ID

35182

Beschreibung

Study ID: 107022 Clinical Study ID: 107022 Study Title: A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00321373 Study Link: https://clinicaltrials.gov/ct2/show/NCT00321373 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Trade Name: FluarixTM Study Indication: Influenza The purpose of this document is to serve as a diary card for the subject. It should be filled out all through the study. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1

Link

https://clinicaltrials.gov/ct2/show/NCT00321373

Stichworte

Versionen (3)
  1. 12.02.19 12.02.19 -
  2. 16.02.19 16.02.19 -
  3. 22.02.19 22.02.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

22. Februar 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373

Englisch

Diary Card

1 Formulare  
  1. StudyEvent: ODM
    1. Diary Card
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Day of Vaccination
Beschreibung

Day 0

Datentyp

date

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

Solicited Adverse Events Record - Local Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0042196
Local Symptom
Beschreibung

for each symptom, every item hereafter should be ticked accordingly.

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Study Day
Beschreibung

Fill out for each day

Datentyp

integer

Alias
UMLS CUI [1]
C2826182
Intensity
Beschreibung

Intensity: Pain (at injection site): 0:Absent. 1:Painful on touch. 2:Painful when limb is moved. 3:Spontaneously painful / prevents normal activity.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0030193
Size
Beschreibung

Please measure the greatest diameter (in mm), for redness, swelling or ecchymosis

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1]
C0449453
mm
Ongoing after Day 6?
Beschreibung

Ongoing Symptom

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of Last Day of Symptoms
Beschreibung

if ongoing after Day 6

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Other Local Symptoms (Day 0 to Day 29)
Beschreibung

Other Local Symptoms (Day 0 to Day 29)

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0042196
Description
Beschreibung

please specify side(s) and site(s

Datentyp

text

Alias
UMLS CUI [1]
C0678257
Intensity
Beschreibung

Other local symptoms: 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities. (In adults/ adolescents, such an adverse would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy).

Datentyp

integer

Alias
UMLS CUI [1]
C0518690
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
End Date
Beschreibung

if symptom ended during the study period

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Ongoing Symptom
Beschreibung

tick if symptom has not ended during the study period

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Medication
Beschreibung

Medication

Alias
UMLS CUI-1
C2347852
Trade/Generic Name
Beschreibung

Trade/Generic Name

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Reason
Beschreibung

Reason

Datentyp

text

Alias
UMLS CUI [1]
C0392360
Total Daily Dose
Beschreibung

Total Daily Dose

Datentyp

text

Alias
UMLS CUI [1]
C2348070
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
End Date
Beschreibung

tick if medication has ended during the study period

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication
Beschreibung

tick if medication has not ended during the study period

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
Solicited Adverse Events Record - General Symptoms
Beschreibung

Solicited Adverse Events Record - General Symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
General Symptom
Beschreibung

arthralgia = joint pain for each symptom, every item hereafter should be ticked accordingly.

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C1556354
Study Day
Beschreibung

Fill out for each day

Datentyp

integer

Alias
UMLS CUI [1]
C2826182
Intensity
Beschreibung

Fatigue, Headache, Muscle Ache, Shivering, Arthralgia/Joint Pain 0: Normal 1: Easily tolerated 2: Interferes with normal activity 3: That prevents normal activity

Datentyp

integer

Alias
UMLS CUI [1]
C0518690
Ongoing after Day 6?
Beschreibung

Ongoing Symptom

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of Last Day of Symptoms
Beschreibung

Date of Last Day of Symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Solicited Adverse Events - Temperature
Beschreibung

Solicited Adverse Events - Temperature

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
UMLS CUI-4
C0039476
Temperature Measurement Route
Beschreibung

oral is preferred

Datentyp

text

Alias
UMLS CUI [1]
C0886414
Study Day
Beschreibung

Fill out for each day

Datentyp

integer

Alias
UMLS CUI [1]
C2826182
Body Temperature
Beschreibung

Body Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Ongoing after Day 6?
Beschreibung

Ongoing Symptom

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of Last Day of Symptoms
Beschreibung

Date of Last Day of Symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Other General Symptoms (Day 0 to Day 29)
Beschreibung

Other General Symptoms (Day 0 to Day 29)

Alias
UMLS CUI-1
C0029625
Description
Beschreibung

please specify side(s) and site(s

Datentyp

text

Alias
UMLS CUI [1]
C0678257
Intensity
Beschreibung

Other general symptoms: 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities. (In adults/ adolescents, such an adverse would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy).

Datentyp

integer

Alias
UMLS CUI [1]
C0518690
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
End Date
Beschreibung

tick if symptom has ended during the study period

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Ongoing Symptom
Beschreibung

tick if symptom has not ended during the study period

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
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Ähnliche Modelle

Diary Card

1 Formulare
  1. StudyEvent: ODM
    1. Diary Card
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Day of Vaccination
Item
Day of Vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item Group
Solicited Adverse Events Record - Local Symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Item
Local Symptom
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local Symptom
Code List
Local Symptom
CL Item
Redness (RE)
CL Item
Swelling (SW)
CL Item
Ecchymosis (EC)
CL Item
Pain (PA)
Item
Study Day
integer
C2826182 (UMLS CUI [1])
Study Day
Code List
Study Day
CL Item
Day 0 (0)
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
Item
Intensity
integer
C0518690 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Intensity
Code List
Intensity
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Size
Item
Size
integer
C0449453 (UMLS CUI [1])
Ongoing Symptom
Item
Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Date of Last Day of Symptoms
Item
Date of Last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
Other Local Symptoms (Day 0 to Day 29)
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Description
Item
Description
text
C0678257 (UMLS CUI [1])
Item
Intensity
integer
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Ongoing Symptom
Item
Ongoing Symptom
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Item Group
Medication
C2347852 (UMLS CUI-1)
Trade/Generic Name
Item
Trade/Generic Name
text
C2360065 (UMLS CUI [1])
Reason
Item
Reason
text
C0392360 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Ongoing Medication
Item
Ongoing Medication
boolean
C2826666 (UMLS CUI [1])
Item Group
Solicited Adverse Events Record - General Symptoms
C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
General Symptom
text
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C1556354 (UMLS CUI [1,3])
General Symptom
Code List
General Symptom
CL Item
Fatigue (FA)
CL Item
Headache (HE)
CL Item
Muscle Ache (MH)
CL Item
Shivering (SH)
CL Item
Arthralgia (AR)
Item
Study Day
integer
C2826182 (UMLS CUI [1])
Study Day
Code List
Study Day
CL Item
Day 0 (0)
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
Item
Intensity
integer
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Ongoing Symptom
Item
Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Date of Last Day of Symptoms
Item
Date of Last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
Solicited Adverse Events - Temperature
C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0039476 (UMLS CUI-4)
Item
Temperature Measurement Route
text
C0886414 (UMLS CUI [1])
Fever Measurement Route
Code List
Temperature Measurement Route
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
Item
Study Day
integer
C2826182 (UMLS CUI [1])
Study Day
Code List
Study Day
CL Item
Day 0 (0)
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
Body Temperature
Item
Body Temperature
float
C0005903 (UMLS CUI [1])
Ongoing Symptom
Item
Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Date of Last Day of Symptoms
Item
Date of Last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
Other General Symptoms (Day 0 to Day 29)
C0029625 (UMLS CUI-1)
Description
Item
Description
text
C0678257 (UMLS CUI [1])
Item
Intensity
integer
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Ongoing Symptom
Item
Ongoing Symptom
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
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