ID

25690

Beschreibung

Visit 7 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731 Study ID: 100382 Clinical Study ID: 100382 Study Title: Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of GSK Biologicals’ Combined Hepatitis A & B Vaccine, vs Separately Administered Monovalent Hepatitis A and Hepatitis B Vaccines Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289731 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Stichworte

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  1. 10.09.17 10.09.17 -
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glaxoSmithKline

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10. September 2017

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Visit 7 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731

Englisch

Visit 7 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731

1 Formulare  
Informed consent
Beschreibung

Informed consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Beschreibung

I certify that Informed Consent has been obtained prior to any study procedure.

Datentyp

date

Alias
UMLS CUI [1]
C2985782
Demographics
Beschreibung

Demographics

Alias
UMLS CUI-1
C0011298
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

Race

Datentyp

integer

Alias
UMLS CUI [1]
C0034510
Other Race, please specify
Beschreibung

If you chose 'Other Race', please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C3845569
Laboratory tests
Beschreibung

Laboratory tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Beschreibung

Blood sample

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Date blood sample taken
Beschreibung

Please complete only if different from visit date

Datentyp

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Has the subject received a dose of monovalent or combined Hepatitis A vaccine since the last visit?
Beschreibung

Hepatitis A vaccine monovalent or recombined

Datentyp

boolean

Alias
UMLS CUI [1]
C0170300
Please specify type of Hepatis A vaccine.
Beschreibung

Specify hepatitis a vaccine

Datentyp

integer

Alias
UMLS CUI [1,1]
C0170300
UMLS CUI [1,2]
C1521902
Follow-up- Studies
Beschreibung

Follow-up- Studies

Alias
UMLS CUI-1
C0016441
UMLS CUI-2
C0042210
Would the subject be willing to participate in a follow-up study?
Beschreibung

If "No", please specify the most appropriate reason.

Datentyp

boolean

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

Reason for non participation in follow-up

Datentyp

integer

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0566251
Please specify Adverse Events, or Serious Adverse Events.
Beschreibung

specify Adverse Events

Datentyp

text

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C1521902
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C1521902
Specify other reason
Beschreibung

Other reason for no follow-up

Datentyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Occurrence of serious adverse event
Beschreibung

Occurrence of serious adverse event

Alias
UMLS CUI-1
C1519255
Did the subject experience any Serious Adverse Event since last visit?
Beschreibung

Serious adverse event

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
If yes, please give the total number of SAE's.
Beschreibung

Number of SAE

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
Pregnancy information
Beschreibung

Pregnancy information

Alias
UMLS CUI-1
C0032961
Did the subject become pregnant since last visit?
Beschreibung

If yes, please complete the Pregnancy Notification form.

Datentyp

integer

Alias
UMLS CUI [1]
C0032961
Elimination criteria
Beschreibung

Elimination criteria

Alias
UMLS CUI-1
C0680251
Did any elimination criteria become applicable during the study?
Beschreibung

Elimination criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Please specify elimination criteria.
Beschreibung

specify elimination criteria

Datentyp

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1521902
Investigator's signature
Beschreibung

Investigator's signature

Alias
UMLS CUI-1
C2346576
Investigator's 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
Printed Investigator's name
Beschreibung

Printed Investigator's name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Date
Beschreibung

Date of investigator's signature

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Reason for non participation
Beschreibung

Reason for non participation

Alias
UMLS CUI-1
C0558080
UMLS CUI-2
C0679823
UMLS CUI-3
C0392360
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Reason for non participation
Beschreibung

Reason for non participation

Datentyp

integer

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Please specify criteria for non-eligibility.
Beschreibung

Subject not eligible? - please specify criteria that are not fullfilled:

Datentyp

text

Alias
UMLS CUI [1,1]
C1555471
UMLS CUI [1,2]
C1521902
Subject eligible but not willing to participate due to: Please specify:
Beschreibung

Only fill in, if you chose "Subject eligible but not willing to participate due to: Please specify:" before.

