ID

36112

Description

Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Keywords

Versions (1)
  1. 4/15/19 4/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 15, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718

English

Long-Term Follow Up (Year 15; Additional Vaccination) - Concomitant Vaccination; Medication; Non-Serious Adverse Experiences

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Concomitant Vaccination
Description

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has any vaccine other than the study vaccine(s) been administered one starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after the vaccine dose?
Description

If Yes, please record concomitant vaccination with trade name and/or generic name, route and vaccine administration date

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Concomitant Vaccination
Description

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Trade Name/ (Generic) Name
Description

Trade Name/ (Generic) Name

Data type

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0592502
Administration Route
Description

Administration Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Administration Date
Description

Administration Date

Data type

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
Medication
Description

Medication

Alias
UMLS CUI-1
C0013227
Have any medications/treatments been administered starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after the vaccine dose?
Description

If Yes, please complete the following table.

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2347852
Medication
Description

Medication

Alias
UMLS CUI-1
C0013227
Trade/ Generic Name
Description

Trade/ Generic Name

Data type

text

Alias
UMLS CUI [1]
C2360065
Medical Indication
Description

Medical Indication

Data type

integer

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

Total daily dose

Data type

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0439810
Administration Route
Description

Administration Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Medication Start Date
Description

Medication Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Medication End Date
Description

Medication End Date

Data type

date

Alias
UMLS CUI [1]
C2826744
Tick box if continuing at end of study
Description

Tick box if continuing at end of study

Data type

integer

Alias
UMLS CUI [1,1]
C1553904
UMLS CUI [1,2]
C2983670
Non-Serious Adverse Events
Description

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Description

If Yes, please complete the following table

Data type

boolean

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2,1]
C0687676
UMLS CUI [2,2]
C0042196
Non-Serious Adverse Events
Description

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
AE No
Description

AE No

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Non-Serious Adverse Event Description
Description

Non-Serious Adverse Event Description

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
Non-Serious Adverse Event location
Description

Non-Serious Adverse Event location

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0450429
Date Non-Serious Adverse Event Started
Description

Date Non-Serious Adverse Event Started

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Non-Serious Adverse Event Start Date during immediate post-vaccination period (30 minutes)
Description

Non-Serious Adverse Event Start Date during immediate post-vaccination period (30 minutes)

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0687676
UMLS CUI [1,5]
C0205253
Date Non-Serious Adverse Event Stopped
Description

Date Non-Serious Adverse Event Stopped

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Non-Serious Adverse Event Intensity
Description

Non-Serious Adverse Event Intensity

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1710066
Relationship to investigational products:
Description

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Non-Serious Adverse Event Outcome
Description

Non-Serious Adverse Event Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Back to the top of the page

Similar models

Long-Term Follow Up (Year 15; Additional Vaccination) - Concomitant Vaccination; Medication; Non-Serious Adverse Experiences

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Has any vaccine other than the study vaccine(s) been administered one starting 30 days prior to the vaccine dose and ending one month after the vaccine dose?
Item
Has any vaccine other than the study vaccine(s) been administered one starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after the vaccine dose?
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Trade Name/ (Generic) Name
Item
Trade Name/ (Generic) Name
text
C2360065 (UMLS CUI [1,1])
C0592502 (UMLS CUI [1,2])
Item
Administration Route
text
C0013153 (UMLS CUI [1])
Administration Route
Code List
Administration 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)
Administration Date
Item
Administration Date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Medication
C0013227 (UMLS CUI-1)
Have any medications/treatments been administered starting 30 days prior to the vaccine dose and ending one month after the vaccine dose?
Item
Have any medications/treatments been administered starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after the vaccine dose?
boolean
C0013227 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item Group
Medication
C0013227 (UMLS CUI-1)
Trade/ Generic Name
Item
Trade/ Generic Name
text
C2360065 (UMLS CUI [1])
Item
Medical Indication
integer
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical Indication
Code List
Medical Indication
CL Item
Prophylactic (1)
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Administration Route
Item
Administration Route
text
C0013153 (UMLS CUI [1])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication End Date
Item
Medication End Date
date
C2826744 (UMLS CUI [1])
Item
Tick box if continuing at end of study
integer
C1553904 (UMLS CUI [1,1])
C2983670 (UMLS CUI [1,2])
Tick box if continuing at end of study
Code List
Tick box if continuing at end of study
CL Item
Continuing at end of study (1)
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Has any non-serious adverse events occurred within one month post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
C1518404 (UMLS CUI [1])
C0687676 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
AE No
Item
AE No
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-Serious Adverse Event Description
Item
Non-Serious Adverse Event Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event location
text
C1518404 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Non-Serious Adverse Experiences location
Code List
Non-Serious Adverse Event location
CL Item
Administration site (L)
CL Item
Non-administration site (G)
Date Non-Serious Adverse Event Started
Item
Date Non-Serious Adverse Event Started
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Start Date during immediate post-vaccination period (30 minutes)
integer
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0205253 (UMLS CUI [1,5])
Start Date during immediate post-vaccination period specified in protocol
Code List
Non-Serious Adverse Event Start Date during immediate post-vaccination period (30 minutes)
CL Item
Start Date during immediate post-vaccination period (30 minutes) (1)
Date Non-Serious Adverse Event Stopped
Item
Date Non-Serious Adverse Event Stopped
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Intensity
integer
C1518404 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Intensity
Code List
Non-Serious Adverse Event Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Relationship to investigational products:
Item
Relationship to investigational products:
boolean
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item
Non-Serious Adverse Event Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-Serious Adverse Experience Outcome
Code List
Non-Serious Adverse Event Outcome
CL Item
Recovered/ Resolved (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ not resolved (3)
CL Item
Recovered with sequelae/ Resolved with sequelae (4)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial