ID

35165

Beschreibung

Study ID: 107495 Clinical Study ID: 107495 Study Title: A phase II, open, randomized study in adults aged between 18 and 60 years designed to evaluate the reactogenicity and immunogenicity of a 1- and 2-dose prime-boost concept of pandemic monovalent (H5N1) influenza vaccine (split virus formulation) adjuvanted with AS03, administered according to different vaccination schedules. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00430521 https://clinicaltrials.gov/ct2/show/NCT00430521 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Pandemic influenza vaccine (GSK1119711A)-formulation 1, Pandemic influenza vaccine (GSK1119711A)-formulation 2 Trade Name: N/A Study Indication: Influenza There are 4 workbooks (WB): WB 1: Protocol 107495, (H5N1-012), Groups: VT/VT/6Mo, VT/IN/6Mo WB 2: Protocol 107495, (H5N1-012), Groups: VT/VT/12Mo, VT/IN/12Mo WB 3: Protocol 107495 (H5N1-012) GROUPS: 2VT/VT/6MO, 2VT/IN/6MO WB 4: Protocol 107495 (H5N1-012) Groups: 2VT/VT/12Mo, 2VT/IN/12Mo Every Workbook has the following visits: Visit Day 0 (Screening, Dose 1), Visit Day 21, Visit Month 6, Visit Month 12 and Visit Month 18. After Month 6 (+30 days, if applicable) and Month 12 (+30 days, if applicable) there is a Core Analysis section, followed by a final study conclusion after Month 18. Workbook 1 schedules a vaccination at screening and Month 6 each, Workbook 2 at Screening and Month 12. 30 days after the first vaccination there is an additional telephone contact. After the second vaccination additional visits/contacts are necessary in both workbooks: a visit at Month 6/12 + 7 and 21 days and a telephone contact on Month 6/12 + 30 days. Workbook 3 schedules a vaccination at screening, Day 21 and Month 6 and Workbook 4 at screening, Day 21 and Month 12. After the second vaccination there is an additional visit on Day 42 and a telephone contact on day 51. After the third vaccination there are additional visits/contacts: visits at Month 6/12 + 7 and 21 days and a telephone contact at Month 6/12 + 30 days. After Month 6 (+30 days, if applicable) and Month 12 (+30 days, if applicable) there is a Core Analysis section. This document contains the Diary card form. It has to be filled in for: 1) Day 0 - Day 21 (all WB's) 2) Month 6 - Month 6 + 21 days (WB1+3) 3) Month 12 - Month 12 + 21 days (WB2+4) 4) Day 21 - Day 41 (WB3+4)

Link

https://clinicaltrials.gov/ct2/show/NCT00430521

Stichworte

Versionen (2)
  1. 18.02.19 18.02.19 -
  2. 20.02.19 20.02.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. Februar 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Evaluation of reactogenicity and immunogenicity of pandemic monovalent (H5N1) influenza vaccine in adults, NCT00430521

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

text

Alias
UMLS CUI [1]
C2348585
Workbook Number
Beschreibung

Workbook Number

Datentyp

integer

Alias
UMLS CUI [1]
C2986015
Study vaccination
Beschreibung

Study vaccination

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0042196
Vaccination - local symptoms
Beschreibung

Vaccination - local symptoms

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Date of vaccination
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
Local symptoms
Beschreibung

Local symptoms

Datentyp

integer

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

Day of symptom

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C1457887
Size of symptom
Beschreibung

Note for: Redness, Swelling, Ecchymosis and Induration. Please measure the greatest diameter.

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0518690
mm
Intensity of pain
Beschreibung

Note for Pain.

Datentyp

integer

Alias
UMLS CUI [1]
C1320357
Ongoing after Day 6?
Beschreibung

Symptom's ongoing

Datentyp

text

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C1457887
Date of last day of symptom
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Vaccination - Other local symptoms
Beschreibung

Vaccination - Other local symptoms

Alias
UMLS CUI-1
C0205394
UMLS CUI-2
C0042196
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
Description - please specify side(s) and site(s)
Beschreibung

Description of symptom

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0678257
Intensity, other local symptoms
Beschreibung

Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 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 [1,1]
C0518690
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Start date of symptom(s)
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C0808070
End date of symptom(s)
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Symptoms continuing
Beschreibung

Tick if symptoms continuing.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Medication
Beschreibung

Medication

Alias
UMLS CUI-1
C0013227
Trade/ (Generic) Name
Beschreibung

Trade/ (Generic) Name

Datentyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C2347852
Reason for medication
Beschreibung

Reason for medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0566251
Total Daily Dose
Beschreibung

Total Daily Dose

Datentyp

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0439810
Start Date of medication
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date of medication
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Medication continuing
Beschreibung

Tick if medication continuing.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Vacccination - general symptoms
Beschreibung

Vacccination - general symptoms

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0159028
Date of vaccination
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
General symptoms
Beschreibung

General symptoms

Datentyp

integer

Alias
UMLS CUI [1]
C0159028
Day of symptom
Beschreibung

Day of symptom

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C1457887
Measurement of body temperature
Beschreibung

Measurement of body temperature

Datentyp

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
Body temperature
Beschreibung

Please record the axillary temperature every day in the evening. If temperature has been taken more than once a day, please report the highest value for the day. Definition of Fever: Axillary >= 37.5°C, Oral >= 37.5°C

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Intensity of symptom
Beschreibung

For Fatigue, Headache, Myalgia, Shivering, Arthralgia, Sweating increase

Datentyp

integer

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

Symptom's ongoing

Datentyp

text

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C1457887
Date of last day of symptom
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Vaccination - other general symptoms
Beschreibung

