ID

38315

Descripción

Study ID: 103860/277 Clinical Study ID: 103860/277 Study Title: Phase III study of immunogenicity and safety of 3 doses of GSK Biologicals' thimerosal-free hepatitis B vaccine compared to the US-licensed GSK Biologicals' preservative-free hepatitis B vaccine when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

Palabras clave

Versiones (2)
  1. 8/10/19 8/10/19 -
  2. 9/10/19 9/10/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

9 de octubre de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Immunogenicity and safety of hepatitis B vaccine when administered intramuscularly to healthy infants in their first two weeks of life (103860/277)

Inglés

Visit 2 - Pre-Vaccination Assessment

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Date of visit
Descripción

Date of visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Subject number
Descripción

Subject number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Pre-Vaccination Assessment
Descripción

Pre-Vaccination Assessment

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0220825
UMLS CUI-3
C0332152
Pre-Vaccination Temperature
Descripción

Pre-Vaccination Temperature

Tipo de datos

float

Unidades de medida
  • °F
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
°F
Temperature Route
Descripción

Temperature Route

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0449687
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Similar models

Visit 2 - Pre-Vaccination Assessment

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Pre-Vaccination Assessment
C0042196 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
Pre-Vaccination Temperature
Item
Pre-Vaccination Temperature
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Temperature Route
integer
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
Temperature Route
Code List
Temperature Route
CL Item
Rectal (1)
CL Item
Axillary (2)
CL Item
Tympanic oral (3)
CL Item
Tympanic rectal (4)
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