ID

39350

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

December 27, 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

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

Visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
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

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

Informed Consent Date

Data type

date

Alias
UMLS CUI [1]
C2985782
DEMOGRAPHICS
Description

DEMOGRAPHICS

Date of birth:
Description

Birth Date

Data type

date

Alias
UMLS CUI [1]
C0421451
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

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

INVESTIGATOR SIGNATURE

Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Investigator signature :
Description

Investigator signature

Data type

text

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

Long Term Follow-Up (Year 15)

Center
Description

Center Number

Data type

integer

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

First Name, Family Name

Data type

text

Alias
UMLS CUI [1]
C2986440
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

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

Informed Consent Date

Data type

date

Alias
UMLS CUI [1]
C2985782
DEMOGRAPHICS
Description

DEMOGRAPHICS

Date of birth:
Description

Birth Date

Data type

date

Alias
UMLS CUI [1]
C0421451
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

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

INVESTIGATOR SIGNATURE

Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Investigator signature :
Description

Investigator signature

Data type

text

Alias
UMLS CUI [1]
C2346576
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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
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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