ID
34933
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. 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
4 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
If redness, swelling or ecchymosis is ticked, provide size in mm. If pain is ticked, provide intensity from 0-3.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Descripción
Provide size/intensity of pain
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
Descripción
Provide size/intensity of pain
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
Descripción
Provide size/intensity of pain
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
Descripción
Provide size/intensity of pain
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
Descripción
Provide size/intensity of pain
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
Descripción
Provide size/intensity of pain
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
Descripción
Provide size/intensity of pain
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
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
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
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. arthralgia = joint pain
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0159028
Descripción
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Descripción
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Descripción
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Descripción
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Descripción
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Descripción
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Descripción
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
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
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0015967
Descripción
If fever is ticked
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0449687
- UMLS CUI [1,2]
- C0015967
Descripción
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Descripción
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Descripción
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Descripción
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Descripción
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Descripción
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Descripción
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
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)
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)
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])
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])
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0042196 (UMLS CUI-2)
C0042196 (UMLS CUI [1,2])