ID

24859

Beschreibung

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

Stichworte

Versionen (1)
  1. 20.08.17 20.08.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. August 2017

DOI

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Lizenz

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

Englisch

GSK Hepatitis A Vaccine Month 186 VISIT 22 LABORATORY TESTS NCT00291876

1 Formulare  
Study administration
Beschreibung

Study administration

Center
Beschreibung

Center

Datentyp

text

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

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Beschreibung

Subject Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
LABORATORY TESTS
Beschreibung

LABORATORY TESTS

Has a blood sample been taken for serology?
Beschreibung

blood sample

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
VACCINE HISTORY
Beschreibung

VACCINE HISTORY

Has the subject received a dose of Hepatitis A immunoglobulins within 6 months prior to bleeding ?
Beschreibung

Hepatitis A immunoglobulins

Datentyp

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?
Beschreibung

monovalent or combined Hepatitis A vaccine

Datentyp

integer

Alias
UMLS CUI [1]
C3652495
DISEASE HISTORY
Beschreibung

DISEASE HISTORY

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

Hepatitis A

Datentyp

boolean

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

AGREEMENT FOR BOOSTER VACCINATION

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

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.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0940824
UMLS CUI [1,3]
C1511481
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Ähnliche Modelle

GSK Hepatitis A Vaccine Month 186 VISIT 22 LABORATORY TESTS NCT00291876

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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