ID

33875

Descripción

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

Palabras clave

  1. 5/1/19 5/1/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

5 de enero de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0

Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

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

  1. StudyEvent: ODM
    1. Medication
Medication
Descripción

Medication

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

Pharmaceutical Preparations, During, Study

Tipo de datos

boolean

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

Medication Name

Tipo de datos

text

Alias
UMLS CUI [1]
C2360065
Medical Indication
Descripción

Pharmaceutical Preparations, Indication

Tipo de datos

text

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

Pharmaceutical Preparations, Indication, Prophylactic treatment

Tipo de datos

boolean

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

Pharmaceutical Preparations, Daily Dose

Tipo de datos

text

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

Pharmaceutical Preparations, Drug Administration Routes

Tipo de datos

text

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

Pharmaceutical Preparations, Start Date

Tipo de datos

date

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

Pharmaceutical Preparations, End Date

Tipo de datos

date

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

Pharmaceutical Preparations, Continuous

Tipo de datos

boolean

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

Similar models

Medication

  1. StudyEvent: ODM
    1. Medication
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

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