ID

24020

Beschrijving

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

Trefwoorden

  1. 23-07-17 23-07-17 -
Geüploaded op

23 juli 2017

DOI

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Licentie

Creative Commons BY-NC 3.0

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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
Beschrijving

Concomitant Vaccination

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

Subject Number

Datatype

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?
Beschrijving

vaccine

Datatype

integer

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

Name

Datatype

text

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

Route

Datatype

text

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

Administration date

Datatype

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
Type
Description | Question | Decode (Coded Value)
Datatype
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])

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