ID

24902

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 174 Visit 21 DEMOGRAPHICS NCT00291876

English

GSK Hepatitis A Vaccine Month 174 Visit 21 DEMOGRAPHICS 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
DEMOGRAPHICS
Description

DEMOGRAPHICS

I certify that Informed Consent has been obtained prior to any study procedure. Informed Consent Date:
Description

Informed Consent Date

Data type

date

Alias
UMLS CUI [1]
C2985782
Subject Initials
Description

Subject Initials

Data type

text

Measurement units
  • _ _ First Name / _ _ Family Name
Alias
UMLS CUI [1]
C2986440
_ _ First Name / _ _ Family Name
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
If Other, please specify
Description

other Race

Data type

text

Alias
UMLS CUI [1]
C0034510
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Similar models

GSK Hepatitis A Vaccine Month 174 Visit 21 DEMOGRAPHICS 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
DEMOGRAPHICS
Informed Consent Date
Item
I certify that Informed Consent has been obtained prior to any study procedure. Informed Consent Date:
date
C2985782 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White (WH)
CL Item
Black (BL)
CL Item
Oriental (OR)
CL Item
Other, please specify (OT)
other Race
Item
If Other, please specify
text
C0034510 (UMLS CUI [1])
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