ID
42320
Beschreibung
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
Stichworte
Versionen (1)
- 31.05.21 31.05.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
31. Mai 2021
DOI
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Lizenz
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
Beschreibung
Solicited Adverse Events - Local Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-3
- C1457887
- UMLS CUI-4
- C0205276
Beschreibung
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Datentyp
text
Alias
- UMLS CUI [1]
- C0037088
- UMLS CUI [2,1]
- C1515974
- UMLS CUI [2,2]
- C2368628
Beschreibung
Solicited Adverse Events - Local Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-3
- C1457887
- UMLS CUI-4
- C0205276
Beschreibung
Local Symptoms
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Beschreibung
Redness, Swelling, Ecchymosis - Size - Day
Datentyp
integer
Alias
- UMLS CUI [1]
- C0332575
- UMLS CUI [2]
- C0038999
- UMLS CUI [3]
- C0013491
Beschreibung
Redness Size
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
Beschreibung
Swelling Size
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Beschreibung
Ecchymosis Size
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0013491
- UMLS CUI [1,2]
- C0456389
Beschreibung
Pain Intensity
Datentyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beschreibung
Symptom Ongoing after Day 6?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
Beschreibung
If Symptom is Ongoing after Day 6, enter Date of last Day of Symptoms
Datentyp
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
Beschreibung
Medically attended visit
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
Beschreibung
Medically attended visit type
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0332307
Beschreibung
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0159028
Beschreibung
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0159028
Beschreibung
General Symptoms
Datentyp
text
Alias
- UMLS CUI [1]
- C0159028
Beschreibung
Temperature Measurement Site
Datentyp
text
Alias
- UMLS CUI [1]
- C0489453
Beschreibung
Fever, Fatigue, Headache, Muscle Ache, Shivering, Arthralgia - Day
Datentyp
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
Beschreibung
Temperature
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Temperature - Not Done
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C1272696
Beschreibung
Fatigue Intensity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0518690
Beschreibung
Headache Intensity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0518690
Beschreibung
Muscle Ache Intensity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0231528
- UMLS CUI [1,2]
- C0518690
Beschreibung
Shivering Intensity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0036973
- UMLS CUI [1,2]
- C0518690
Beschreibung
Arthralgia intensity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0003862
- UMLS CUI [1,2]
- C0518690
Beschreibung
Symptom Ongoing after Day 6?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
Beschreibung
If Symptom is Ongoing after Day 6, enter Date of last Day of Symptoms
Datentyp
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
Beschreibung
Causality?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015127
Beschreibung
Medically attended visit
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
Beschreibung
Medically attended visit type
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0332307
Beschreibung
Unsolicited Adverse Events
Alias
- UMLS CUI-1
- C0877248
Beschreibung
Has the subject experienced any serious or non-serious unsolicited adverse events between Visit 1 and Visit 2?
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2]
- C1518404
- UMLS CUI [3]
- C0545082
Ähnliche Modelle
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])