ID

24860

Beschrijving

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

Trefwoorden

  1. 20-08-17 20-08-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

20 augustus 2017

DOI

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Licentie

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
Beschrijving

Study administration

Date of Visit
Beschrijving

Date of Visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Beschrijving

Subject Identifier

Datatype

integer

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

PRE-VACCINATION ASSESSMENT

Temperature:
Beschrijving

body temperature

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Route
Beschrijving

administration route

Datatype

integer

Alias
UMLS CUI [1]
C0013153
LABORATORY TESTS
Beschrijving

LABORATORY TESTS

Has a blood sample been taken?
Beschrijving

blood sample

Datatype

boolean

Alias
UMLS CUI [1]
C0005834
CMI SAMPLE
Beschrijving

CMI SAMPLE

Has a blood sample for CMI testing been taken ?
Beschrijving

CMI SAMPLE

Datatype

integer

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

URINE SAMPLE (Pregnancy test – HCG)

Has a urine sample been taken?
Beschrijving

urine sample

Datatype

integer

Alias
UMLS CUI [1]
C0200354

Similar models

GSK Hepatitis A Vaccine VISIT 23 ADDITIONAL VACCINATION NCT00291876

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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