ID

24860

Descripción

Study ID: 100571 (M138) Clinical Study ID: 100571 Study Title: Double-blind randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 12 month schedule in healthy adult volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A Vaccine, Inactivated Trade Name: Havrix Study Indication: Hepatitis A https://clinicaltrials.gov/ct2/show/NCT00291876

Link

https://clinicaltrials.gov/ct2/show/NCT00291876

Palabras clave

  1. 20/8/17 20/8/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

20 de agosto de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0

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GSK Hepatitis A Vaccine VISIT 23 ADDITIONAL VACCINATION NCT00291876

GSK Hepatitis A Vaccine VISIT 23 ADDITIONAL VACCINATION NCT00291876

Study administration
Descripción

Study administration

Date of Visit
Descripción

Date of Visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Descripción

Subject Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
PRE-VACCINATION ASSESSMENT
Descripción

PRE-VACCINATION ASSESSMENT

Temperature:
Descripción

body temperature

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Route
Descripción

administration route

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013153
LABORATORY TESTS
Descripción

LABORATORY TESTS

Has a blood sample been taken?
Descripción

blood sample

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005834
CMI SAMPLE
Descripción

CMI SAMPLE

Has a blood sample for CMI testing been taken ?
Descripción

CMI SAMPLE

Tipo de datos

integer

Alias
UMLS CUI [1]
C0721837
URINE SAMPLE (Pregnancy test – HCG)
Descripción

URINE SAMPLE (Pregnancy test – HCG)

Has a urine sample been taken?
Descripción

urine sample

Tipo de datos

integer

Alias
UMLS CUI [1]
C0200354

Similar models

GSK Hepatitis A Vaccine VISIT 23 ADDITIONAL VACCINATION NCT00291876

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Study administration
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Subject Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
PRE-VACCINATION ASSESSMENT
body temperature
Item
Temperature:
float
C0005903 (UMLS CUI [1])
Item
Route
integer
C0013153 (UMLS CUI [1])
Code List
Route
CL Item
Oral (recommended) (1)
CL Item
Axillary (recommended) (2)
CL Item
Rectal (3)
CL Item
Not Assessed (4)
Item Group
LABORATORY TESTS
blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Item Group
CMI SAMPLE
Item
Has a blood sample for CMI testing been taken ?
integer
C0721837 (UMLS CUI [1])
Code List
Has a blood sample for CMI testing been taken ?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Item Group
URINE SAMPLE (Pregnancy test – HCG)
Item
Has a urine sample been taken?
integer
C0200354 (UMLS CUI [1])
Code List
Has a urine sample been taken?
CL Item
Yes, results: Negative (1)
CL Item
Yes, results: Positive (2)
CL Item
No (3)
CL Item
NA (4)

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