ID
35048
Beschrijving
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
Trefwoorden
Versies (3)
- 12-02-19 12-02-19 -
- 16-02-19 16-02-19 -
- 22-02-19 22-02-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
12 februari 2019
DOI
Voor een aanvraag inloggen.
Licentie
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
Diary Card
- StudyEvent: ODM
Beschrijving
Solicited Adverse Events Record - Local Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0042196
Beschrijving
Local Symptom
Datatype
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Beschrijving
Symptom Occurrence
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2745955
Beschrijving
Study Day
Datatype
integer
Alias
- UMLS CUI [1]
- C2826182
Beschrijving
Intensity: Pain (at injection site): 0:Absent. 1:Painful on touch. 2:Painful when limb is moved. 3:Spontaneously painful / prevents normal activity.
Datatype
integer
Beschrijving
Please measure the greatest diameter (in mm), if redness, swelling or ecchymosis is ticked
Datatype
integer
Maateenheden
- mm
Beschrijving
Ongoing Symptom
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Beschrijving
if ongoing after Day 6
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Beschrijving
Other Local Symptoms (Day 0 to Day 29)
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0042196
Beschrijving
please specify side(s) and site(s
Datatype
text
Alias
- UMLS CUI [1]
- C0678257
Beschrijving
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).
Datatype
integer
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
End Date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
tick box if continuing
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Beschrijving
Medication
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Trade/Generic Name
Datatype
text
Alias
- UMLS CUI [1]
- C2360065
Beschrijving
Reason
Datatype
text
Alias
- UMLS CUI [1]
- C0392360
Beschrijving
Total Daily Dose
Datatype
text
Alias
- UMLS CUI [1]
- C2348070
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
End Date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
tick box if continuing
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Beschrijving
Solicited Adverse Events Record - General Symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Beschrijving
arthralgia = joint pain
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C1556354
Beschrijving
Symptom Occurrence
Datatype
boolean
Beschrijving
Study Day
Datatype
integer
Alias
- UMLS CUI [1]
- C2826182
Beschrijving
Fatigue, Headache, Muscle Ache, Shivering, Arthralgia/Joint Pain 0: Normal 1: Easily tolerated 2: Interferes with normal activity 3: That prevents normal activity
Datatype
integer
Beschrijving
Ongoing Symptom
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Beschrijving
Date of Last Day of Symptoms
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Beschrijving
Solicited Adverse Events - Fever
Beschrijving
Fever: Axillary > 37.5°C Oral > 37.5°C Rectal > 38° C Temperature: Please record the temperature every day in the evening. Should additional temperature measurements be performed at other times of the day, the highest temperature is to be recorded.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
If fever is ticked oral is preferred
Datatype
text
Alias
- UMLS CUI [1,1]
- C0449687
- UMLS CUI [1,2]
- C0015967
Beschrijving
Study Day
Datatype
integer
Alias
- UMLS CUI [1]
- C2826182
Beschrijving
Body Temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Ongoing Symptom
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Beschrijving
Date of Last Day of Symptoms
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Beschrijving
Other General Symptoms (Day 0 to Day 29)
Alias
- UMLS CUI-1
- C0029625
Beschrijving
please specify side(s) and site(s
Datatype
text
Alias
- UMLS CUI [1]
- C0678257
Beschrijving
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).
Datatype
integer
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
End Date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
tick box if continuing
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Similar models
Diary Card
- StudyEvent: ODM
C0042196 (UMLS CUI [1,2])
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C2745955 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C3174772 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0159028 (UMLS CUI [1,2])
C1556354 (UMLS CUI [1,3])
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0015967 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C3174772 (UMLS CUI [1,2])