ID
35006
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 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
Link
https://clinicaltrials.gov/ct2/show/NCT00321373
Trefwoorden
Versies (3)
- 05-02-19 05-02-19 -
- 07-02-19 07-02-19 -
- 08-02-19 08-02-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
8 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
Non-Serious Adverse Events
- StudyEvent: ODM
Beschrijving
Non-serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Beschrijving
(Please report all serious adverse events only on the Serious Adverse Event (SAE) report). If yes, please complte the following table.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1518404
Beschrijving
Non-Serious Adverse Event Record
Alias
- UMLS CUI-1
- C1518404
Beschrijving
AE No.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beschrijving
Description
Datatype
text
Alias
- UMLS CUI [1]
- C0678257
Beschrijving
Administration Site
Datatype
text
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
NSAE Started Immediately
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1518404
- UMLS CUI [1,3]
- C0205253
Beschrijving
End date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Maximum Intensity
Datatype
text
Alias
- UMLS CUI [1]
- C1710066
Beschrijving
Relationship to Investigational Products
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschrijving
Outcome
Datatype
integer
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
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Non-Serious Adverse Events
- StudyEvent: ODM
C0237753 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,2])
C0205253 (UMLS CUI [1,3])
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C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
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