ID

42319

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)
  1. 29.05.21 29.05.21 -
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GlaxoSmithKline

Hochgeladen am

29. Mai 2021

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

Englisch

Visit 1, Day 0 Vaccination: General Medical History/ Physical Examination; Laboratory Tests; Vaccine Administration

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
General Medical History/ Physical Examination
Beschreibung

General Medical History/ Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Are you aware of any pre-existing conditions, signs or symptoms present history since Day 180 of FLU-LD-006 EXT-002 (D180) study?
Beschreibung

If Yes, please give diagnosis and tick appropriate Past/Current box(es).

Datentyp

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C0037088
General Medical History/ Physical Examination
Beschreibung

General Medical History/ Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
MedDRA System Organ Class
Beschreibung

MedDRA System Organ Class

Datentyp

integer

Alias
UMLS CUI [1]
C2347091
Diagnosis
Beschreibung

Diagnosis

Datentyp

text

Alias
UMLS CUI [1]
C0011900
Disease Status
Beschreibung

Disease Status

Datentyp

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
Laboratory Tests
Beschreibung

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Blood Sample - HI Antibody Determination: Has a blood sample been taken for (serum) HI antibody determination?
Beschreibung

Blood Sample - HI Antibody Determination: Has a blood sample been taken for (serum) HI antibody determination?

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
UMLS CUI [2]
C0003241
UMLS CUI [3]
C0021400
HI Antibody Determination Date
Beschreibung

Please complete only if different from visit date

Datentyp

date

Alias
UMLS CUI [1,1]
C0003241
UMLS CUI [1,2]
C0021400
UMLS CUI [2,1]
C1148554
UMLS CUI [2,2]
C0011008
Vaccine Administration
Beschreibung

Vaccine Administration

Alias
UMLS CUI-1
C2368628
Date of Vaccine Administration
Beschreibung

(fill in only if different from visit date)

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
Pre-Vaccination temperature
Beschreibung

Pre-Vaccination temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C0332152
°C
Temperatur measurement route
Beschreibung

Temperatur measurement route

Datentyp

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
Vaccine Administration
Beschreibung

Vaccine Administration

Alias
UMLS CUI-1
C2368628
Vaccine Administration
Beschreibung

Vaccine Administration

Datentyp

text

Alias
UMLS CUI [1]
C2368628
Replacement vial number
Beschreibung

Replacement vial number

Datentyp

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0600091
Wrong vial number
Beschreibung

Wrong vial number

Datentyp

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C0600091
Has the study vaccine been administered according to the Protocol?
Beschreibung

Has the study vaccine been administered according to the Protocol?

Datentyp

boolean

Alias
UMLS CUI [1]
C2368628
UMLS CUI [2]
C2348563
If study vaccine has not been administered according to the Protocol, specify Side
Beschreibung

If study vaccine has not been administered according to the Protocol, specify Side

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0441987
If study vaccine has not been administered according to the Protocol, specify Site
Beschreibung

If study vaccine has not been administered according to the Protocol, specify Site

Datentyp

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C1515974
If study vaccine has not been administered according to the Protocol, specify Route
Beschreibung

If study vaccine has not been administered according to the Protocol, specify Route

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0013153
Please tick the major reason for non administration
Beschreibung

Please tick the major reason for non administration

Datentyp

text

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Please specify SAE No.
Beschreibung

Please specify SAE No.

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Please specify AE No.
Beschreibung

Please specify AE No.

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Specify other reason for non administration
Beschreibung

(e.g.: consent withdrawal, Protocol violation, …)

Datentyp

text

Alias
UMLS CUI [1]
C1533734
UMLS CUI [2,1]
C0392360
UMLS CUI [2,2]
C1272696
UMLS CUI [3]
C0205394
UMLS CUI [4]
C2348235
Please tick who made decision (for non administration)
Beschreibung

Please tick who made decision (for non administration)

Datentyp

text

Alias
UMLS CUI [1]
C0679006
UMLS CUI [2,1]
C1533734
UMLS CUI [2,2]
C1272696
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Ähnliche Modelle

Visit 1, Day 0 Vaccination: General Medical History/ Physical Examination; Laboratory Tests; Vaccine Administration