Vaccination - other general symptoms

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0029625
Description - please give details
Beschreibung

Description of symptom

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0678257
Intensity, other general symptoms
Beschreibung

Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 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 [1,1]
C0518690
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0159028
Start date of symptom(s)
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C0808070
End date of symptom(s)
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Symptoms continuing
Beschreibung

Tick if symptoms continuing.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Reminder
Beschreibung

Reminder

Alias
UMLS CUI-1
C1709896
Please do not forgive to bring back the diary card on:
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0332156
UMLS CUI [1,3]
C0011008
In case of hospitalisation, please inform:
Beschreibung

Telephone number

Datentyp

integer

Alias
UMLS CUI [1]
C1515258
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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
text
C2348585 (UMLS CUI [1])
Item
Workbook Number
integer
C2986015 (UMLS CUI [1])
Workbook Number
Code List
Workbook Number
CL Item
WB1 (1)
CL Item
WB2 (2)
CL Item
WB3 (3)
CL Item
WB4 (4)
Item
Study vaccination
integer
C0008972 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Study vaccination
Code List
Study vaccination
CL Item
Day 0 - Day 21 (all WB's) (1)
CL Item
Month 6 - Month 6 + 21 days (WB1+3) (2)
CL Item
Month 12 - Month 12 + 21 days (WB2+4) (3)
CL Item
Day 21 - Day 41 (WB3+4) (4)
Item Group
Vaccination - local symptoms
C0042196 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Date of vaccination
Item
Date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item
Local symptoms
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local symptoms
Code List
Local symptoms
CL Item
Redness (1)
CL Item
Swelling (2)
CL Item
Ecchymosis (3)
CL Item
Induration (4)
CL Item
Pain (5)
Item
Day of symptom
integer
C0439228 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Day of symptom
Code List
Day of symptom
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
Size of symptom
Item
Size of symptom
integer
C0456389 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Item
Intensity of pain
integer
C1320357 (UMLS CUI [1])
Intensity of symptom
Code List
Intensity of pain
CL Item
Absent  (0)
CL Item
Painful on touch  (1)
CL Item
Painful when limb is moved  (2)
CL Item
Pain that prevents normal activity (3)
Item
Ongoing after Day 6?
text
C0549178 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Symptom's ongoing
Code List
Ongoing after Day 6?
CL Item
No (N)
CL Item
Yes (Y)
Date of last day of symptom
Item
Date of last day of symptom
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Medically attended visit
Code List
Medically attended visit
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Vaccination - Other local symptoms
C0205394 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Description of symptom
Item
Description - please specify side(s) and site(s)
text
C1457887 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Intensity, other local symptoms
integer
C0518690 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Other local symptoms
Code List
Intensity, other local symptoms
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Start date of symptom(s)
Item
Start date of symptom(s)
date
C0808070 (UMLS CUI [1])
End date of symptom(s)
Item
End date of symptom(s)
date
C0806020 (UMLS CUI [1])
Symptoms continuing
Item
Symptoms continuing
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Medically attended visit
Code List
Medically attended visit
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Medication
C0013227 (UMLS CUI-1)
Trade/ (Generic) Name
Item
Trade/ (Generic) Name
text
C0027365 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Reason for medication
Item
Reason for medication
text
C0013227 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Start Date of medication
Item
Start Date of medication
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date of medication
Item
End Date of medication
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication continuing
Item
Medication continuing
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
Vacccination - general symptoms
C0042196 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
Date of vaccination
Item
Date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item
General symptoms
integer
C0159028 (UMLS CUI [1])
General symptoms
Code List
General symptoms
CL Item
Fever (1)
CL Item
Fatigue (2)
CL Item
Headache (3)
CL Item
Myalgia (4)
CL Item
Shivering (5)
CL Item
Arthralgia (6)
CL Item
Sweating increase (7)
Item
Day of symptom
integer
C0439228 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Day of symptom
Code List
Day of symptom
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
Item
Measurement of body temperature
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Measurement of body temperature
Code List
Measurement of body temperature
CL Item
Axillary (preferable) (A)
CL Item
Oral (O)
Body temperature
Item
Body temperature
float
C0005903 (UMLS CUI [1])
Item
Intensity of symptom
integer
C0518690 (UMLS CUI [1])
Intensity of symptom
Code List
Intensity of symptom
CL Item
Normal (0)
CL Item
Easily tolerated (1)
CL Item
Interferes with normal activity (2)
CL Item
That prevents normal activity (3)
Item
Ongoing after Day 6?
text
C0549178 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Symptom's ongoing
Code List
Ongoing after Day 6?
CL Item
No (N)
CL Item
Yes (Y)
Date of last day of symptom
Item
Date of last day of symptom
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Medically attended visit
Code List
Medically attended visit
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Vaccination - other general symptoms
C0042196 (UMLS CUI-1)
C0029625 (UMLS CUI-2)
Description of symptom
Item
Description - please give details
text
C1457887 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Intensity, other general symptoms
integer
C0518690 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
Other local symptoms
Code List
Intensity, other general symptoms
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Start date of symptom(s)
Item
Start date of symptom(s)
date
C0808070 (UMLS CUI [1])
End date of symptom(s)
Item
End date of symptom(s)
date
C0806020 (UMLS CUI [1])
Symptoms continuing
Item
Symptoms continuing
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Medically attended visit
Code List
Medically attended visit
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Reminder
C1709896 (UMLS CUI-1)
Date of return
Item
Please do not forgive to bring back the diary card on:
date
C3890583 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Telephone number
Item
In case of hospitalisation, please inform:
integer
C1515258 (UMLS CUI [1])
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