ID
35264
Description
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
Keywords
Versions (1)
- 2/25/19 2/25/19 -
Copyright Holder
GSK group of companies
Uploaded on
February 25, 2019
DOI
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License
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
Description
INFORMED CONSENT
Description
DEMOGRAPHICS
Description
PREVIOUS STUDY: 103860/272 (EXT: HBV-115) Subject number will be the same as in the previous study.
Data type
date
Description
Gender
Data type
text
Description
Race
Data type
text
Description
OtherRace
Data type
text
Description
Height
Data type
integer
Measurement units
- cm
Description
Weight
Data type
float
Measurement units
- kg
Description
LABORATORY TESTS
Description
BLOOD SAMPLE
Data type
boolean
Description
DateBloodSampleTaken
Data type
date
Description
PreviousHepatitisVaccination
Data type
boolean
Description
PreviousHistoryOfHipatitisB
Data type
boolean
Description
Specify
Data type
text
Description
Visit 23 (Year 17) Follow-up
Description
LABORATORY TESTS
Description
BLOOD SAMPLE
Data type
boolean
Description
DateBloodSampleTaken
Data type
date
Description
PreviousHepatitisBVaccination
Data type
boolean
Description
PreviousHistoryOfHepatitisB
Data type
boolean
Description
Specify
Data type
text
Description
Visit 24 (Year 18) Follow-up
Description
LABORATORY TESTS
Description
BLOOD SAMPLE
Data type
boolean
Description
DateBloodSampleTaken
Data type
date
Description
PreviousHepatitisBVaccination
Data type
boolean
Description
PreviousHistoryOfHepatitisB
Data type
boolean
Description
Specify
Data type
text
Description
Visit 25 (Year 19) Follow-up
Description
LABORATORY TESTS
Description
BLOOD SAMPLE
Data type
boolean
Description
DateBloodSampleTaken
Data type
date
Description
PreviousHepatitisBVaccination
Data type
boolean
Description
PreviousHistoryOfHepatitisB
Data type
boolean
Description
Specify
Data type
text
Description
Visit 26 (Year 20) Follow-up
Description
LABORATORY TESTS
Description
BLOOD SAMPLE
Data type
boolean
Description
DateBloodSampleTaken
Data type
date
Description
PreviousHepatitisBVaccination
Data type
boolean
Description
PreviousHistoryOfHepatitisB
Data type
boolean
Description
Specify
Data type
text
Description
FOLLOW-UP STUDIES
Description
FollowUpStudiesParticipation
Data type
boolean
Description
If No, please specify
Data type
text
Description
AE/SAE
Data type
text
Description
OtherSpecify
Data type
text
Description
INVESTIGATOR'S SIGNATURE
Description
Investigator'sConfirmationDate
Data type
date
Description
Investigator's signature
Data type
text
Description
Printed Investigator's name
Data type
text
Description
Reason for non participation
Description
Tracking Document
Description
Previous Subject Number
Data type
integer
Description
BirthDate
Data type
date
Description
Please document reason for non participation
Data type
text
Description
DeathDate
Data type
date
Description
Date of Contact
Data type
date
Description
Investigator's Signature
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Visit 22 - 26 (Follow-Up)
- StudyEvent: ODM