ID
35164
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)
- 04-02-19 04-02-19 -
- 07-02-19 07-02-19 -
- 10-02-19 10-02-19 -
- 12-02-19 12-02-19 -
- 16-02-19 16-02-19 -
- 20-02-19 20-02-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
20 februari 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373
Solicited Adverse Events
- StudyEvent: ODM
Beschrijving
Solicited Adverse Events
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
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
Beschrijving
Solicited Adverse Events Record - Local Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0042196
Beschrijving
Local Symptom
Datatype
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Beschrijving
Applies to every single local symptom and should be filled out for each one. If a symptom occurred, all items hereafter should be filled out
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2745955
Beschrijving
To be filled out for each day
Datatype
integer
Alias
- UMLS CUI [1]
- C2826182
Beschrijving
If pain occurred Pain at injection site 0: Absent 1: Painful on touch 2: Painful when limb is moved 3: Pain that prevents normal activity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0030193
Beschrijving
Size in mm, if redness, swelling or ecchymosis occurred
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1]
- C0449453
Beschrijving
Ongoing Symptom
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Beschrijving
if ongoing after Day 6
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Beschrijving
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Beschrijving
Solicited Adverse Events Record - General Symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Beschrijving
arthralgia = joint pain
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C1556354
Beschrijving
Applies to every single general 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
Beschrijving
To be filled out for each day
Datatype
integer
Alias
- UMLS CUI [1]
- C2826182
Beschrijving
0: Normal 1: Symptoms that are easily tolerated 2: Symptoms that interfere with normal activity 3: Symptoms that prevent normal activity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0159028
Beschrijving
Ongoing Symptom
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
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
Beschrijving
Causality
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015127
Beschrijving
Solicited Adverse Events - Fever
Beschrijving
Fever: Axillary > 37.5°C Oral > 37.5°C Rectal > 38° C
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
If fever occurred oral is preferred
Datatype
text
Alias
- UMLS CUI [1,1]
- C0449687
- UMLS CUI [1,2]
- C0015967
Beschrijving
To be filled out for each day
Datatype
integer
Alias
- UMLS CUI [1]
- C2826182
Beschrijving
Body Temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Temperature not Taken
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0039476
- UMLS CUI [1,2]
- C0437722
Beschrijving
Ongoing Symptom
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
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
Beschrijving
Causality
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015127
Beschrijving
Unsolicited Adverse Events
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0042196
Similar models
Solicited Adverse Events
- StudyEvent: ODM
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C2745955 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0159028 (UMLS CUI [1,2])
C1556354 (UMLS CUI [1,3])
C2745955 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0015967 (UMLS CUI [1,2])
C0437722 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0042196 (UMLS CUI-2)
C0042196 (UMLS CUI [1,2])