ID

42320

Beschrijving

Study ID: 108708 Clinical Study ID: 108708 Study Title: A phase IIb, controlled, randomized, multicentre, observer blinded study to evaluate the immunogenicity, safety and reactogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with AS03 compared to a second dose of FluarixTM (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years previously vaccinated in FLU-LD-002 clinical trial Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00385840 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Influenza Vaccine GSK1247446A Trade Name: FluarixTM Study Indication: Influenza

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  1. 31-05-21 31-05-21 -
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GlaxoSmithKline

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31 mei 2021

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Immunogenicity, safety and reactogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with AS03 NCT00385840

Engels

Solicited Adverse Events; Unsolicited Adverse Events

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Solicited Adverse Events - Local Symptoms
Beschrijving

Solicited Adverse Events - Local Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Beschrijving

Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?

Datatype

text

Alias
UMLS CUI [1]
C0037088
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C2368628
Solicited Adverse Events - Local Symptoms
Beschrijving

Solicited Adverse Events - Local Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
Local Symptoms
Beschrijving

Local Symptoms

Datatype

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Redness, Swelling, Ecchymosis - Day
Beschrijving

Redness, Swelling, Ecchymosis - Size - Day

Datatype

integer

Alias
UMLS CUI [1]
C0332575
UMLS CUI [2]
C0038999
UMLS CUI [3]
C0013491
Redness Size
Beschrijving

Redness Size

Datatype

integer

Maateenheden
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
mm
Swelling Size
Beschrijving

Swelling Size

Datatype

integer

Maateenheden
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Ecchymosis Size
Beschrijving

Ecchymosis Size

Datatype

integer

Maateenheden
  • mm
Alias
UMLS CUI [1,1]
C0013491
UMLS CUI [1,2]
C0456389
mm
Pain Intensity
Beschrijving

Pain Intensity

Datatype

integer

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

Symptom Ongoing after Day 6?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
If Symptom is Ongoing after Day 6, enter Date of last Day of Symptoms
Beschrijving

If Symptom is Ongoing after Day 6, enter Date of last Day of Symptoms

Datatype

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Medically attended visit
Beschrijving

Medically attended visit

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Medically attended visit type
Beschrijving

Medically attended visit type

Datatype

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0332307
Solicited Adverse Events - General Symptoms
Beschrijving

Solicited Adverse Events - General Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0159028
Has the subject experienced any of the following signs/symptoms during the solicited period?
Beschrijving

Has the subject experienced any of the following signs/symptoms during the solicited period?

Datatype

text

Alias
UMLS CUI [1]
C0037088
Solicited Adverse Events - General Symptoms
Beschrijving

Solicited Adverse Events - General Symptoms

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

General Symptoms

Datatype

text

Alias
UMLS CUI [1]
C0159028
Temperature Measurement Site
Beschrijving

Temperature Measurement Site

Datatype

text

Alias
UMLS CUI [1]
C0489453
Fever, Fatigue, Headache, Muscle Ache, Shivering, Arthralgia - Day
Beschrijving

Fever, Fatigue, Headache, Muscle Ache, Shivering, Arthralgia - Day

Datatype

integer

Alias
UMLS CUI [1]
C0015967
UMLS CUI [2]
C0015672
UMLS CUI [3]
C0018681
UMLS CUI [4]
C0231528
UMLS CUI [5]
C0036973
UMLS CUI [6]
C0003862
Temperature
Beschrijving

Temperature

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature - Not Done
Beschrijving

Temperature - Not Done

Datatype

integer

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C1272696
Fatigue Intensity
Beschrijving

Fatigue Intensity

Datatype

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
Headache Intensity
Beschrijving

Headache Intensity

Datatype

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
Muscle Ache Intensity
Beschrijving

Muscle Ache Intensity

Datatype

integer

Alias
UMLS CUI [1,1]
C0231528
UMLS CUI [1,2]
C0518690
Shivering Intensity
Beschrijving

Shivering Intensity

Datatype

integer

Alias
UMLS CUI [1,1]
C0036973
UMLS CUI [1,2]
C0518690
Arthralgia intensity
Beschrijving

Arthralgia intensity

Datatype

integer

Alias
UMLS CUI [1,1]
C0003862
UMLS CUI [1,2]
C0518690
Symptom Ongoing after Day 6?
Beschrijving

Symptom Ongoing after Day 6?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
If Symptom is Ongoing after Day 6, enter Date of last Day of Symptoms
Beschrijving

If Symptom is Ongoing after Day 6, enter Date of last Day of Symptoms

Datatype

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Causality?
Beschrijving

Causality?

Datatype

boolean

Alias
UMLS CUI [1]
C0015127
Medically attended visit
Beschrijving

Medically attended visit

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Medically attended visit type
Beschrijving

Medically attended visit type

Datatype

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0332307
Unsolicited Adverse Events
Beschrijving

Unsolicited Adverse Events

Alias
UMLS CUI-1
C0877248
Has the subject experienced any serious or non-serious unsolicited adverse events between Visit 1 and Visit 2?
Beschrijving

Has the subject experienced any serious or non-serious unsolicited adverse events between Visit 1 and Visit 2?

