ID

24968

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. 8/22/17 8/22/17 -
  2. 8/23/17 8/23/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 23, 2017

DOI

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License

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

English

GSK Hepatitis A Vaccine ADDITIONAL VACCINATION MEDICATION 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
MEDICATION
Description

MEDICATION

Have any of the above mentioned medications/treatments been administered during the period starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after it?
Description

pharmaceutical preparations

Data type

integer

Alias
UMLS CUI [1]
C0013227
MEDICATION
Description

MEDICATION

Trade / Generic Name
Description

pharmaceutical preparations

Data type

text

Alias
UMLS CUI [1]
C0013227
Medical Indication
Description

drug Indication

Data type

boolean

Alias
UMLS CUI [1,1]
C0199176
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0013227
Total daily dose
Description

total daily dose

Data type

text

Alias
UMLS CUI [1]
C2348070
Route
Description

administration route

Data type

text

Alias
UMLS CUI [1]
C0013153
Start Date
Description

Medication Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1521826
UMLS CUI [1,2]
C0808070
End Date
Description

Medication End Date

Data type

date

Alias
UMLS CUI [1,1]
C1521826
UMLS CUI [1,2]
C0806020
Medication Ongoing: check box if continuing at end of Visit 24
Description

Medication Ongoing

Data type

boolean

Alias
UMLS CUI [1]
C2826666
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Similar models

GSK Hepatitis A Vaccine ADDITIONAL VACCINATION MEDICATION 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
MEDICATION
Item
Have any of the above mentioned medications/treatments been administered during the period starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after it?
integer
C0013227 (UMLS CUI [1])
pharmaceutical preparations
Code List
Have any of the above mentioned medications/treatments 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 complete the following table. (2)
Item Group
MEDICATION
pharmaceutical preparations
Item
Trade / Generic Name
text
C0013227 (UMLS CUI [1])
drug Indication
Item
Medical Indication
boolean
C0199176 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1])
Item
Route
text
C0013153 (UMLS CUI [1])
administration route
Code List
Route
CL Item
External (EXT)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intraarticular (IR)
CL Item
Intrathecal (IT)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TO)
CL Item
Unknown (UNK)
CL Item
Vaginal (VA)
Medication Start Date
Item
Start Date
date
C1521826 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication End Date
Item
End Date
date
C1521826 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication Ongoing
Item
Medication Ongoing: check box if continuing at end of Visit 24
boolean
C2826666 (UMLS CUI [1])
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