ID

35021

Descrição

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

Palavras-chave

Versões (2)
  1. 08/02/2019 08/02/2019 -
  2. 10/02/2019 10/02/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

10 de fevereiro de 2019

DOI

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Licença

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

Inglês

Study Conclusion

1 Formulários  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Assessment Date
Descrição

Assessment Date

Tipo de dados

date

Alias
UMLS CUI [1]
C2985720
Subject Number
Descrição

Subject Number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Occurence of SAE
Descrição

Occurence of SAE

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

Occurence of Serious Adverse Event

Tipo de dados

integer

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

If any SAE occurred

Tipo de dados

integer

Elimination Criteria
Descrição

Elimination Criteria

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

Elimination Criteria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0680251
Specify
Descrição

If any elimination criteria become applicable

Tipo de dados

text

Subject Withdrawal
Descrição

Subject Withdrawal

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Was the subject withdrawn from the study?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

Study Withdrawal

Tipo de dados

integer

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

If subject was withdrawn from the study Tick one box only

Tipo de dados

text

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

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

Tipo de dados

integer

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

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

Tipo de dados

integer

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

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

Tipo de dados

integer

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

If protocol violation was major reason for withdrawal

Tipo de dados

text

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

If there was another major reason for withdrawal

Tipo de dados

text

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

Decision

Tipo de dados

text

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

Date of Last Contact

Tipo de dados

date

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

If no, please give details in adverse events section

Tipo de dados

boolean

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

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.
Descrição

Investigator's Signature

Tipo de dados

text

Alias
UMLS CUI [1]
C2346576
Date
Descrição

Date

Tipo de dados

date

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

Investigators Name

Tipo de dados

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Study Conclusion

1 Formulários
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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