ID

24020

Beskrivning

Study ID: 101377 Clinical Study ID: 101377 Study Title: A phase III, open, randomized, multicentre study to demonstrate the non-inferiority of GSK Biologicals' combined hepatitis A and hepatitis B vaccine according to a 0-1-6 month schedule, to the monovalent hepatitis A vaccine Havrix and hepatitis B vaccine Engerix separately administered, in healthy adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name:BIO HAB; Twinrix Study Indication: Hepatitis A; Hepatitis B Documentation part: Concomitant Vaccination

Nyckelord

  1. 2017-07-23 2017-07-23 -
Uppladdad den

23 juli 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Non-inferiority of GSK Biologicals' combined hepatitis A and hepatitis B vaccine to Havrix and Engerix in healthy adults Concomitant Vaccination 101377

Concomitant Vaccination Non-inferiority of GSK Biologicals' combined hepatitis A and hepatitis B vaccine to Havrix and Engerix in healthy adults 101377

Concomitant Vaccination
Beskrivning

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Subject Number
Beskrivning

Subject Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
Beskrivning

vaccine

Datatyp

integer

Alias
UMLS CUI [1]
C0042210
Trade/Generic Name
Beskrivning

Name

Datatyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0042210
Route
Beskrivning

Route

Datatyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Administration date
Beskrivning

Administration date

Datatyp

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0042210

Similar models

Concomitant Vaccination Non-inferiority of GSK Biologicals' combined hepatitis A and hepatitis B vaccine to Havrix and Engerix in healthy adults 101377

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
integer
C0042210 (UMLS CUI [1])
Code List
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
CL Item
No (1)
CL Item
Yes, please record concomitant vaccination with trade name and / or generic name, and vaccine administration date. (2)
Name
Item
Trade/Generic Name
text
C0027365 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Code List
Route
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Unknown (UNK)
Administration date
Item
Administration date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

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