ID

33875

Description

Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Keywords

  1. 1/5/19 1/5/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 5, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B

Medication

  1. StudyEvent: ODM
    1. Medication
Medication
Description

Medication

Alias
UMLS CUI-1
C0013227
Have any of the above mentioned medications/treatments been administered during the study period?
Description

Pharmaceutical Preparations, During, Study

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2603343
Trade / Generic Name
Description

Medication Name

Data type

text

Alias
UMLS CUI [1]
C2360065
Medical Indication
Description

Pharmaceutical Preparations, Indication

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3146298
Medical Indication: Prophylactic
Description

Pharmaceutical Preparations, Indication, Prophylactic treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0199176
Total daily dose
Description

Pharmaceutical Preparations, Daily Dose

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348070
Route
Description

Pharmaceutical Preparations, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0013153
Start Date
Description

Pharmaceutical Preparations, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date
Description

Pharmaceutical Preparations, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Continuing at end of study
Description

Pharmaceutical Preparations, Continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178

Similar models

Medication

  1. StudyEvent: ODM
    1. Medication
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Medication
C0013227 (UMLS CUI-1)
Pharmaceutical Preparations, During, Study
Item
Have any of the above mentioned medications/treatments been administered during the study period?
boolean
C0013227 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
Medication Name
Item
Trade / Generic Name
text
C2360065 (UMLS CUI [1])
Pharmaceutical Preparations, Indication
Item
Medical Indication
text
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Pharmaceutical Preparations, Indication, Prophylactic treatment
Item
Medical Indication: Prophylactic
boolean
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0199176 (UMLS CUI [1,3])
Pharmaceutical Preparations, Daily Dose
Item
Total daily dose
text
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
Pharmaceutical Preparations, Drug Administration Routes
Item
Route
text
C0013227 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Pharmaceutical Preparations, Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Pharmaceutical Preparations, End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Pharmaceutical Preparations, Continuous
Item
Continuing at end of study
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])

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