ID

35094

Beschrijving

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 his form is to document if the subject has had any adverse events in the course of the study. It should be filled out at the date of vaccination. SERIOUS ADVERSE EVENT A serious adverse event is any untoward medical occurrence that: · results in death · is life threatening · results in persistent or significant disability / incapacity · requires in-patient hospitalization · prolongation of existing hospitalization · is a congenital anomaly / birth defect in the offspring of a study subject · In addition, important medical events that may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above should be considered serious. (Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization.) For each serious adverse event the investigator becomes aware of, please fill in a Serious Adverse Event(SAE) report and fax it to GSK Biologicals Study Contact for SAE reporting within 24 hours. 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

Trefwoorden

Versies (6)
  1. 04-02-19 04-02-19 -
  2. 07-02-19 07-02-19 -
  3. 10-02-19 10-02-19 -
  4. 12-02-19 12-02-19 -
  5. 16-02-19 16-02-19 -
  6. 20-02-19 20-02-19 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

16 februari 2019

DOI

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Licentie

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

Engels

Solicited Adverse Events

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschrijving

Date of Visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Solicited Adverse Events
Beschrijving

Solicited Adverse Events

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Beschrijving

If any of these adverse events meets the protocol definition of serious, please complete a Serious Adverse Event report and fax to GSK Biologicals Study Contact for SAE reporting within 24 hours. If "yes" is ticked, please tick No/Yes for each symptom. If Yes is ticked, please complete all items.

Datatype

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0877248
Solicited Adverse Events Record - Local Symptoms
Beschrijving

Solicited Adverse Events Record - Local Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0042196
Symptom Occurrence
Beschrijving

Applies to every single local symptom and should be filled out for each one. If a symptom is ticked, all items hereafter shold be filled out

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C2745955
Local Symptom
Beschrijving

Local Symptom

Datatype

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Study Day
Beschrijving

To be filled out for each day

Datatype

integer

Alias
UMLS CUI [1]
C2826182
Intensity
Beschrijving

Intensity: 0 / 1 / 2 / 3, if pain is ticked if pain occurred INTENSITY FOR NON-SOLICITED SYMPTOMS 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities (In adults/ adolescents, such an adverse event would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy).

Datatype

integer

Alias
UMLS CUI [1]
C0518690
Size
Beschrijving

Size in mm, if redness, swelling or ecchymosis occurred

Datatype

integer

Maateenheden
  • mm
Alias
UMLS CUI [1]
C0449453
mm
Ongoing after Day 6?
Beschrijving

Ongoing Symptom

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of Last Day of Symptoms
Beschrijving

if ongoing after Day 6

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Solicited Adverse Events - General Symptoms
Beschrijving

Solicited Adverse Events - General Symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Has the subject experienced any of the following signs/symptoms during the solicited period?
Beschrijving

If yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items.

Datatype

text

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0877248
Solicited Adverse Events Record - General Symptoms
Beschrijving

Solicited Adverse Events Record - General Symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Symptom Occurrence
Beschrijving

Applies to every single local symptom and should be filled out for each one. If a symptom is ticked, all items hereafter shold be filled out

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C2745955
General Symptom
Beschrijving

arthralgia = joint pain

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C1556354
Study Day
Beschrijving

To be filled out for each day

Datatype

integer

Alias
UMLS CUI [1]
C2826182
Intensity
Beschrijving

Intensity: 0 / 1 / 2 / 3 INTENSITY FOR NON-SOLICITED SYMPTOMS 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities (In adults/ adolescents, such an adverse event would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy).

