ID

24861

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. 8/20/17 8/20/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 20, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK Hepatitis A Vaccine VISIT 23 ADDITIONAL VACCINATION VACCINE ADMINISTRATION NCT00291876

English

GSK Hepatitis A Vaccine VISIT 23 ADDITIONAL VACCINATION VACCINE ADMINISTRATION NCT00291876

1 forms  
Study administration
Description

Study administration

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
VACCINE ADMINISTRATION
Description

VACCINE ADMINISTRATION

VACCINE ADMINISTRATION (only one box must be checked)
Description

VACCINE ADMINISTRATION

Data type

integer

Alias
UMLS CUI [1]
C2368628
(*) Comments:
Description

VACCINE ADMINISTRATION

Data type

text

Alias
UMLS CUI [1]
C2368628
Has the study vaccine been administered according to the protocol?
Description

VACCINE ADMINISTRATION

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
Side
Description

VACCINE ADMINISTRATION side

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
Site
Description

VACCINE ADMINISTRATION site

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
Site
Description

administration site

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Route
Description

administration route

Data type

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
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Similar models

GSK Hepatitis A Vaccine VISIT 23 ADDITIONAL VACCINATION VACCINE ADMINISTRATION NCT00291876

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
VACCINE ADMINISTRATION
Item
VACCINE ADMINISTRATION (only one box must be checked)
integer
C2368628 (UMLS CUI [1])
VACCINE ADMINISTRATION
Code List
VACCINE ADMINISTRATION (only one box must be checked)
CL Item
HAVRIX™ Vaccine (1)
CL Item
Not administered (*) (2)
VACCINE ADMINISTRATION
Item
(*) Comments:
text
C2368628 (UMLS CUI [1])
Item
Has the study vaccine been administered according to the protocol?
integer
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
VACCINE ADMINISTRATION
Code List
Has the study vaccine been administered according to the protocol?
CL Item
Yes (1)
CL Item
No -> please check all items (2)
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
VACCINE ADMINISTRATION
Code List
Side
CL Item
Non-dominant arm (1)
CL Item
Dominant arm (2)
Item
Site
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
VACCINE ADMINISTRATION
Code List
Site
CL Item
Non-dominant arm (1)
CL Item
Dominant arm (2)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
administration site
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
administration route
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
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