ID

25901

Descripción

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

Palabras clave

Versiones (2)
  1. 23/8/17 23/8/17 -
  2. 26/9/17 26/9/17 -
Subido en

26 de septiembre de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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GSK Hepatitis A Vaccine ADDITIONAL VACCINATION CONCOMITANT VACCINATION NCT00291876

Inglés

GSK Hepatitis A Vaccine ADDITIONAL VACCINATION CONCOMITANT VACCINATION NCT00291876

1 formularios  
Study administration
Descripción

Study administration

Center
Descripción

Center

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1301943 (Institution name)
SNOMED
398321007
UMLS CUI [1,2]
C0600091 (Identifier)
SNOMED
118522005
LOINC
LP31795-5
Date of Visit
Descripción

Date of Visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303 (Date of visit)
SNOMED
406543005
Subject Number
Descripción

Subject Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
CONCOMITANT VACCINATION
Descripción

CONCOMITANT VACCINATION

Has any vaccine other than the study vaccine(s) been administered during the period starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after it?
Descripción

Concomitant Vaccination

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0042196 (Vaccination)
SNOMED
33879002
LOINC
LP29692-8
UMLS CUI [1,2]
C2347852 (Concomitant Agent)
Administration date
Descripción

admnistration date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1533734 (Administration procedure)
SNOMED
416118004
LOINC
LA20296-2
UMLS CUI [1,2]
C0011008 (Date in time)
SNOMED
410671006
UMLS CUI [1,3]
C0042210 (Vaccines)
SNOMED
787859002
LOINC
LA20283-0
CONCOMITANT VACCINATION
Descripción

CONCOMITANT VACCINATION

Trade / Generic Name
Descripción

vaccine

Tipo de datos

text

Alias
UMLS CUI [1]
C0042210 (Vaccines)
SNOMED
787859002
LOINC
LA20283-0
For GSK
Descripción

comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611 (Comment)
LOINC
LP72293-1
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Similar models

GSK Hepatitis A Vaccine ADDITIONAL VACCINATION CONCOMITANT VACCINATION NCT00291876

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
CONCOMITANT VACCINATION
Item
Has any vaccine other than the study vaccine(s) been administered during the period starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after it?
text
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
pharmaceutical preparations
Code List
Has any vaccine other than the study vaccine(s) been administered during the period starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after it?
CL Item
No (1)
CL Item
Yes, please record concomitant vaccination with trade name and/or generic name, route and vaccine administration date (fill in items below). (2)
admnistration date
Item
Administration date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item Group
CONCOMITANT VACCINATION
vaccine
Item
Trade / Generic Name
text
C0042210 (UMLS CUI [1])
comment
Item
For GSK
text
C0947611 (UMLS CUI [1])
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