ID
34958
Beskrivning
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 this form is to document any non-serious adverse events, the subject has experienced during the study. It should be filled out at each visit/contact. All AEs occurring within 30 days following administration of the dose of vaccine must be recorded on the Adverse Event form in the subject's CRF, irrespective of intensity or whether or not they are considered vaccination-related. 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
Länk
https://clinicaltrials.gov/ct2/show/NCT00321373
Nyckelord
Versioner (3)
- 2019-02-05 2019-02-05 -
- 2019-02-07 2019-02-07 -
- 2019-02-08 2019-02-08 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
5 februari 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373
Non-Serious Adverse Events
- StudyEvent: ODM
Beskrivning
Non-serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Beskrivning
(Please report all serious adverse events only on the Serious Adverse Event (SAE) report). If yes, please complte the following table.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1518404
Beskrivning
Non-Serious Adverse Event Record
Alias
- UMLS CUI-1
- C1518404
Beskrivning
Description
Datatyp
text
Alias
- UMLS CUI [1]
- C0678257
Beskrivning
Administration Site
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Beskrivning
Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0808070
Beskrivning
NSAE Started Immediately
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1518404
- UMLS CUI [1,3]
- C0205253
Beskrivning
End date
Datatyp
date
Alias
- UMLS CUI [1]
- C0806020
Beskrivning
Maximum Intensity
Datatyp
text
Alias
- UMLS CUI [1]
- C1710066
Beskrivning
Relationship to Investigational Products
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
Outcome
Datatyp
integer
Alias
- UMLS CUI [1]
- C1705586
Similar models
Non-Serious Adverse Events
- StudyEvent: ODM
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,2])
C0205253 (UMLS CUI [1,3])
(Comment:en)
(Comment:en)
(Comment:en)
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)