ID
35178
Description
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 the reason for the subjects non-participation and if the subject has had any SAEs since the last contact. 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 Visit 1 and 2 are part of the study: "Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373"
Lien
https://clinicaltrials.gov/ct2/show/NCT00321373
Mots-clés
Versions (2)
- 22/02/2019 22/02/2019 -
- 29/05/2019 29/05/2019 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
22 février 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix EudraCT Number 2006-000939-97
Tracking Document
- StudyEvent: ODM
Description
Reason for Non Participation
Alias
- UMLS CUI-1
- C0558080
- UMLS CUI-2
- C0679823
- UMLS CUI-3
- C0392360
Description
Reason for Non Participation
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0558080
- UMLS CUI [1,2]
- C0679823
- UMLS CUI [1,3]
- C0392360
Description
If main reason for non-participation was that the subject was not eligible
Type de données
text
Alias
- UMLS CUI [1,1]
- C3242266
- UMLS CUI [1,2]
- C2348235
Description
Adverse Event or Serious Adverse Event Specification
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C2348235
Description
Other Specification
Type de données
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Description
Date the Subject Died
Type de données
date
Alias
- UMLS CUI [1]
- C1148348
Description
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Description
If yes, check the following items and check SAE forms have been submitted to GSK Biologicals.
Type de données
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
Number of SAEs
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Similar models
Tracking Document
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0679823 (UMLS CUI-2)
C0392360 (UMLS CUI-3)
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])