ID

23420

Beschreibung

Clinical Study ID: 100450 Study Title: Comparative study of the immunogenicity and protective efficacy of GlaxoSmithKline Biologicals’ rec-DNA hepatitis B vaccine with or without hepatitis B immunoglobulins (HBIg) in newborns of HBeAg+ mothers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00240526 https://clinicaltrials.gov/ct2/show/NCT00240526 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B Documentation part: Visit 26, Year 20, Long Term Follow-Up, 20 Years +/- 6 Months

Link

https://clinicaltrials.gov/ct2/show/NCT00240526

Stichworte

Versionen (2)
  1. 04.07.17 04.07.17 -
  2. 04.07.17 04.07.17 -
Hochgeladen am

4. Juli 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Rec-DNA hepatitis B vaccine with or without hepatitis B immunoglobulins Visit 26 NCT00240526

Englisch

Visit 26 Rec-DNA hepatitis B vaccine with or without hepatitis B immunoglobulins NCT00240526

1 Formulare  
Laboratory Tests
Beschreibung

Laboratory Tests

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005834
UMLS CUI-3
C0474232
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0011008
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Has a blood sample been taken?
Beschreibung

blood sample

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Date sample taken
Beschreibung

Please complete only if different from visit date

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Did the subject receive a dose of Hepatitis B vaccine since the last visit
Beschreibung

Hepatitis B vaccine

Datentyp

boolean

Alias
UMLS CUI [1]
C2240392
Did the subject develop clinical signs possibly related to hepatitis B since last visit or suffered from hepatitis B?
Beschreibung

hepatitis B

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C1457887
UMLS CUI [2]
C0267797
If Yes, please specify
Beschreibung

Did the subject develop clinical signs possibly related to hepatitis B since last visit or suffered from hepatitis B?

Datentyp

text

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C1457887
UMLS CUI [2]
C0267797
Would the subject be willing to participate in a follow-up study?
Beschreibung

follow-up study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
Please specify the most appropriate reason
Beschreibung

If No, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0392360
Please specify if Adverse Events, or Serious Adverse Events
Beschreibung

If participate in a follow-up study=No, please specify the most appropriate reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0392360
Please specify if Other
Beschreibung

If participate in a follow-up study=No, please specify the most appropriate reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0392360
Investigators signature
Beschreibung

I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

Datentyp

text

Alias
UMLS CUI [1]
C2346576
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Ähnliche Modelle

Visit 26 Rec-DNA hepatitis B vaccine with or without hepatitis B immunoglobulins NCT00240526

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0474232 (UMLS CUI-3)
Date of Visit
Item
Date of Visit
date
C0545082 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Hepatitis B vaccine
Item
Did the subject receive a dose of Hepatitis B vaccine since the last visit
boolean
C2240392 (UMLS CUI [1])
hepatitis B
Item
Did the subject develop clinical signs possibly related to hepatitis B since last visit or suffered from hepatitis B?
boolean
C0019163 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0267797 (UMLS CUI [2])
hepatitis B
Item
If Yes, please specify
text
C0019163 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0267797 (UMLS CUI [2])
follow-up study
Item
Would the subject be willing to participate in a follow-up study?
boolean
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Item
Please specify the most appropriate reason
integer
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
participate in a follow-up study
Code List
Please specify the most appropriate reason
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Other (2)
reason
Item
Please specify if Adverse Events, or Serious Adverse Events
text
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
reason
Item
Please specify if Other
text
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Investigators signature
Item
Investigators signature
text
C2346576 (UMLS CUI [1])
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