ID
34989
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. 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
7 februari 2019
DOI
Voor een aanvraag inloggen.
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
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
Redness
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C2700396
Beschrijving
Swelling
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C2700396
Beschrijving
Ecchymosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013491
Beschrijving
Pain
Datatype
boolean
Alias
- UMLS CUI [1]
- C0030193
Beschrijving
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
Datatype
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
Beschrijving
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
Datatype
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
Beschrijving
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
Datatype
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
Beschrijving
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
Datatype
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
Beschrijving
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
Datatype
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
Beschrijving
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
Datatype
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
Beschrijving
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
Datatype
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
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
Fatigue
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015672
Beschrijving
Headache
Datatype
boolean
Alias
- UMLS CUI [1]
- C0018681
Beschrijving
Muscle Ache
Datatype
boolean
Alias
- UMLS CUI [1]
- C0231528
Beschrijving
Shivering
Datatype
boolean
Alias
- UMLS CUI [1]
- C0036973
Beschrijving
Arthralgie
Datatype
boolean
Alias
- UMLS CUI [1]
- C0003862
Beschrijving
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschrijving
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschrijving
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschrijving
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschrijving
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschrijving
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschrijving
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
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 is ticked oral is preferred
Datatype
text
Alias
- UMLS CUI [1,1]
- C0449687
- UMLS CUI [1,2]
- C0015967
Beschrijving
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschrijving
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschrijving
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschrijving
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschrijving
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschrijving
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschrijving
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschrijving
Day 0 not taken
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0437722
- UMLS CUI [1,2]
- C2826182
Beschrijving
Day 1 not taken
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0437722
- UMLS CUI [1,2]
- C2826182
Beschrijving
Day 2 not taken
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0437722
- UMLS CUI [1,2]
- C2826182
Beschrijving
Day 3 not taken
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0437722
- UMLS CUI [1,2]
- C2826182
Beschrijving
Day 4 not taken
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0437722
- UMLS CUI [1,2]
- C2826182
Beschrijving
Day 5 not taken
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0437722
- UMLS CUI [1,2]
- C2826182
Beschrijving
Day 6 not taken
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0437722
- UMLS CUI [1,2]
- C2826182
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)
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
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)
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0015967 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (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])