ID

35818

Beskrivning

Study ID: 103860-115 Clinical Study ID: 103860-115 Study Title: Immunogenicity and protective efficacy of GlaxoSmithKline (previously SmithKlineBeecham) Biologicals’ hepatitis B vaccine (10mcg) in newborn of HBeAg and HBsAg positive mothers compared with a historical control group. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: N/A Study Indication: Hepatitis B 

Nyckelord

Versioner (2)
  1. 2019-03-25 2019-03-25 -
  2. 2019-12-27 2019-12-27 -
Rättsinnehavare

GSK group of companies

Uppladdad den

25 mars 2019

DOI

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Creative Commons BY-NC 3.0
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Hepatitis B vaccine in newborn of HBeAg and HBsAg positive mothers - 103860-115

Engelsk

Long Term Follow-Up

1 Formulär  
  1. StudyEvent: ODM
    1. Long Term Follow-Up
Long Term Follow-Up (Year 14)
Beskrivning

Long Term Follow-Up (Year 14)

Center
Beskrivning

Center Number

Datatyp

integer

Visit
Beskrivning

Visit Type

Datatyp

text

Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beskrivning

Subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
BLOOD SAMPLING
Beskrivning

BLOOD SAMPLING

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

Consent

Datatyp

boolean

Informed Consent Date :
Beskrivning

Informed Consent Date

Datatyp

date

DEMOGRAPHICS
Beskrivning

DEMOGRAPHICS

Date of birth:
Beskrivning

Birth Date

Datatyp

date

Subject Initials
Beskrivning

Subject Initials

Datatyp

text

Måttenheter
  • _ _ First Name / _ _ Family Name
Alias
UMLS CUI [1]
C2986440
_ _ First Name / _ _ Family Name
LABORATORY TESTS
Beskrivning

LABORATORY TESTS

Has a blood sample been taken ?
Beskrivning

BLOOD SAMPLE

Datatyp

boolean

INVESTIGATOR SIGNATURE
Beskrivning

INVESTIGATOR SIGNATURE

Date
Beskrivning

Date

Datatyp

date

Investigator signature :
Beskrivning

Investigator signature

Datatyp

text

Long Term Follow-Up (Year 15)
Beskrivning

Long Term Follow-Up (Year 15)

Center
Beskrivning

Center Number

Datatyp

integer

Subject Initials
Beskrivning

First Name, Family Name

Datatyp

text

Subject Number
Beskrivning

Subject Number

Datatyp

integer

BLOOD SAMPLING
Beskrivning

BLOOD SAMPLING

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

Consent

Datatyp

boolean

Informed Consent Date:
Beskrivning

Informed Consent Date

Datatyp

date

DEMOGRAPHICS
Beskrivning

DEMOGRAPHICS

Date of birth:
Beskrivning

Birth Date

Datatyp

date

Subject Initials
Beskrivning

Subject Initials

Datatyp

text

Måttenheter
  • _ _ First Name / _ _ Family Name
Alias
UMLS CUI [1]
C2986440
_ _ First Name / _ _ Family Name
LABORATORY TESTS
Beskrivning

LABORATORY TESTS

Has a blood sample been taken?
Beskrivning

BLOOD SAMPLE

Datatyp

boolean

INVESTIGATOR SIGNATURE
Beskrivning

INVESTIGATOR SIGNATURE

Date
Beskrivning

Date

Datatyp

date

Investigator signature :
Beskrivning

Investigator signature

Datatyp

text

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Long Term Follow-Up

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Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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Long Term Follow-Up (Year 14)
Center Number
Item
Center
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Visit
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I certify that Informed Consent has been obtained prior to any study procedure.
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