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ID
35264
Beschrijving
Study ID: 100449 Clinical Study ID: 100449 Study Title: Long-term Follow-Up studies at Years 16-20, to evaluate the persistence of immune response of GSK Biologicals’ hepatitis B vaccine in newborns of HBeAg+ and HBsAg+ mothers in comparison with a historical control group Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00240539 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
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Versies (1)
- 25-02-19 25-02-19 -
Houder van rechten
GSK group of companies
Geüploaded op
25 februari 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Persistence of immune response of Hepatitis B vaccine in newborns of HBeAg+ and HBsAg+ mothers
Visit 22 - 26 (Follow-Up)
- StudyEvent: ODM
Similar models
Visit 22 - 26 (Follow-Up)
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Protocol
Item
Protocol
integer
Center
Item
Center
integer
Date of visit
Item
Date of visit
date
Subject Number
Item
Subject Number
integer
I certify that Informed Consent has been obtained prior to any study procedure.
Item
I certify that Informed Consent has been obtained prior to any study procedure.
boolean
InformedConsentDate
Item
Informed Consent Date
date
Date of birth:
Item
Date of birth:
date
CL Item
Male (1)
CL Item
Female (2)
CL Item
Black (1)
CL Item
Arabic/North African (2)
CL Item
White/Caucasian (3)
CL Item
East & South East Asian (4)
CL Item
South Asian (5)
OtherRace
Item
If Other, please specify race
text
Height
Item
Height
integer
Weight
Item
Weight
float
BLOOD SAMPLE
Item
Has a blood sample been taken?
boolean
DateBloodSampleTaken
Item
If Yes, please record the date
date
PreviousHepatitisVaccination
Item
Did the subject receive a dose of Hepatitis B vaccine since the last visit
boolean
PreviousHistoryOfHipatitisB
Item
Did the subject develop clinical signs possibly related to hepatitis B since last visit or suffered from hepatitis B?
boolean
Specify
Item
If Yes, please specify below
text
VisitDate
Item
Date of visit
date
BLOOD SAMPLE
Item
Has a blood sample been taken?
boolean
DateBloodSampleTaken
Item
Please specify the date of blood sample taken
date
PreviousHepatitisBVaccination
Item
Did the subject receive a dose of Hepatitis B vaccine since the last visit
boolean
PreviousHistoryOfHepatitisB
Item
Did the subject develop clinical signs possibly related to hepatitis B since last visit or suffered from hepatitis B?
boolean
Specify
Item
If Yes, please specify
text
Visit Date
Item
Date of visit
date
BLOOD SAMPLE
Item
Has a blood sample been taken?
boolean
DateBloodSampleTaken
Item
Please specify the date of blood sample taken
date
PreviousHepatitisBVaccination
Item
Did the subject receive a dose of Hepatitis B vaccine since the last visit
boolean
PreviousHistoryOfHepatitisB
Item
Did the subject develop clinical signs possibly related to hepatitis B since last visit or suffered from hepatitis B?
boolean
Specify
Item
If Yes, please specify
text
VisitDate
Item
Date of visit
date
BLOOD SAMPLE
Item
Has a blood sample been taken?
boolean
DateBloodSampleTaken
Item
Please specify the date of blood sample taken
date
PreviousHepatitisBVaccination
Item
Did the subject receive a dose of Hepatitis B vaccine since the last visit
boolean
PreviousHistoryOfHepatitisB
Item
Did the subject develop clinical signs possibly related to hepatitis B since last visit or suffered from hepatitis B?
boolean
Specify
Item
If Yes, please specify
text
VisitDate
Item
Date of visit
date
BLOOD SAMPLE
Item
Has a blood sample been taken?
boolean
DateBloodSampleTaken
Item
Please specify the date of blood sample taken
date
PreviousHepatitisBVaccination
Item
Did the subject receive a dose of Hepatitis B vaccine since the last visit
boolean
PreviousHistoryOfHepatitisB
Item
Did the subject develop clinical signs possibly related to hepatitis B since last visit or suffered from hepatitis B?
boolean
Specify
Item
If Yes, please specify
text
FollowUpStudiesParticipation
Item
Would the subject be willing to participate in a follow-up study?
boolean
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Other (2)
AE/SAE
Item
If AE or SAE, please specify
text
OtherSpecify
Item
If Other, please specify
text
Investigator'sConfirmationDate
Item
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.
date
Investigator's signature
Item
Investigator's signature
text
Printed Investigator's name
Item
Printed Investigator's name
text
Protocol number
Item
Protocol number
integer
Center
Item
Center
integer
Previous study
Item
Previous study
text
Previous Subject Number
Item
Previous Subject Number
integer
BirthDate
Item
Date of Birth
date
CL Item
Subject not eligible (1)
CL Item
Subject lost to follow-up or not reached (2)
CL Item
Subject eligible but not willing to participate due to adverse events, or serious adverse event (3)
CL Item
Subject eligible but not willing to participate due to other reasons (4)
CL Item
Subject died (5)
DeathDate
Item
In case of death, please specify date
date
Date of Contact
Item
Date of Contact
date
Investigator name
Item
Investigator name
text
Signature:
Item
Signature:
text
Date:
Item
Date:
date