Datatype

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C1518404
UMLS CUI [3]
C0545082
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Similar models

Solicited Adverse Events; Unsolicited Adverse Events

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Solicited Adverse Events - Local Symptoms
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C0037088 (UMLS CUI [1])
C1515974 (UMLS CUI [2,1])
C2368628 (UMLS CUI [2,2])
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
Item Group
Solicited Adverse Events - Local Symptoms
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
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
Pain (4)
Item
Redness, Swelling, Ecchymosis - Day
integer
C0332575 (UMLS CUI [1])
C0038999 (UMLS CUI [2])
C0013491 (UMLS CUI [3])
Redness, Swelling, Ecchymosis - Size - Day
Code List
Redness, Swelling, Ecchymosis - Day
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)
Redness Size
Item
Redness Size
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size
Item
Swelling Size
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Ecchymosis Size
Item
Ecchymosis Size
integer
C0013491 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Item
Pain Intensity
integer
C1320357 (UMLS CUI [1])
Pain Intensity
Code List
Pain Intensity
CL Item
Absent (0)
CL Item
Painful on touch (1)
CL Item
Painful when limb is moved (2)
CL Item
Spontaneously painful / prevents normal activity (3)
Symptom Ongoing after Day 6?
Item
Symptom Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
If Symptom is Ongoing after Day 6, enter Date of last Day of Symptoms
Item
If Symptom is Ongoing after Day 6, enter Date of last Day of Symptoms
date
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Item
Medically attended visit type
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Medically attended visit type
Code List
Medically attended visit type
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Item Group
Solicited Adverse Events - General Symptoms
C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C0037088 (UMLS CUI [1])
Has the subject experienced any of the following signs/symptoms during the solicited period?
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
Item Group
Solicited Adverse Events - General Symptoms
C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
Item
General Symptoms
text
C0159028 (UMLS CUI [1])
General Symptoms
Code List
General Symptoms
CL Item
Fever (FE)
CL Item
Fatigue (FA)
CL Item
Headache (HE)
CL Item
Muscle Ache (MH)
CL Item
Shivering (SH)
CL Item
Arthralgia (AR)
Item
Temperature Measurement Site
text
C0489453 (UMLS CUI [1])
Temperature Measurement Site
Code List
Temperature Measurement Site
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (not recommended) (R)
Item
Fever, Fatigue, Headache, Muscle Ache, Shivering, Arthralgia - Day
integer
C0015967 (UMLS CUI [1])
C0015672 (UMLS CUI [2])
C0018681 (UMLS CUI [3])
C0231528 (UMLS CUI [4])
C0036973 (UMLS CUI [5])
C0003862 (UMLS CUI [6])
Fever, Fatigue, Headache, Muscle Ache, Shivering, Arthralgia - Day
Code List
Fever, Fatigue, Headache, Muscle Ache, Shivering, Arthralgia - Day
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)
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Temperature - Not Done
integer
C0886414 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Temperature - Not Done
Code List
Temperature - Not Done
CL Item
Not Taken (1)
Item
Fatigue Intensity
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Fatigue Intensity
Code List
Fatigue Intensity
CL Item
Normal (0)
CL Item
Easily tolerated (1)
CL Item
Interferes with normal activity (2)
CL Item
That prevents normal activity (3)
Item
Headache Intensity
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Headache Intensity
Code List
Headache Intensity
CL Item
Normal  (0)
CL Item
Easily tolerated  (1)
CL Item
Interferes with normal activity  (2)
CL Item
That prevents normal activity (3)
Item
Muscle Ache Intensity
integer
C0231528 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Muscle Ache Intensity
Code List
Muscle Ache Intensity
CL Item
Normal  (0)
CL Item
Easily tolerated  (1)
CL Item
Interferes with normal activity  (2)
CL Item
That prevents normal activity (3)
Item
Shivering Intensity
integer
C0036973 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Shivering Intensity
Code List
Shivering Intensity
CL Item
Normal  (0)
CL Item
Easily tolerated  (1)
CL Item
Interferes with normal activity  (2)
CL Item
That prevents normal activity (3)
Item
Arthralgia intensity
integer
C0003862 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Arthralgia intensity
Code List
Arthralgia intensity
CL Item
Normal  (0)
CL Item
Easily tolerated  (1)
CL Item
Interferes with normal activity  (2)
CL Item
That prevents normal activity (3)
Symptom Ongoing after Day 6?
Item
Symptom Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
If Symptom is Ongoing after Day 6, enter Date of last Day of Symptoms
Item
If Symptom is Ongoing after Day 6, enter Date of last Day of Symptoms
date
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Causality?
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Item
Medically attended visit type
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Medically attended visit type
Code List
Medically attended visit type
CL Item
Hospitalization  (HO)
CL Item
Emergency Room  (ER)
CL Item
Medical Personnel (MD)
Item Group
Unsolicited Adverse Events
C0877248 (UMLS CUI-1)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events between Visit 1 and Visit 2?
text
C1519255 (UMLS CUI [1])
C1518404 (UMLS CUI [2])
C0545082 (UMLS CUI [3])
Has the subject experienced any serious or non-serious unsolicited adverse events between Visit 1 and Visit 2?
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events between Visit 1 and Visit 2?
CL Item
Information not available (U)
CL Item
No vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Fill in the Non-Serious Adverse Event section or Serious Adverse Event report, as appropriate) (Y)
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