ID
35178
Descripción
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"
Link
https://clinicaltrials.gov/ct2/show/NCT00321373
Palabras clave
Versiones (2)
- 22/2/19 22/2/19 -
- 29/5/19 29/5/19 - Sarah Riepenhausen
Titular de derechos de autor
GlaxoSmithKline
Subido en
22 de febrero de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
Reason for Non Participation
Alias
- UMLS CUI-1
- C0558080
- UMLS CUI-2
- C0679823
- UMLS CUI-3
- C0392360
Descripción
Reason for Non Participation
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0558080
- UMLS CUI [1,2]
- C0679823
- UMLS CUI [1,3]
- C0392360
Descripción
If main reason for non-participation was that the subject was not eligible
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3242266
- UMLS CUI [1,2]
- C2348235
Descripción
Adverse Event or Serious Adverse Event Specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C2348235
Descripción
Other Specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Descripción
Date the Subject Died
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1148348
Descripción
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Descripción
If yes, check the following items and check SAE forms have been submitted to GSK Biologicals.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1519255
Descripción
Number of SAEs
Tipo de datos
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])