.17 02.08.17 -
  3. 20.09.21 20.09.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

1. August 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

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

Englisch

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

1 Formulare  
Header
Beschreibung

Header

Alias
UMLS CUI-1
C1320722
Protocol
Beschreibung

Protocol

Datentyp

text

Alias
UMLS CUI [1]
C1507394
Activity
Beschreibung

Activity

Datentyp

text

Alias
UMLS CUI [1]
C1512346
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
VACCINE ADMINISTRATION
Beschreibung

VACCINE ADMINISTRATION

Alias
UMLS CUI-1
C2368628
Temperature :
Beschreibung

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

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Axillary route
Beschreibung

Axillary temperature

Datentyp

boolean

Alias
UMLS CUI [1]
C1531924
Oral route
Beschreibung

Oral temperature

Datentyp

boolean

Alias
UMLS CUI [1]
C1532216
Rectal route
Beschreibung

Rectal temperature

Datentyp

boolean

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

If Yes, complete the table below.

Datentyp

boolean

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

Study vaccine has not been administered

Datentyp

text

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

Hepatitis A and B vaccine

Datentyp

text

Alias
UMLS CUI [1]
C0593947
left
Beschreibung

Please specify side :

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0934109
UMLS CUI [1,2]
C0224234
UMLS CUI [1,3]
C0021492
right
Beschreibung

Please specify side :

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0923498
UMLS CUI [1,2]
C0224234
UMLS CUI [1,3]
C0021492
Date administered (day month year)
Beschreibung

Date administered (day month year)

Datentyp

date

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

Time (24 hr. clock)

Datentyp

time

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

Vaccine administration according to protocol

Datentyp

boolean

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

study vaccine has not been administered according to the protocol

Datentyp

text

Alias
UMLS CUI [1]
C2700396
Route :
Beschreibung

study vaccine has not been administered according to the protocol

Datentyp

text

Alias
UMLS CUI [1]
C1828121
POST VACCINATION OBSERVATION
Beschreibung

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 ?
Beschreibung

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

Datentyp

boolean

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

If Yes, please complete the Medication Section

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0420172
UMLS CUI [1,2]
C0413534
Zum Seitenanfang zurückkehren

Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 has not been administered
Item
Please specify and go to next page :
text
C0042210 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Hepatitis A and B vaccine
Item
HAB
text
C0593947 (UMLS CUI [1])
Deltoid I.M. left side
Item
left
boolean
C0934109 (UMLS CUI [1,1])
C0224234 (UMLS CUI [1,2])
C0021492 (UMLS CUI [1,3])
Deltoid I.M. right side
Item
right
boolean
C0923498 (UMLS CUI [1,1])
C0224234 (UMLS CUI [1,2])
C0021492 (UMLS CUI [1,3])
Date administered (day month year)
Item
Date administered (day month year)
date
C0011008 (UMLS CUI [1])
Time (24 hr. clock)
Item
Time (24 hr. clock)
time
C0040223 (UMLS CUI [1])
Vaccine administration according to protocol
Item
Has the study vaccine been administered according to the protocol ?
boolean
C2368628 (UMLS CUI [1])
C1507394 (UMLS CUI [2])
Vaccine not administered according to protocol
Item
Injection site :
text
C2700396 (UMLS CUI [1])
Vaccine not administered according to protocol
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video