ID
34934
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 his form is to document if returned for study continuation and should be filled out at visit 2. 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 (2)
- 04.02.19 04.02.19 -
- 06.02.19 06.02.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
4. 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
Study Continuation
- StudyEvent: ODM
Beschreibung
Check for Study Continuation
Alias
- UMLS CUI-1
- C0805733
- UMLS CUI-2
- C0008976
- UMLS CUI-3
- C0042210
Beschreibung
Study Continuation
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0008972
- UMLS CUI [1,2]
- C0805733
Beschreibung
Reason for Non-Continuation
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0566251
Beschreibung
If SAE was main reason for non-continuation PLease complete and submit SAE report
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beschreibung
Please complete the Non-Serious Adverse Event section
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C0805701
- UMLS CUI [2,3]
- C1521902
Beschreibung
e.g.: consent withdrawal, Protocol violation
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Beschreibung
Responsible for Decision
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1273518
- UMLS CUI [1,2]
- C0679006
Ähnliche Modelle
Study Continuation
- StudyEvent: ODM
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
C0805733 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
C1521902 (UMLS CUI [2,3])
C2348235 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])