ID

25901

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 (2)
  1. 8/23/17 8/23/17 -
  2. 9/26/17 9/26/17 -
Uploaded on

September 26, 2017

DOI

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License

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

English

GSK Hepatitis A Vaccine ADDITIONAL VACCINATION CONCOMITANT VACCINATION 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
CONCOMITANT VACCINATION
Description

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?
Description

Concomitant Vaccination

Data type

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Administration date
Description

admnistration date

Data type

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0042210
CONCOMITANT VACCINATION
Description

CONCOMITANT VACCINATION

Trade / Generic Name
Description

vaccine

Data type

text

Alias
UMLS CUI [1]
C0042210
For GSK
Description

comment

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

GSK Hepatitis A Vaccine ADDITIONAL VACCINATION CONCOMITANT VACCINATION 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
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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