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
General Medical History/ Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Are you aware of any pre-existing conditions, signs or symptoms present history since Day 180 of FLU-LD-006 EXT-002 (D180) study?
Item
Are you aware of any pre-existing conditions, signs or symptoms present history since Day 180 of FLU-LD-006 EXT-002 (D180) study?
boolean
C0012634 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
Item Group
General Medical History/ Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Item
MedDRA System Organ Class
integer
C2347091 (UMLS CUI [1])
MedDRA System Organ Class
Code List
MedDRA System Organ Class
CL Item
Skin and subcutaneous tissue (1)
CL Item
Musculoskeletal and connective tissue (2)
CL Item
Cardiac (3)
CL Item
Vascular (4)
CL Item
Respiratory, thoracic and mediastinal (5)
CL Item
Gastrointestinal (6)
CL Item
Hepatobiliary (7)
CL Item
Renal and urinary (8)
CL Item
Nervous system (9)
CL Item
Eye (10)
CL Item
Ear and labyrinth (11)
CL Item
Endocrine (12)
CL Item
Metabolism and nutrition (13)
CL Item
Blood and lymphatic system (14)
CL Item
Immune system (incl allergies, autoimmune disorders) (15)
CL Item
Infections and infestations (16)
CL Item
Neoplasms benign, malignant and unspecified (incl cysts, polyps) (17)
CL Item
Surgical and medical procedures (18)
CL Item
Other (19)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Disease Status
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Disease Status
Code List
Disease Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Blood Sample - HI Antibody Determination: Has a blood sample been taken for (serum) HI antibody determination?
Item
Blood Sample - HI Antibody Determination: Has a blood sample been taken for (serum) HI antibody determination?
boolean
C0005834 (UMLS CUI [1])
C0003241 (UMLS CUI [2])
C0021400 (UMLS CUI [3])
HI Antibody Determination Date
Item
HI Antibody Determination Date
date
C0003241 (UMLS CUI [1,1])
C0021400 (UMLS CUI [1,2])
C1148554 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Item Group
Vaccine Administration
C2368628 (UMLS CUI-1)
Date of Vaccine Administration
Item
Date of Vaccine Administration
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1])
C0042196 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Item
Temperatur measurement route
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Temperatur measurement route
Code List
Temperatur measurement route
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (not recommended) (R)
Item Group
Vaccine Administration
C2368628 (UMLS CUI-1)
Item
Vaccine Administration
text
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
Study Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (Please complete following pages) (N)
Replacement vial number
Item
Replacement vial number
text
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Wrong vial number
Item
Wrong vial number
text
C0184301 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1])
C2348563 (UMLS CUI [2])
Item
If study vaccine has not been administered according to the Protocol, specify Side
text
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0441987 (UMLS CUI [2])
If study vaccine has not been administered according to the Protocol, specify Side
Code List
If study vaccine has not been administered according to the Protocol, specify Side
CL Item
Dominant (D)
CL Item
Non dominant (N)
Item
If study vaccine has not been administered according to the Protocol, specify Site
integer
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2])
If study vaccine has not been administered according to the Protocol, specify Site
Code List
If study vaccine has not been administered according to the Protocol, specify Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
If study vaccine has not been administered according to the Protocol, specify Route
text
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0013153 (UMLS CUI [2])
If study vaccine has not been administered according to the Protocol, specify Route
Code List
If study vaccine has not been administered according to the Protocol, specify Route
CL Item
I.M. (IM)
CL Item
S.C. (SC)
Item
Please tick the major reason for non administration
text
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Please tick the major reason for non administration
Code List
Please tick the major reason for non administration
CL Item
Serious adverse event (Please complete and submit SAE report) (SAE)
CL Item
Non-Serious adverse event (Please complete Non-Serious Adverse Event section) (AEX)
CL Item
Other, please specify (OTH)
Please specify SAE No.
Item
Please specify SAE No.
text
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Please specify AE No.
Item
Please specify AE No.
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Specify other reason for non administration
Item
Specify other reason for non administration
text
C1533734 (UMLS CUI [1])
C0392360 (UMLS CUI [2,1])
C1272696 (UMLS CUI [2,2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
Item
Please tick who made decision (for non administration)
text
C0679006 (UMLS CUI [1])
C1533734 (UMLS CUI [2,1])
C1272696 (UMLS CUI [2,2])
Please tick who made decision (for non administration)
Code List
Please tick who made decision (for non administration)
CL Item
Investigator (I)
CL Item
Subject (S)
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