ID
42320
Description
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
Keywords
Versions (1)
- 5/31/21 5/31/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 31, 2021
DOI
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License
Creative Commons BY 4.0
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Immunogenicity, safety and reactogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with AS03 NCT00385840
Solicited Adverse Events; Unsolicited Adverse Events
- StudyEvent: ODM
Description
Solicited Adverse Events - Local Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-3
- C1457887
- UMLS CUI-4
- C0205276
Description
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Data type
text
Alias
- UMLS CUI [1]
- C0037088
- UMLS CUI [2,1]
- C1515974
- UMLS CUI [2,2]
- C2368628
Description
Solicited Adverse Events - Local Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-3
- C1457887
- UMLS CUI-4
- C0205276
Description
Local Symptoms
Data type
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Description
Redness, Swelling, Ecchymosis - Size - Day
Data type
integer
Alias
- UMLS CUI [1]
- C0332575
- UMLS CUI [2]
- C0038999
- UMLS CUI [3]
- C0013491
Description
Redness Size
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
Description
Swelling Size
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Description
Ecchymosis Size
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0013491
- UMLS CUI [1,2]
- C0456389
Description
Pain Intensity
Data type
integer
Alias
- UMLS CUI [1]
- C1320357
Description
Symptom Ongoing after Day 6?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
Description
If Symptom is Ongoing after Day 6, enter Date of last Day of Symptoms
Data type
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
Description
Medically attended visit
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
Description
Medically attended visit type
Data type
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0332307
Description
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0159028
Description
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0159028
Description
General Symptoms
Data type
text
Alias
- UMLS CUI [1]
- C0159028
Description
Temperature Measurement Site
Data type
text
Alias
- UMLS CUI [1]
- C0489453
Description
Fever, Fatigue, Headache, Muscle Ache, Shivering, Arthralgia - Day
Data type
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
Description
Temperature
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Temperature - Not Done
Data type
integer
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C1272696
Description
Fatigue Intensity
Data type
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0518690
Description
Headache Intensity
Data type
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0518690
Description
Muscle Ache Intensity
Data type
integer
Alias
- UMLS CUI [1,1]
- C0231528
- UMLS CUI [1,2]
- C0518690
Description
Shivering Intensity
Data type
integer
Alias
- UMLS CUI [1,1]
- C0036973
- UMLS CUI [1,2]
- C0518690
Description
Arthralgia intensity
Data type
integer
Alias
- UMLS CUI [1,1]
- C0003862
- UMLS CUI [1,2]
- C0518690
Description
Symptom Ongoing after Day 6?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
Description
If Symptom is Ongoing after Day 6, enter Date of last Day of Symptoms
Data type
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
Description
Causality?
Data type
boolean
Alias
- UMLS CUI [1]
- C0015127
Description
Medically attended visit
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
Description
Medically attended visit type
Data type
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0332307
Description
Unsolicited Adverse Events
Alias
- UMLS CUI-1
- C0877248
Description
Has the subject experienced any serious or non-serious unsolicited adverse events between Visit 1 and Visit 2?
Data type
text
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2]
- C1518404
- UMLS CUI [3]
- C0545082
Similar models
Solicited Adverse Events; Unsolicited Adverse Events
- StudyEvent: ODM
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
C1515974 (UMLS CUI [2,1])
C2368628 (UMLS CUI [2,2])
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
C0038999 (UMLS CUI [2])
C0013491 (UMLS CUI [3])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C1386497 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0159028 (UMLS CUI-2)
C0159028 (UMLS CUI-2)
C0015672 (UMLS CUI [2])
C0018681 (UMLS CUI [3])
C0231528 (UMLS CUI [4])
C0036973 (UMLS CUI [5])
C0003862 (UMLS CUI [6])
C1272696 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C1386497 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2])
C0545082 (UMLS CUI [3])