Datentyp

text

Alias
UMLS CUI [1,1]
C3846156
UMLS CUI [1,2]
C0392360
Please specify serious adverse event which is the reason for the subject being not willing to participate
Beschreibung

Only fill in, if you chose "adverse events, or serious adverse event: please specify" before.

Datentyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C1521902
Please specify other reason for subject not willing to participate
Beschreibung

Only fill in if you chose "other" before.

Datentyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
UMLS CUI [1,3]
C2348568
Date of death
Beschreibung

Only fill in, if you chose "Subject died on:" before.

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Date of contact
Beschreibung

Date of contact

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
UMLS CUI [1,3]
C2348568
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Ähnliche Modelle

Visit 7 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Informed consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Black (1)
CL Item
Arabic/North African (4)
CL Item
White/Caucasian (2)
CL Item
East & South East Asian (5)
CL Item
South Asian (6)
CL Item
Other (9)
Other Race
Item
Other Race, please specify
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
Item Group
Laboratory tests
C0022885 (UMLS CUI-1)
Blood sample
Item
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
boolean
C0005834 (UMLS CUI [1])
Date blood sample taken
Item
Date blood sample taken
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Hepatitis A vaccine monovalent or recombined
Item
Has the subject received a dose of monovalent or combined Hepatitis A vaccine since the last visit?
boolean
C0170300 (UMLS CUI [1])
Item
Please specify type of Hepatis A vaccine.
integer
C0170300 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Specify hepatitis a vaccine
Code List
Please specify type of Hepatis A vaccine.
CL Item
Hepatitis A vaccine (1)
CL Item
Hepatitis B vaccine (2)
CL Item
Combined Hepatitis A and B vaccine (3)
Item Group
Follow-up- Studies
C0016441 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
willing to participate in a 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])
C0566251 (UMLS CUI [1,3])
Reason for non participation in follow-up
Code List
Please specify the most appropriate reason.
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Others (2)
specify Adverse Events
Item
Please specify Adverse Events, or Serious Adverse Events.
text
C0559546 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1521902 (UMLS CUI [2,2])
Other reason for no follow-up
Item
Specify other reason
text
C2348568 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Occurrence of serious adverse event
C1519255 (UMLS CUI-1)
Serious adverse event
Item
Did the subject experience any Serious Adverse Event since last visit?
boolean
C1519255 (UMLS CUI [1])
Number of SAE
Item
If yes, please give the total number of SAE's.
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Pregnancy information
C0032961 (UMLS CUI-1)
Item
Did the subject become pregnant since last visit?
integer
C0032961 (UMLS CUI [1])
Pregnancy
Code List
Did the subject become pregnant since last visit?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (not of childbearing potential or male) (3)
Item Group
Elimination criteria
C0680251 (UMLS CUI-1)
Elimination criteria
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1])
specify elimination criteria
Item
Please specify elimination criteria.
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Date of investigator's signature
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Reason for non participation
C0558080 (UMLS CUI-1)
C0679823 (UMLS CUI-2)
C0392360 (UMLS CUI-3)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Reason for non participation
integer
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Reason for non participation
Code List
Reason for non participation
CL Item
Subject not eligible? - please specify criteria that are not fulfilled: (1)
CL Item
Subject lost to follow-up or not reached (2)
CL Item
Subject eligible but not willing to participate due to: (3)
CL Item
Subject died on: (4)
specify criteria non eligible
Item
Please specify criteria for non-eligibility.
text
C1555471 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
not willing to participate
Item
Subject eligible but not willing to participate due to: Please specify:
text
C3846156 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
specify serious adverse event
Item
Please specify serious adverse event which is the reason for the subject being not willing to participate
text
C2348568 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
specify other reason
Item
Please specify other reason for subject not willing to participate
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Date of contact
Item
Date of contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
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