ID

35818

Description

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 

Keywords

Versions (2)
  1. 3/25/19 3/25/19 -
  2. 12/27/19 12/27/19 -
Copyright Holder

GSK group of companies

Uploaded on

March 25, 2019

DOI

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License

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

English

Long Term Follow-Up

1 forms  
  1. StudyEvent: ODM
    1. Long Term Follow-Up
Long Term Follow-Up (Year 14)
Description

Long Term Follow-Up (Year 14)

Center
Description

Center Number

Data type

integer

Visit
Description

Visit Type

Data type

text

Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
BLOOD SAMPLING
Description

BLOOD SAMPLING

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

Consent

Data type

boolean

Informed Consent Date :
Description

Informed Consent Date

Data type

date

DEMOGRAPHICS
Description

DEMOGRAPHICS

Date of birth:
Description

Birth Date

Data type

date

Subject Initials
Description

Subject Initials

Data type

text

Measurement units
  • _ _ First Name / _ _ Family Name
Alias
UMLS CUI [1]
C2986440
_ _ First Name / _ _ Family Name
LABORATORY TESTS
Description

LABORATORY TESTS

Has a blood sample been taken ?
Description

BLOOD SAMPLE

Data type

boolean

INVESTIGATOR SIGNATURE
Description

INVESTIGATOR SIGNATURE

Date
Description

Date

Data type

date

Investigator signature :
Description

Investigator signature

Data type

text

Long Term Follow-Up (Year 15)
Description

Long Term Follow-Up (Year 15)

Center
Description

Center Number

Data type

integer

Subject Initials
Description

First Name, Family Name

Data type

text

Subject Number
Description

Subject Number

Data type

integer

BLOOD SAMPLING
Description

BLOOD SAMPLING

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

Consent

Data type

boolean

Informed Consent Date:
Description

Informed Consent Date

Data type

date

DEMOGRAPHICS
Description

DEMOGRAPHICS

Date of birth:
Description

Birth Date

Data type

date

Subject Initials
Description

Subject Initials

Data type

text

Measurement units
  • _ _ First Name / _ _ Family Name
Alias
UMLS CUI [1]
C2986440
_ _ First Name / _ _ Family Name
LABORATORY TESTS
Description

LABORATORY TESTS

Has a blood sample been taken?
Description

BLOOD SAMPLE

Data type

boolean

INVESTIGATOR SIGNATURE
Description

INVESTIGATOR SIGNATURE

Date
Description

Date

Data type

date

Investigator signature :
Description

Investigator signature

Data type

text

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Similar models

Long Term Follow-Up

1 forms
  1. StudyEvent: ODM
    1. Long Term Follow-Up
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
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
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
Date
Item
Date
date
Investigator signature
Item
Investigator signature :
text
Item Group
Long Term Follow-Up (Year 15)
Center Number
Item
Center
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
text
C2986440 (UMLS CUI [1])
Item Group
LABORATORY TESTS
BLOOD SAMPLE
Item
Has a blood sample been taken?
boolean
Item Group
INVESTIGATOR SIGNATURE
Date
Item
Date
date
Investigator signature
Item
Investigator signature :
text
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