ID

29433

Description

Long term follow-up Visit 6 Month 30 Study ID: 101695 Ext. Mth30 Clinical Study ID: 101695 Study Title: Long-term study of immune response persistence of GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines in subjects aged 11-15 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00343915 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

Mots-clés

Versions (1)
  1. 24/03/2018 24/03/2018 -
Détendeur de droits

GlaxoSmithKline (GSK)

Téléchargé le

24 mars 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines Study ID: 101695 NCT00343915

Anglais

Long term follow-up Visit 6 Month 30

1 Formulaires  
Patient Administration
Description

Patient Administration

Alias
UMLS CUI-1
C1320722
Protocol
Description

Protocol

Type de données

integer

Alias
UMLS CUI [1]
C1507394
Center
Description

Center

Type de données

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0805701
Date of Visit
Description

Date of Visit

Type de données

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Description

Subject Number

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
I certify that Informed Consent has been obtained prior to any study procedure.
Description

Informed Consent Date

Type de données

date

Alias
UMLS CUI [1]
C2985782
Demographics
Description

Demographics

Alias
UMLS CUI-1
C0011298
Subject Initials
Description

Subject Initials

Type de données

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Date of birth
Description

Date of birth

Type de données

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Type de données

integer

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Type de données

text

Alias
UMLS CUI [1]
C0034510
Laboratory tests
Description

Laboratory tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken?
Description

Blood sample

Type de données

boolean

Alias
UMLS CUI [1]
C0005834
Vaccination
Description

Vaccination

Alias
UMLS CUI-1
C0042196
Has the subject received since the last visit: A dose of monovalent or combined Hepatitis B vaccine?
Description

Hepatitis B vaccination

Type de données

boolean

Alias
UMLS CUI [1]
C0474232
If 'Yes', please specify:
Description

Hepatitis B vaccination

Type de données

integer

Alias
UMLS CUI [1]
C0474232
A dose of Hepatitis B immunoglobulins within 6 months prior to bleeding?
Description

Hepatitis B immunoglobulins

Type de données

boolean

Alias
UMLS CUI [1]
C0062525
Retour au début de la page

Similar models

Long term follow-up Visit 6 Month 30

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Patient Administration
C1320722 (UMLS CUI-1)
Protocol
Item
Protocol
integer
C1507394 (UMLS CUI [1])
Center
Item
Center
integer
C1301943 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
I certify that Informed Consent has been obtained prior to any study procedure.
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C0011298 (UMLS CUI-1)
Subject Initials
Item
Subject Initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White ((WH))
CL Item
Black ((BL))
CL Item
Oriental ((OR))
CL Item
Other, please specify: ____________________________________________ ((OT))
Item Group
Laboratory tests
C0022885 (UMLS CUI-1)
Blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Item Group
Vaccination
C0042196 (UMLS CUI-1)
Hepatitis B vaccination
Item
Has the subject received since the last visit: A dose of monovalent or combined Hepatitis B vaccine?
boolean
C0474232 (UMLS CUI [1])
Item
If 'Yes', please specify:
integer
C0474232 (UMLS CUI [1])
Hepatitis B vaccination
Code List
If 'Yes', please specify:
CL Item
Monovalent vaccine (1)
CL Item
Combined Hepatitis B vaccine (2)
Hepatitis B immunoglobulins
Item
A dose of Hepatitis B immunoglobulins within 6 months prior to bleeding?
boolean
C0062525 (UMLS CUI [1])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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