ID

39350

Descripción

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 

Palabras clave

Versiones (2)
  1. 25.03.19 25.03.19 -
  2. 27.12.19 27.12.19 -
Titular de derechos de autor

GSK group of companies

Subido en

27. Dezember 2019

DOI

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Licencia

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

Inglés

Long Term Follow-Up

1 formularios  
  1. StudyEvent: ODM
    1. Long Term Follow-Up
Long Term Follow-Up (Year 14)
Descripción

Long Term Follow-Up (Year 14)

Center
Descripción

Center Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Visit
Descripción

Visit Type

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Visit Date
Descripción

Visit Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
BLOOD SAMPLING
Descripción

BLOOD SAMPLING

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

Consent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0150312
Informed Consent Date :
Descripción

Informed Consent Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2985782
DEMOGRAPHICS
Descripción

DEMOGRAPHICS

Date of birth:
Descripción

Birth Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Subject Initials
Descripción

Subject Initials

Tipo de datos

text

Unidades de medida
  • _ _ First Name / _ _ Family Name
Alias
UMLS CUI [1]
C2986440
_ _ First Name / _ _ Family Name
LABORATORY TESTS
Descripción

LABORATORY TESTS

Has a blood sample been taken ?
Descripción

BLOOD SAMPLE

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1272695
INVESTIGATOR SIGNATURE
Descripción

INVESTIGATOR SIGNATURE

Date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Investigator signature :
Descripción

Investigator signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Long Term Follow-Up (Year 15)
Descripción

Long Term Follow-Up (Year 15)

Center
Descripción

Center Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Subject Initials
Descripción

First Name, Family Name

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Subject Number
Descripción

Subject Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
BLOOD SAMPLING
Descripción

BLOOD SAMPLING

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

Consent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0150312
Informed Consent Date:
Descripción

Informed Consent Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2985782
DEMOGRAPHICS
Descripción

DEMOGRAPHICS

Date of birth:
Descripción

Birth Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Subject Initials
Descripción

Subject Initials

Tipo de datos

text

Unidades de medida
  • _ _ First Name / _ _ Family Name
Alias
UMLS CUI [1]
C2986440
_ _ First Name / _ _ Family Name
LABORATORY TESTS
Descripción

LABORATORY TESTS

Has a blood sample been taken?
Descripción

BLOOD SAMPLE

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1272695
INVESTIGATOR SIGNATURE
Descripción

INVESTIGATOR SIGNATURE

Date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Investigator signature :
Descripción

Investigator signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
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Long Term Follow-Up

1 formularios
  1. StudyEvent: ODM
    1. Long Term Follow-Up
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Long Term Follow-Up (Year 14)
Center Number
Item
Center
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item
Visit
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit Type
Code List
Visit
CL Item
Blood Sampling (Year 14) (1)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
BLOOD SAMPLING
Consent
Item
I certify that Informed Consent has been obtained prior to any study procedure.
boolean
C0021430 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Informed Consent Date
Item
Informed Consent Date :
date
C2985782 (UMLS CUI [1])
Item Group
DEMOGRAPHICS
Birth Date
Item
Date of birth:
date
C0421451 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Item Group
LABORATORY TESTS
BLOOD SAMPLE
Item
Has a blood sample been taken ?
boolean
C0005834 (UMLS CUI [1,1])
C1272695 (UMLS CUI [1,2])
Item Group
INVESTIGATOR SIGNATURE
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Investigator signature
Item
Investigator signature :
text
C2346576 (UMLS CUI [1])
Item Group
Long Term Follow-Up (Year 15)
Center Number
Item
Center
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject identification
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
BLOOD SAMPLING
Consent
Item
I certify that Informed Consent has been obtained prior to any study procedure.
boolean
C0021430 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Informed Consent Date
Item
Informed Consent Date:
date
C2985782 (UMLS CUI [1])
Item Group
DEMOGRAPHICS
Birth Date
Item
Date of birth:
date
C0421451 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Item Group
LABORATORY TESTS
BLOOD SAMPLE
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1,1])
C1272695 (UMLS CUI [1,2])
Item Group
INVESTIGATOR SIGNATURE
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Investigator signature
Item
Investigator signature :
text
C2346576 (UMLS CUI [1])
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