ID

24859

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 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
LABORATORY TESTS
Description

LABORATORY TESTS

Has a blood sample been taken for serology?
Description

blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
VACCINE HISTORY
Description

VACCINE HISTORY

Has the subject received 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
Has the subject received a dose of monovalent or combined Hepatitis A vaccine since last visit?
Description

monovalent or combined Hepatitis A vaccine

Data type

integer

Alias
UMLS CUI [1]
C3652495
DISEASE HISTORY
Description

DISEASE HISTORY

Did the subject suffer from Hepatitis A since last visit?
Description

Hepatitis A

Data type

boolean

Alias
UMLS CUI [1]
C0019159
AGREEMENT FOR BOOSTER VACCINATION
Description

AGREEMENT FOR BOOSTER VACCINATION

If the subject fulfills criteria for booster administration, does he agree to receive an additional vaccination?
Description

If Yes, the subject will receive Havrix™. Please complete the entire CRF. If No, please complete the SAE section and the study conclusion section only.

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0940824
UMLS CUI [1,3]
C1511481
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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
LABORATORY TESTS
blood sample
Item
Has a blood sample been taken for serology?
boolean
C0005834 (UMLS CUI [1])
Item Group
VACCINE HISTORY
Hepatitis A immunoglobulins
Item
Has the subject received a dose of Hepatitis A immunoglobulins within 6 months prior to bleeding ?
boolean
C3652495 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
Item
Has the subject received a dose of monovalent or combined Hepatitis A vaccine since last visit?
integer
C3652495 (UMLS CUI [1])
monovalent or combined Hepatitis A vaccine
Code List
Has the subject received a dose of monovalent or combined Hepatitis A vaccine since last visit?
CL Item
Yes Hepatitis A vaccine (1)
CL Item
Yes Combined Hepatitis A containing vaccine (2)
CL Item
No (3)
Item Group
DISEASE HISTORY
Hepatitis A
Item
Did the subject suffer from Hepatitis A since last visit?
boolean
C0019159 (UMLS CUI [1])
Item Group
AGREEMENT FOR BOOSTER VACCINATION
additional vaccination agreement
Item
If the subject fulfills criteria for booster administration, does he agree to receive an additional vaccination?
boolean
C0042196 (UMLS CUI [1,1])
C0940824 (UMLS CUI [1,2])
C1511481 (UMLS CUI [1,3])
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