ID

24894

Descrição

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

Palavras-chave

  1. 22/08/2017 22/08/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

22 de agosto de 2017

DOI

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Licença

Creative Commons BY-NC 3.0

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GSK Hepatitis A Vaccine Month 162 VISIT 20 LABORATORY TESTS NCT00291876

GSK Hepatitis A Vaccine Month 162 VISIT 20 LABORATORY TESTS NCT00291876

Study administration
Descrição

Study administration

Center
Descrição

Center

Tipo de dados

text

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

Date of Visit

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Descrição

Subject Identifier

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
BLOOD SAMPLE
Descrição

BLOOD SAMPLE

Has a blood sample been taken for serology?
Descrição

blood sample

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005834
Has the subject received a dose of Hepatitis A immunoglobulins within 6 months prior to bleeding ?
Descrição

Hepatitis A immunoglobulins

Tipo de dados

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?
Descrição

monovalent or combined Hepatitis A vaccine

Tipo de dados

integer

Alias
UMLS CUI [1]
C3652495
Did the subject suffer from Hepatitis A since last visit?
Descrição

Hepatitis A

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019159

Similar models

GSK Hepatitis A Vaccine Month 162 VISIT 20 LABORATORY TESTS NCT00291876

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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
BLOOD SAMPLE
blood sample
Item
Has a blood sample been taken for serology?
boolean
C0005834 (UMLS CUI [1])
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])
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)
Hepatitis A
Item
Did the subject suffer from Hepatitis A since last visit?
boolean
C0019159 (UMLS CUI [1])

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