ID

36417

Description

Study ID: 111258 Clinical Study ID: 111258 Study Title: A phase IV, observer-blind, randomized single-dose post-marketing study to compare the safety and immunogenicity of Fluviral Trivalent Split Virion Influenza Vaccine (2007 - 2008 Season) made with new vs. aged bulk material, in adults ranging in age from 18 to 60 Years. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00586469 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Influenza Vaccine Trade Name: Fluviral Study Indication: Influenza

Keywords

Versions (1)
  1. 5/13/19 5/13/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 13, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Fluvial Trivalent Split Vision Influenza Vaccine; NCT00586469

English

Diary Card - 21 Days After Vaccination

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Day 0 = Date of Vaccination
Description

Vaccination, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0011008
Solicited Adverse Events - Local Symptoms
Description

Solicited Adverse Events - Local Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Local Symptoms
Description

Adverse Event, Symptoms, Local

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Day 0
Description

Adverse Event, Symptoms, Local

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Day 1
Description

Adverse Event, Symptoms, Local

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Day 2
Description

Adverse Event, Symptoms, Local

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Day 3
Description

Adverse Event, Symptoms, Local

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Ongoing after Day 3
Description

Adverse Event, Symptoms, Local, Continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C0549178
Date of last Day of Symptoms
Description

Adverse Event, Symptoms, Local, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C0806020
Medically attended visit
Description

Adverse Event, Symptoms, Local, Visit/Advice

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C0545082
Other Local Symptoms
Description

Other Local Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0205394
Description - please specify side(s) and site(s)
Description

Symptoms, Local, Other

Data type

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0205394
Intensity
Description

Symptoms, Local, Other, Symptom Intensity

Data type

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0518690
Start date
Description

Symptoms, Local, Other, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0808070
End date
Description

Symptoms, Local, Other, End Date

Data type

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0806020
Check box if continuing
Description

Symptoms, Local, Other, Continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0549178
Medically attended Visit?
Description

Symptoms, Local, Other, Visit

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C020539
UMLS CUI [1,4]
C0545082
Medication
Description

Medication

Alias
UMLS CUI-1
C0013227
Trade/Generic name
Description

Pharmaceutical Preparations, Medication name

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2360065
Reason
Description

Pharmaceutical Preparations, Indication

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3146298
Total Daily Dose
Description

Pharmaceutical Preparations, Daily Dose, Total

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0439810
Start date
Description

Pharmaceutical Preparations, Start date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End date
Description

Pharmaceutical Preparations, End date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Check box if continuing
Description

Pharmaceutical Preparations, Continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Solicited Adverse Events - General Symptoms
Description

Solicited Adverse Events - General Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0159028
General Symptoms
Description

Adverse Event, General symptom

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 0
Description

Adverse Event, General symptom

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 1
Description

Adverse Event, General symptom

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 2
Description

Adverse Event, General symptom

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 3
Description

Adverse Event, General symptom

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Ongoing after Day 3
Description

Adverse Event, General symptom, Continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0549178
Date of last Day of Symptoms
Description

Adverse Event, General symptom, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0806020
Medically attended visit
Description

Adverse Event, General symptom, Visit/Advice

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0545082
Other General Symptoms
Description

Other General Symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0205394
Description - please specify side(s) and site(s)
Description

General symptom, Other

Data type

text

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0205394
Intensity
Description

General symptom, Other, Symptom Intensity

Data type

text

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0518690
Start date
Description

General symptom, Other, Start date

Data type

date

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0808070
End date
Description

General symptom, Other, End date

Data type

date

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0806020
Check box if continuing
Description

General symptom, Other, Continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0549178
Medically attended Visit?
Description

General symptom, Other, Visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0545082
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Similar models

Diary Card - 21 Days After Vaccination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Vaccination, Date in time
Item
Day 0 = Date of Vaccination
date
C0042196 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Solicited Adverse Events - Local Symptoms
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Item
Local Symptoms
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Adverse Event, Symptoms, Local
Item
Day 0
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Item
Day 1
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Item
Day 2
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Item
Day 3
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after Day 3
boolean
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Adverse Event, Symptoms, Local, End Date
Item
Date of last Day of Symptoms
date
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Adverse Event, Symptoms, Local, Visit/Advice
Item
Medically attended visit
boolean
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
Item Group
Other Local Symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Symptoms, Local, Other
Item
Description - please specify side(s) and site(s)
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Symptoms, Local, Other, Symptom Intensity
Item
Intensity
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,4])
Symptoms, Local, Other, Start Date
Item
Start date
date
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
Symptoms, Local, Other, End Date
Item
End date
date
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Symptoms, Local, Other, Continuous
Item
Check box if continuing
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Symptoms, Local, Other, Visit
Item
Medically attended Visit?
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C020539 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
Item Group
Medication
C0013227 (UMLS CUI-1)
Pharmaceutical Preparations, Medication name
Item
Trade/Generic name
text
C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Pharmaceutical Preparations, Indication
Item
Reason
text
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Pharmaceutical Preparations, Daily Dose, Total
Item
Total Daily Dose
text
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Pharmaceutical Preparations, Start date
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Pharmaceutical Preparations, End date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Pharmaceutical Preparations, Continuous
Item
Check box if continuing
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
Solicited Adverse Events - General Symptoms
C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
Item
General Symptoms
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, Symptoms, Local
Code List
General Symptoms
CL Item
Fever, give °C (1)
CL Item
Fever: Oral (Mandatory) (2)
CL Item
Fatigue, give intensity (3)
CL Item
Headache, give intensity (4)
CL Item
Muscle pain, give intensity (5)
CL Item
Chills, give intensity (6)
CL Item
Red eyes, give intensity (7)
CL Item
Joint pain, give intensity (8)
CL Item
Swelling of the face, give intensity (9)
CL Item
Cough, give intensity (10)
CL Item
Chest tightness or difficulty in breathing, give intensity (11)
CL Item
Sore throat or hoarseness or pain on swallowing, give intensity (12)
Adverse Event, General symptom
Item
Day 0
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 1
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 2
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 3
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom, Continuous
Item
Ongoing after Day 3
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Adverse Event, General symptom, End Date
Item
Date of last Day of Symptoms
date
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Adverse Event, General symptom, Visit/Advice
Item
Medically attended visit
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Item Group
Other General Symptoms
C0159028 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
General symptom, Other
Item
Description - please specify side(s) and site(s)
text
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
General symptom, Other, Symptom Intensity
Item
Intensity
text
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
General symptom, Other, Start date
Item
Start date
date
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
General symptom, Other, End date
Item
End date
date
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
General symptom, Other, Continuous
Item
Check box if continuing
boolean
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
General symptom, Other, Visit
Item
Medically attended Visit?
boolean
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
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