ID

25690

Descripción

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

Palabras clave

Versiones (1)
  1. 10/9/17 10/9/17 -
Titular de derechos de autor

glaxoSmithKline

Subido en

10 de septiembre de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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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

Inglés

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 formularios  
Informed consent
Descripción

Informed consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Descripción

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

Tipo de datos

date

Alias
UMLS CUI [1]
C2985782
Demographics
Descripción

Demographics

Alias
UMLS CUI-1
C0011298
Date of Birth
Descripción

Date of Birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Gender
Descripción

Gender

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
Race
Descripción

Race

Tipo de datos

integer

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

If you chose 'Other Race', please specify

Tipo de datos

text

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

Laboratory tests

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

Blood sample

Tipo de datos

boolean

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

Please complete only if different from visit date

Tipo de datos

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?
Descripción

Hepatitis A vaccine monovalent or recombined

Tipo de datos

boolean

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

Specify hepatitis a vaccine

Tipo de datos

integer

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

Follow-up- Studies

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

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

Tipo de datos

boolean

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

Reason for non participation in follow-up

Tipo de datos

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.
Descripción

specify Adverse Events

Tipo de datos

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
Descripción

Other reason for no follow-up

Tipo de datos

text

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

Occurrence of serious adverse event

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

Serious adverse event

Tipo de datos

boolean

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

Number of SAE

Tipo de datos

integer

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

Pregnancy information

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

If yes, please complete the Pregnancy Notification form.

Tipo de datos

integer

Alias
UMLS CUI [1]
C0032961
Elimination criteria
Descripción

Elimination criteria

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

Elimination criteria

Tipo de datos

boolean

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

specify elimination criteria

Tipo de datos

text

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

Investigator's signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Descripción

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.

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Printed Investigator's name
Descripción

Printed Investigator's name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
Date
Descripción

Date of investigator's signature

Tipo de datos

date

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

Reason for non participation

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

Subject number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Date of Birth
Descripción

Date of Birth

Tipo de datos

date

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

Reason for non participation

Tipo de datos

integer

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

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

Tipo de datos

text

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

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Only fill in if you chose "other" before.

Tipo de datos

text

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

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

Tipo de datos

date

Alias
UMLS CUI [1]
C1148348
Date of contact
Descripción

Date of contact

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
UMLS CUI [1,3]
C2348568
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Similar models

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 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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