ID
36657
Descripción
Study ID: 107191 Clinical Study ID: 107191 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 FluarixTM (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years. Patient Level Data: NA Clinicaltrials.gov Identifier: NA EudraCT Number: 2006-000939-97 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A 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"
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
29 de mayo de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
Comentarios del modelo :
Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.
Comentarios de grupo de elementos para :
Comentarios del elemento para :
Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.
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
If main reason for non-participation was a (serious) adverse event.
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
If main reason for non-participation was an other reason.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Descripción
If main reason for non-participation was that 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
If subject experienced any serious adverse events since the phone contact on day 30 (FLU-LD-001).
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])