ID

35818

Beschrijving

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 

Trefwoorden

Versies (2)
  1. 25-03-19 25-03-19 -
  2. 27-12-19 27-12-19 -
Houder van rechten

GSK group of companies

Geüploaded op

25 maart 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Hepatitis B vaccine in newborn of HBeAg and HBsAg positive mothers - 103860-115

Engels

Long Term Follow-Up

1 Formulieren  
  1. StudyEvent: ODM
    1. Long Term Follow-Up
Long Term Follow-Up (Year 14)
Beschrijving

Long Term Follow-Up (Year 14)

Center
Beschrijving

Center Number

Datatype

integer

Visit
Beschrijving

Visit Type

Datatype

text

Visit Date
Beschrijving

Visit Date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
BLOOD SAMPLING
Beschrijving

BLOOD SAMPLING

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

Consent

Datatype

boolean

Informed Consent Date :
Beschrijving

Informed Consent Date

Datatype

date

DEMOGRAPHICS
Beschrijving

DEMOGRAPHICS

Date of birth:
Beschrijving

Birth Date

Datatype

date

Subject Initials
Beschrijving

Subject Initials

Datatype

text

Maateenheden
  • _ _ First Name / _ _ Family Name
Alias
UMLS CUI [1]
C2986440
_ _ First Name / _ _ Family Name
LABORATORY TESTS
Beschrijving

LABORATORY TESTS

Has a blood sample been taken ?
Beschrijving

BLOOD SAMPLE

Datatype

boolean

INVESTIGATOR SIGNATURE
Beschrijving

INVESTIGATOR SIGNATURE

Date
Beschrijving

Date

Datatype

date

Investigator signature :
Beschrijving

Investigator signature

Datatype

text

Long Term Follow-Up (Year 15)
Beschrijving

Long Term Follow-Up (Year 15)

Center
Beschrijving

Center Number

Datatype

integer

Subject Initials
Beschrijving

First Name, Family Name

Datatype

text

Subject Number
Beschrijving

Subject Number

Datatype

integer

BLOOD SAMPLING
Beschrijving

BLOOD SAMPLING

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

Consent

Datatype

boolean

Informed Consent Date:
Beschrijving

Informed Consent Date

Datatype

date

DEMOGRAPHICS
Beschrijving

DEMOGRAPHICS

Date of birth:
Beschrijving

Birth Date

Datatype

date

Subject Initials
Beschrijving

Subject Initials

Datatype

text

Maateenheden
  • _ _ First Name / _ _ Family Name
Alias
UMLS CUI [1]
C2986440
_ _ First Name / _ _ Family Name
LABORATORY TESTS
Beschrijving

LABORATORY TESTS

Has a blood sample been taken?
Beschrijving

BLOOD SAMPLE

Datatype

boolean

INVESTIGATOR SIGNATURE
Beschrijving

INVESTIGATOR SIGNATURE

Date
Beschrijving

Date

Datatype

date

Investigator signature :
Beschrijving

Investigator signature

Datatype

text

Terug naar het begin van de pagina

Similar models

Long Term Follow-Up

1 Formulieren
  1. StudyEvent: ODM
    1. Long Term Follow-Up
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial