ID

35020

Description

Study ID: 107022 Clinical Study ID: 107022 Study Title: A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00321373 Study Link: https://clinicaltrials.gov/ct2/show/NCT00321373 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Trade Name: FluarixTM Study Indication: Influenza The purpose of this form is to document the vaccine administration at visit 1. Subjects only receive one of the vaccinations in this form. Fill out accordingly. IMMEDIATE POST-VACCINATION OBSERVATION If any adverse events occurred during the immediate post-vaccination time (30 minutes) please fill in the Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event report. If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick prophylactic box. Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1

Link

https://clinicaltrials.gov/ct2/show/NCT00321373

Keywords

Versions (3)
  1. 2/1/19 2/1/19 -
  2. 2/6/19 2/6/19 -
  3. 2/10/19 2/10/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 10, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373

English

Vaccine Administration

1 forms  
  1. StudyEvent: ODM
    1. Vaccine Administration
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Vaccine Administration
Description

Vaccine Administration

Alias
UMLS CUI-1
C2368628
Date
Description

Fill in only if different from visit date

Data type

date

Alias
UMLS CUI [1]
C0011008
Pre Vaccination Temperature
Description

Pre Vaccination Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Route
Description

Temperature Route

Data type

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0449687
Flu/AS03/5 Vaccine Administration
Description

Flu/AS03/5 Vaccine Administration

Alias
UMLS CUI-1
C0042200
UMLS CUI-2
C1533734
UMLS CUI-3
C1522673
Vaccine Administration
Description

Vaccine Administration

Data type

text

Alias
UMLS CUI [1]
C2368628
Replacement vial
Description

Only applies if replacement vial was used

Data type

integer

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0600091
Wrong Vial Number
Description

Only applies if wrong vial was used

Data type

integer

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

Vaccination according to Study Protocol: Non dominant, Deltoid, I.M.

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
Vaccination Side
Description

Only applies if vaccinatino has not been administered according to study protocol

Data type

text

Alias
UMLS CUI [1]
C0441987
Vaccination Site
Description

Only applies if vaccinatino has not been administered according to study protocol

Data type

integer

Alias
UMLS CUI [1,1]
C1116171
UMLS CUI [1,2]
C0005898
Route
Description

Only applies if vaccinatino has not been administered according to study protocol

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Flu/5 Vaccine Administration
Description

Flu/5 Vaccine Administration

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0042200
Vaccine Administration
Description

Vaccine Administration

Data type

text

Alias
UMLS CUI [1]
C2368628
Replacement vial
Description

Only applies if replacement vial was used

Data type

integer

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0600091
Wrong Vial Number
Description

Only applies if wrong vial was used

Data type

integer

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

Vaccination according to Study Protocol: Non dominant, Deltoid, I.M.

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
Vaccination Side
Description

Only applies if vaccinatino has not been administered according to study protocol

Data type

text

Alias
UMLS CUI [1]
C0441987
Vaccination Site
Description

Only applies if vaccinatino has not been administered according to study protocol

Data type

integer

Alias
UMLS CUI [1,1]
C1116171
UMLS CUI [1,2]
C0005898
Route
Description

Only applies if vaccinatino has not been administered according to study protocol

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Fluarix Vaccine
Description

Fluarix Vaccine

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0021403
UMLS CUI-3
C0591524
Vaccine Administration
Description

Vaccine Administration

Data type

text

Alias
UMLS CUI [1]
C2368628
Replacement vial
Description

Only applies if replacement vial was used

Data type

integer

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0600091
Wrong Vial Number
Description

Only applies if wrong vial was used

Data type

integer

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

Vaccination according to Study Protocol: Non dominant, Deltoid, I.M.

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
Vaccination Side
Description

Only applies if vaccinatino has not been administered according to study protocol

Data type

text

Alias
UMLS CUI [1]
C0441987
Vaccination Site
Description

Only applies if vaccinatino has not been administered according to study protocol

Data type

integer

Alias
UMLS CUI [1,1]
C1116171
UMLS CUI [1,2]
C0005898
Route
Description

Only applies if vaccinatino has not been administered according to study protocol

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Reason for not Administration
Description

Reason for not Administration

Alias
UMLS CUI-1
C1533734
UMLS CUI-2
C0392360
UMLS CUI-3
C1272696
Why not Administered
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
Please specify SAE No.
Description

If SAE was the primary reason for not administration Please complete and submit SAE report

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0600091
Please specify AE No.
Description

If AE was the primary reason for non-administration Please complete Non-Serious Adverse Event section

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0600091
Other, please specify
Description

If there was any other reason for non-administration (e.g.: consent withdrawal, Protocol violation, …)

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Please tick who made the decision
Description

Decision Made By

Data type

text

Alias
UMLS CUI [1]
C0679006
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Similar models

Vaccine Administration

1 forms
  1. StudyEvent: ODM
    1. Vaccine Administration
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Vaccine Administration
C2368628 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Pre Vaccination Temperature
Item
Pre Vaccination Temperature
float
C0005903 (UMLS CUI [1])
Item
Route
text
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
Temperature Route
Code List
Route
CL Item
Axillary (A)
CL Item
Oral (preferred) (O)
CL Item
Rectal (R)
Item Group
Flu/AS03/5 Vaccine Administration
C0042200 (UMLS CUI-1)
C1533734 (UMLS CUI-2)
C1522673 (UMLS CUI-3)
Item
Vaccine Administration
text
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
Flu/5 Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (N)
CL Item
AS03 (A)
Replacement vial
Item
Replacement vial
integer
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Wrong Vial Number
Item
Wrong Vial Number
integer
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
Vaccine Administration according to Protocol
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
Vaccination Side
text
C0441987 (UMLS CUI [1])
Vaccination Side
Code List
Vaccination Side
CL Item
Dominant (R)
CL Item
Non Dominant (N)
Item
Vaccination Site
integer
C1116171 (UMLS CUI [1,1])
C0005898 (UMLS CUI [1,2])
Vaccination Site
Code List
Vaccination Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
I.M. (IM)
CL Item
S.C. (SC)
Item Group
Flu/5 Vaccine Administration
C2368628 (UMLS CUI-1)
C0042200 (UMLS CUI-2)
Item
Vaccine Administration
text
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
Flu/5 Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (N)
Replacement vial
Item
Replacement vial
integer
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Wrong Vial Number
Item
Wrong Vial Number
integer
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
Vaccine Administration according to Protocol
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
Vaccination Side
text
C0441987 (UMLS CUI [1])
Vaccination Side
Code List
Vaccination Side
CL Item
Dominant (R)
CL Item
Non Dominant (N)
Item
Vaccination Site
integer
C1116171 (UMLS CUI [1,1])
C0005898 (UMLS CUI [1,2])
Vaccination Site
Code List
Vaccination Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
I.M. (IM)
CL Item
S.C. (SC)
Item Group
Fluarix Vaccine
C2368628 (UMLS CUI-1)
C0021403 (UMLS CUI-2)
C0591524 (UMLS CUI-3)
Item
Vaccine Administration
text
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
Fluarix Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (N)
Replacement vial
Item
Replacement vial
integer
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Wrong Vial Number
Item
Wrong Vial Number
integer
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
Vaccine Administration according to Protocol
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
Vaccination Side
text
C0441987 (UMLS CUI [1])
Vaccination Side
Code List
Vaccination Side
CL Item
Dominant (R)
CL Item
Non Dominant (N)
Item
Vaccination Site
integer
C1116171 (UMLS CUI [1,1])
C0005898 (UMLS CUI [1,2])
Vaccination Site
Code List
Vaccination Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
I.M. (IM)
CL Item
S.C. (SC)
Item Group
Reason for not Administration
C1533734 (UMLS CUI-1)
C0392360 (UMLS CUI-2)
C1272696 (UMLS CUI-3)
Item
Why not Administered
text
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Reason for Not Administration
Code List
Why not Administered
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Other (OTH)
SAE No.
Item
Please specify SAE No.
integer
C1519255 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
AE No.
Item
Please specify AE No.
integer
C0877248 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Other Specification
Item
Other, please specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Please tick who made the decision
text
C0679006 (UMLS CUI [1])
Decision Made By
Code List
Please tick who made the decision
CL Item
Investigator (I)
CL Item
Subject (S)
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