Datatype

integer

Ongoing after Day 6?
Beschrijving

Ongoing Symptom

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of Last Day of Symptoms
Beschrijving

Date of Last Day of Symptoms

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Causality?
Beschrijving

Causality

Datatype

boolean

Alias
UMLS CUI [1]
C0015127
Solicited Adverse Events - Fever
Beschrijving

Solicited Adverse Events - Fever

Fever
Beschrijving

Fever: Axillary > 37.5°C Oral > 37.5°C Rectal > 38° C

Datatype

boolean

Alias
UMLS CUI [1]
C0015967
Fever Measurement Route
Beschrijving

If fever occurred oral is preferred

Datatype

text

Alias
UMLS CUI [1,1]
C0449687
UMLS CUI [1,2]
C0015967
Study Day
Beschrijving

To be filled out for each day

Datatype

integer

Alias
UMLS CUI [1]
C2826182
Body Temperature
Beschrijving

Body Temperature

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature not Taken
Beschrijving

Temperature not Taken

Datatype

boolean

Alias
UMLS CUI [1,1]
C0039476
UMLS CUI [1,2]
C0437722
Ongoing after Day 6?
Beschrijving

Ongoing Symptom

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of Last Day of Symptoms
Beschrijving

Date of Last Day of Symptoms

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Causality?
Beschrijving

Causality

Datatype

boolean

Alias
UMLS CUI [1]
C0015127
Unsolicited Adverse Events
Beschrijving

Unsolicited Adverse Events

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0042196
Has the subject experienced any serious or non-serious unsolicited adverse events from Visit 1 to Visit 2?
Beschrijving

If yes, Fill in the Non-Serious Adverse Event section or Serious Adverse Event report, as appropriate.

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0042196
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Similar models

Solicited Adverse Events

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Solicited Adverse Events
C1457887 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C1457887 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Solicited Adverse Events
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Solicited Adverse Events Record - Local Symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Symptom Occurrence
Item
Symptom Occurrence
boolean
C1457887 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Item
Local Symptom
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local Symptom
Code List
Local Symptom
CL Item
Redness (RE)
CL Item
Swelling (SW)
CL Item
Ecchymosis (EC)
CL Item
Pain (PA)
Item
Study Day
integer
C2826182 (UMLS CUI [1])
Study Day
Code List
Study Day
CL Item
Day 0 (0)
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
Item
Intensity
integer
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Size
Item
Size
integer
C0449453 (UMLS CUI [1])
Ongoing Symptom
Item
Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Date of Last Day of Symptoms
Item
Date of Last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
Solicited Adverse Events - General Symptoms
C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C0159028 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Solicited Adverse Events - General Symptoms
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Solicited Adverse Events Record - General Symptoms
C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Symptom Occurrence
Item
Symptom Occurrence
boolean
C1457887 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Item
General Symptom
text
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C1556354 (UMLS CUI [1,3])
General Symptom
Code List
General Symptom
CL Item
Fatigue (FA)
CL Item
Headache (HE)
CL Item
Muscle Ache (MH)
CL Item
Shivering (SH)
CL Item
Arthralgia (AR)
Item
Study Day
integer
C2826182 (UMLS CUI [1])
Study Day
Code List
Study Day
CL Item
Day 0 (0)
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
Item
Intensity
integer
Intensity
Code List
Intensity
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Ongoing Symptom
Item
Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Date of Last Day of Symptoms
Item
Date of Last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
Item Group
Solicited Adverse Events - Fever
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Item
Fever Measurement Route
text
C0449687 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Fever Measurement Route
Code List
Fever Measurement Route
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
Item
Study Day
integer
C2826182 (UMLS CUI [1])
Study Day
Code List
Study Day
CL Item
Day 0 (0)
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
Body Temperature
Item
Body Temperature
float
C0005903 (UMLS CUI [1])
Temperature not Taken
Item
Temperature not Taken
boolean
C0039476 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Ongoing Symptom
Item
Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Date of Last Day of Symptoms
Item
Date of Last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
Item Group
Unsolicited Adverse Events
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events from Visit 1 to Visit 2?
text
C0877248 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Unsolicited Adverse Events
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events from Visit 1 to Visit 2?
CL Item
Information not available (U)
CL Item
No vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
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