ID
35164
Descripción
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
Palabras clave
Versiones (6)
- 4/2/19 4/2/19 -
- 7/2/19 7/2/19 -
- 10/2/19 10/2/19 -
- 12/2/19 12/2/19 -
- 16/2/19 16/2/19 -
- 20/2/19 20/2/19 - Sarah Riepenhausen
Titular de derechos de autor
GlaxoSmithKline
Subido en
20 de febrero de 2019
DOI
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Licencia
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
Solicited Adverse Events
- StudyEvent: ODM
Descripción
Solicited Adverse Events
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C0877248
Descripción
Solicited Adverse Events Record - Local Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0042196
Descripción
Local Symptom
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Descripción
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
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2745955
Descripción
To be filled out for each day
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2826182
Descripción
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
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0030193
Descripción
Size in mm, if redness, swelling or ecchymosis occurred
Tipo de datos
integer
Unidades de medida
- mm
Alias
- UMLS CUI [1]
- C0449453
Descripción
Ongoing Symptom
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Descripción
if ongoing after Day 6
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Descripción
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Descripción
Solicited Adverse Events Record - General Symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Descripción
arthralgia = joint pain
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C1556354
Descripción
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
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2745955
Descripción
To be filled out for each day
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2826182
Descripción
0: Normal 1: Symptoms that are easily tolerated 2: Symptoms that interfere with normal activity 3: Symptoms that prevent normal activity
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0159028
Descripción
Ongoing Symptom
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Descripción
Date of Last Day of Symptoms
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Descripción
Causality
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0015127
Descripción
Solicited Adverse Events - Fever
Descripción
Fever: Axillary > 37.5°C Oral > 37.5°C Rectal > 38° C
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0015967
Descripción
If fever occurred oral is preferred
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0449687
- UMLS CUI [1,2]
- C0015967
Descripción
To be filled out for each day
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2826182
Descripción
Body Temperature
Tipo de datos
float
Unidades de medida
- °C
Alias
- UMLS CUI [1]
- C0005903
Descripción
Temperature not Taken
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0039476
- UMLS CUI [1,2]
- C0437722
Descripción
Ongoing Symptom
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Descripción
Date of Last Day of Symptoms
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Descripción
Causality
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0015127
Descripción
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])