ID

35021

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 conclude the study. It should be filled out at the phone contact and rechecked at visit 3. 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)
  1. 08.02.19 08.02.19 -
  2. 10.02.19 10.02.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. Februar 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373

Englisch

Study Conclusion

1 Formulare  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Assessment Date
Beschreibung

Assessment Date

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Occurence of SAE
Beschreibung

Occurence of SAE

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2745955
Did the subject experience any Serious Adverse Event?
Beschreibung

Occurence of Serious Adverse Event

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2745955
Specify total number of SAE's
Beschreibung

If any SAE occurred

Datentyp

integer

Elimination Criteria
Beschreibung

Elimination Criteria

Alias
UMLS CUI-1
C0680251
Did any elimination criteria become applicable?
Beschreibung

Elimination Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Specify
Beschreibung

If any elimination criteria become applicable

Datentyp

text

Subject Withdrawal
Beschreibung

Subject Withdrawal

Alias
UMLS CUI-1
C0422727
Was the subject withdrawn from the study?
Beschreibung

Study Withdrawal

Datentyp

integer

Alias
UMLS CUI [1]
C0422727
Major reason for withdrawal
Beschreibung

If subject was withdrawn from the study Tick one box only

Datentyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Please specify SAE No.
Beschreibung

Applies If SAE was the major reason for withdrawal Please complete and submit SAE report

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Please specify AE No.
Beschreibung

Applies if non-serious adverse event was major reason for withdrawal Please complete Non-serious Adverse Event section

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Solicited AE code
Beschreibung

Applies if non-serious adverse event was major reason for withdrawal

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0805701
Protocol violation, please specify
Beschreibung

If protocol violation was major reason for withdrawal

Datentyp

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C2348235
Other, please specify
Beschreibung

If there was another major reason for withdrawal

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Who made the Decision?
Beschreibung

Decision

Datentyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
Date of last contact
Beschreibung

Date of Last Contact

Datentyp

date

Alias
UMLS CUI [1]
C0805839
Was the subject in good condition at date of last contact?
Beschreibung

If no, please give details in adverse events section

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0805839
UMLS CUI [1,2]
C1142435
Investigators Signature
Beschreibung

Investigators Signature

Alias
UMLS CUI-1
C2346576
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Beschreibung

Investigator's Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Printed Investigator's name
Beschreibung

Investigators Name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Study Conclusion

1 Formulare
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Occurence of SAE
C1519255 (UMLS CUI-1)
C2745955 (UMLS CUI-2)
Occurence of Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event?
integer
C1519255 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Number of SAE's
Item
Specify total number of SAE's
integer
Item Group
Elimination Criteria
C0680251 (UMLS CUI-1)
Elimination Criteria
Item
Did any elimination criteria become applicable?
boolean
C0680251 (UMLS CUI [1])
Elimination Criteria Specification
Item
Specify
text
Item Group
Subject Withdrawal
C0422727 (UMLS CUI-1)
Study Withdrawal
Item
Was the subject withdrawn from the study?
integer
C0422727 (UMLS CUI [1])
Item
Major reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason for Study Withdrawal
Code List
Major reason for withdrawal
CL Item
Serious Adverse Event (SAE)
CL Item
Non-Serious Adverse Event (AEX)
CL Item
Protocol Violation Specify (PTV)
CL Item
Consent withdrawal, not due to an adverse event (CWS)
CL Item
Migrated/moved from the study area (MIG)
CL Item
Lost to follow-up (LFU)
CL Item
Other (OTH)
SAE No.
Item
Please specify SAE No.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE No.
Item
Please specify AE No.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Solicited AE Code
Item
Solicited AE code
integer
C1518404 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Protocol Violation Specification
Item
Protocol violation, please specify
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Other Specification
Item
Other, please specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Who made the Decision?
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Decision
Code List
Who made the Decision?
CL Item
Investigator (I)
CL Item
Subject (S)
Date of Last Contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Subjects Condition at Last Contact
Item
Was the subject in good condition at date of last contact?
boolean
C0805839 (UMLS CUI [1,1])
C1142435 (UMLS CUI [1,2])
Item Group
Investigators Signature
C2346576 (UMLS CUI-1)
Investigator's Signature
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Investigators Name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video