ID

35818

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. 25/3/19 25/3/19 -
  2. 27/12/19 27/12/19 -
Titular de derechos de autor

GSK group of companies

Subido en

25 de marzo de 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

Visit
Descripción

Visit Type

Tipo de datos

text

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

Informed Consent Date :
Descripción

Informed Consent Date

Tipo de datos

date

DEMOGRAPHICS
Descripción

DEMOGRAPHICS

Date of birth:
Descripción

Birth Date

Tipo de datos

date

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

INVESTIGATOR SIGNATURE
Descripción

INVESTIGATOR SIGNATURE

Date
Descripción

Date

Tipo de datos

date

Investigator signature :
Descripción

Investigator signature

Tipo de datos

text

Long Term Follow-Up (Year 15)
Descripción

Long Term Follow-Up (Year 15)

Center
Descripción

Center Number

Tipo de datos

integer

Subject Initials
Descripción

First Name, Family Name

Tipo de datos

text

Subject Number
Descripción

Subject Number

Tipo de datos

integer

BLOOD SAMPLING
Descripción

BLOOD SAMPLING

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

Consent

Tipo de datos

boolean

Informed Consent Date:
Descripción

Informed Consent Date

Tipo de datos

date

DEMOGRAPHICS
Descripción

DEMOGRAPHICS

Date of birth:
Descripción

Birth Date

Tipo de datos

date

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

INVESTIGATOR SIGNATURE
Descripción

INVESTIGATOR SIGNATURE

Date
Descripción

Date

Tipo de datos

date

Investigator signature :
Descripción

Investigator signature

Tipo de datos

text

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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
Item
Visit
text
Visit Type
Code List
Visit
CL Item
Blood Sampling (Year 14) (1)
Visit Date
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Visit Date
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C1320303 (UMLS CUI [1])
Subject number
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Subject number
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C2348585 (UMLS CUI [1])
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BLOOD SAMPLING
Consent
Item
I certify that Informed Consent has been obtained prior to any study procedure.
boolean
Informed Consent Date
Item
Informed Consent Date :
date
Item Group
DEMOGRAPHICS
Birth Date
Item
Date of birth:
date
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Item Group
LABORATORY TESTS
BLOOD SAMPLE
Item
Has a blood sample been taken ?
boolean
Item Group
INVESTIGATOR SIGNATURE
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Item
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date
Investigator signature
Item
Investigator signature :
text
Item Group
Long Term Follow-Up (Year 15)
Center Number
Item
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integer
Subject identification
Item
Subject Initials
text
Subject Number
Item
Subject Number
integer
Item Group
BLOOD SAMPLING
Consent
Item
I certify that Informed Consent has been obtained prior to any study procedure.
boolean
Informed Consent Date
Item
Informed Consent Date:
date
Item Group
DEMOGRAPHICS
Birth Date
Item
Date of birth:
date
Subject Initials
Item
Subject Initials
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C2986440 (UMLS CUI [1])
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LABORATORY TESTS
BLOOD SAMPLE
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Has a blood sample been taken?
boolean
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Date
Item
Date
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Investigator signature
Item
Investigator signature :
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