ID

24162

Description

Study ID: 100576 (Y11) Clinical Study ID: 100576 Study Title: Double-blind, randomized study to evaluate the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 6 month schedule in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289757 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 Documentation part: Visit 16, Long term Follow-up, 132 months +/- 2 months (Year 11)

Keywords

Versions (1)
  1. 7/27/17 7/27/17 -
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July 27, 2017

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License

Creative Commons BY-NC 3.0
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Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine Visit 16 100576

English

Visit 16 Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 100576

1 forms  
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C0170300
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Center number
Description

Center number

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
Informed Consent Date
Description

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

Data type

time

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Demographics
Description

Demographics

Alias
UMLS CUI-1
C0011298
UMLS CUI-2
C0170300
Subject Initials
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
Race, if other please specify
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
Laboratory Tests
Description

Laboratory Tests

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005834
UMLS CUI-3
C0170300
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

Hepatitis A vaccine

Data type

boolean

Alias
UMLS CUI [1]
C0170300
Has the subject received since the last visit: A dose of Hepatitis A immunoglobulins within 6 months prior to bleeding?
Description

Hepatitis A immunoglobulins

Data type

boolean

Alias
UMLS CUI [1]
C3652495
Follow-up Studies
Description

Follow-up Studies

Alias
UMLS CUI-1
C0016441
UMLS CUI-2
C0170300
Would the subject be willing to participate in a follow-up study?
Description

follow-up study

Data type

boolean

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
reason for non participation
Description

If No, please specify the reason

Data type

integer

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Reason for non participation: Adverse Events, or Serious Adverse Events, please specify
Description

reason for non participation

Data type

text

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2,1]
C0558080
UMLS CUI [2,2]
C0679823
UMLS CUI [2,3]
C0392360
Reason for non participation: Other, please specify
Description

reason for non participation

Data type

text

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Investigator Signature
Description

I certify that I have reviewed the data in this case report form, and the Serious Adverse Event section (if applicable) and that all information is complete and accurate.

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Visit 16 Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 100576

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
C0170300 (UMLS CUI-2)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Informed Consent Date
Item
Informed Consent Date
time
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Demographics
C0011298 (UMLS CUI-1)
C0170300 (UMLS CUI-2)
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
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 (OT)
Race
Item
Race, if other please specify
text
C0034510 (UMLS CUI [1])
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0170300 (UMLS CUI-3)
blood sample
Item
Has a blood sample been taken for serology?
boolean
C0005834 (UMLS CUI [1])
Hepatitis A vaccine
Item
Has the subject received since the last visit: A dose of monovalent or combined Hepatitis A vaccine?
boolean
C0170300 (UMLS CUI [1])
Hepatitis A immunoglobulins
Item
Has the subject received since the last visit: A dose of Hepatitis A immunoglobulins within 6 months prior to bleeding?
boolean
C3652495 (UMLS CUI [1])
Item Group
Follow-up Studies
C0016441 (UMLS CUI-1)
C0170300 (UMLS CUI-2)
follow-up study
Item
Would the subject be willing to participate in a follow-up study?
boolean
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Item
reason for non participation
integer
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
reason for non participation
Code List
reason for non participation
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Other (2)
reason for non participation
Item
Reason for non participation: Adverse Events, or Serious Adverse Events, please specify
text
C0877248 (UMLS CUI [1])
C0558080 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C0392360 (UMLS CUI [2,3])
reason for non participation
Item
Reason for non participation: Other, please specify
text
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
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