ID
42319
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)
- 5/29/21 5/29/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 29, 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
Visit 1, Day 0 Vaccination: General Medical History/ Physical Examination; Laboratory Tests; Vaccine Administration
Description
General Medical History/ Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Description
General Medical History/ Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Description
MedDRA System Organ Class
Data type
integer
Alias
- UMLS CUI [1]
- C2347091
Description
Diagnosis
Data type
text
Alias
- UMLS CUI [1]
- C0011900
Description
Disease Status
Data type
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Description
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Description
Blood Sample - HI Antibody Determination: Has a blood sample been taken for (serum) HI antibody determination?
Data type
boolean
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0003241
- UMLS CUI [3]
- C0021400
Description
Please complete only if different from visit date
Data type
date
Alias
- UMLS CUI [1,1]
- C0003241
- UMLS CUI [1,2]
- C0021400
- UMLS CUI [2,1]
- C1148554
- UMLS CUI [2,2]
- C0011008
Description
Vaccine Administration
Alias
- UMLS CUI-1
- C2368628
Description
(fill in only if different from visit date)
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2368628
Description
Pre-Vaccination temperature
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
- UMLS CUI [2,1]
- C0042196
- UMLS CUI [2,2]
- C0332152
Description
Temperatur measurement route
Data type
text
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C0449444
Description
Vaccine Administration
Alias
- UMLS CUI-1
- C2368628
Description
Vaccine Administration
Data type
text
Alias
- UMLS CUI [1]
- C2368628
Description
Replacement vial number
Data type
text
Alias
- UMLS CUI [1,1]
- C0184301
- UMLS CUI [1,2]
- C0559956
- UMLS CUI [1,3]
- C0600091
Description
Wrong vial number
Data type
text
Alias
- UMLS CUI [1,1]
- C0184301
- UMLS CUI [1,2]
- C3827420
- UMLS CUI [1,3]
- C0600091
Description
Has the study vaccine been administered according to the Protocol?
Data type
boolean
Alias
- UMLS CUI [1]
- C2368628
- UMLS CUI [2]
- C2348563
Description
If study vaccine has not been administered according to the Protocol, specify Side
Data type
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
- UMLS CUI [2]
- C0441987
Description
If study vaccine has not been administered according to the Protocol, specify Site
Data type
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
- UMLS CUI [2]
- C1515974
Description
If study vaccine has not been administered according to the Protocol, specify Route
Data type
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
- UMLS CUI [2]
- C0013153
Description
Please tick the major reason for non administration
Data type
text
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C1272696
Description
Please specify SAE No.
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Description
Please specify AE No.
Data type
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Description
(e.g.: consent withdrawal, Protocol violation, …)
Data type
text
Alias
- UMLS CUI [1]
- C1533734
- UMLS CUI [2,1]
- C0392360
- UMLS CUI [2,2]
- C1272696
- UMLS CUI [3]
- C0205394
- UMLS CUI [4]
- C2348235
Description
Please tick who made decision (for non administration)
Data type
text
Alias
- UMLS CUI [1]
- C0679006
- UMLS CUI [2,1]
- C1533734
- UMLS CUI [2,2]
- C1272696
Similar models
Visit 1, Day 0 Vaccination: General Medical History/ Physical Examination; Laboratory Tests; Vaccine Administration
C0031809 (UMLS CUI-2)
C0037088 (UMLS CUI [2])
C0031809 (UMLS CUI-2)
C0003241 (UMLS CUI [2])
C0021400 (UMLS CUI [3])
C0021400 (UMLS CUI [1,2])
C1148554 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C2368628 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0449444 (UMLS CUI [1,2])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C3827420 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C2348563 (UMLS CUI [2])
C2348563 (UMLS CUI [1,2])
C0441987 (UMLS CUI [2])
C2348563 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2])
C2348563 (UMLS CUI [1,2])
C0013153 (UMLS CUI [2])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2,1])
C1272696 (UMLS CUI [2,2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
C1533734 (UMLS CUI [2,1])
C1272696 (UMLS CUI [2,2])