ID

24898

Description

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

Keywords

Versions (1)
  1. 8/22/17 8/22/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 22, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK Hepatitis A Vaccine Month 186 VISIT 22 LABORATORY TESTS NCT00291876

English

GSK Hepatitis A Vaccine Month 186 VISIT 22 LABORATORY TESTS NCT00291876

1 forms  
Study administration
Description

Study administration

Center
Description

Center

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
BLOOD SAMPLE
Description

BLOOD SAMPLE

Has a blood sample been taken for serology?
Description

blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Has the subject received since the last visit: A dose of monovalent or combined Hepatitis A vaccine?
Description

monovalent or combined Hepatitis A vaccine

Data type

boolean

Alias
UMLS CUI [1]
C3652495
A dose of Hepatitis A immunoglobulins within 6 months prior to bleeding?
Description

Hepatitis A immunoglobulins

Data type

boolean

Alias
UMLS CUI [1,1]
C3652495
UMLS CUI [1,2]
C0019080
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Similar models

GSK Hepatitis A Vaccine Month 186 VISIT 22 LABORATORY TESTS NCT00291876

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study administration
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Subject Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
BLOOD SAMPLE
blood sample
Item
Has a blood sample been taken for serology?
boolean
C0005834 (UMLS CUI [1])
monovalent or combined Hepatitis A vaccine
Item
Has the subject received since the last visit: A dose of monovalent or combined Hepatitis A vaccine?
boolean
C3652495 (UMLS CUI [1])
Hepatitis A immunoglobulins
Item
A dose of Hepatitis A immunoglobulins within 6 months prior to bleeding?
boolean
C3652495 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
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