ID
34958
Beschreibung
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
Stichworte
Versionen (3)
- 05.02.19 05.02.19 -
- 07.02.19 07.02.19 -
- 08.02.19 08.02.19 - Sarah Riepenhausen
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
5. Februar 2019
DOI
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Lizenz
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
Beschreibung
Non-serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Beschreibung
(Please report all serious adverse events only on the Serious Adverse Event (SAE) report). If yes, please complte the following table.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1518404
Beschreibung
Non-Serious Adverse Event Record
Alias
- UMLS CUI-1
- C1518404
Beschreibung
Description
Datentyp
text
Alias
- UMLS CUI [1]
- C0678257
Beschreibung
Administration Site
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Beschreibung
Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
NSAE Started Immediately
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1518404
- UMLS CUI [1,3]
- C0205253
Beschreibung
End date
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Maximum Intensity
Datentyp
text
Alias
- UMLS CUI [1]
- C1710066
Beschreibung
Relationship to Investigational Products
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschreibung
Outcome
Datentyp
integer
Alias
- UMLS CUI [1]
- C1705586
Ähnliche Modelle
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)