ID

35862

Descrição

Study ID: 110028 Clinical Study ID: 110028 Study Title: Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00510874 https://clinicaltrials.gov/ct2/show/NCT00510874 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine Trade Name: Pumarix, Pandemrix Study Indication: Influenza This study consists of 6 Visits and one Telephone Contact: -Visit 1: Visit „Day 0“ -Visit 2: Visit „Day 7“, Contact Window: Day 6-8, Minimum Number of Days between Successive Visits: 6 -Visit 3: Visit „Day 21“: Contact Window: Day 19-23, Minimum Number of Days between Successive Visits: 12 -Visit 4: Visit „Day 28“: Contact Window: Day 26-30, Minimum Number of Days between Successive Visits: 6 -Visit 5: Visit „Day 42“: Contact Window: Day 38-46, Minimum Number of Days between Successive Visits: 12 -Telephone Contact „Day 84“: Contact Window: Day 80-88 -Visit 6: Visit „Day 182“: Contact Window: Day 167-197 The screening can take place up to 21 days prior to Visit 1. This document contains the Study conclusion form. It has to be filled in for the end of study.

Link

https://clinicaltrials.gov/ct2/show/NCT00510874

Palavras-chave

Versões (2)
  1. 25/03/2019 25/03/2019 -
  2. 29/03/2019 29/03/2019 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

29 de março de 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874

Inglês

Study conclusion

1 Formulários  
  1. StudyEvent: ODM
    1. Study conclusion
Administrative data
Descrição

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Visit date
Descrição

day month year

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Occurrence of serious adverse event
Descrição

Occurrence of serious adverse event

Alias
UMLS CUI-1
C1519255
Did the subject experience any Serious Adverse Event through "Day 42"/ during the study period?
Descrição

Serious Adverse Event

Tipo de dados

text

Alias
UMLS CUI [1]
C1519255
If subject experienced any SAE, please specify total number of SAE's
Descrição

SAE Number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Pregnancy information
Descrição

Pregnancy information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant through "Day 42"/during the study period?
Descrição

If you tick yes, please complete the Pregnancy notification form.

Tipo de dados

text

Alias
UMLS CUI [1]
C0032961
Elimination criteria
Descrição

Elimination criteria

Alias
UMLS CUI-1
C0680251
Did any elimination criteria become applicable through "Day 42"/during the study period?
Descrição

Elimination criteria

Tipo de dados

text

Alias
UMLS CUI [1]
C0680251
If any elimination criteria became applicable, please specify
Descrição

Elimination criteria, specification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1521902
Withdrawal from study
Descrição

Withdrawal from study

Alias
UMLS CUI-1
C2349954
UMLS CUI-2
C0008976
Was the subject withdrawn from the active phase/Follow-up phase?
Descrição

Withdrawal of subject

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0008976
If the subject was withdrawn, please tick the major reason for withdrawal
Descrição

If you tick SAE: Please complete and submit SAE report. If you tick AEX: Please complete Non-serious Adverse Event section.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1549995
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0008976
If you tick SAE as major reason for withdrawl, please specify SAE Number
Descrição

SAE Number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
If you tick AE as major reason for withdrawl, please specify AE Number OR solicited AE code
Descrição

AE Number/ solicited AE code

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0805701
If you tick protocol violation as major reason for withdrawl, please specify
Descrição

Protocol violation, specification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C2348235
If you tick other as major reason for withdrawl, please specify
Descrição

Other reason, specification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C2348235
Who made the decision?
Descrição

Decision taken

Tipo de dados

text

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

day month year

Tipo de dados

date

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

If you tick No, please give details in Adverse Events section

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
Investigator's Signature
Descrição

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's Signature
Descrição

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.

Tipo de dados

text

Alias
UMLS CUI [1]
C2346576
Printed Investigator's name
Descrição

Printed Investigator's name

Tipo de dados

text

Alias
UMLS CUI [1]
C2826892
Date of signature
Descrição

day month year

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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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)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Item Group
Occurrence of serious adverse event
C1519255 (UMLS CUI-1)
Item
Did the subject experience any Serious Adverse Event through "Day 42"/ during the study period?
text
C1519255 (UMLS CUI [1])
Serious Adverse Event
Code List
Did the subject experience any Serious Adverse Event through "Day 42"/ during the study period?
CL Item
No (N)
CL Item
Yes (Y)
SAE Number
Item
If subject experienced any SAE, please specify total number of SAE's
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item Group
Pregnancy information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant through "Day 42"/during the study period?
text
C0032961 (UMLS CUI [1])
Pregnancy
Code List
Did the subject become pregnant through "Day 42"/during the study period?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not Applicable (Male only). (NA)
Item Group
Elimination criteria
C0680251 (UMLS CUI-1)
Item
Did any elimination criteria become applicable through "Day 42"/during the study period?
text
C0680251 (UMLS CUI [1])
Elimination criteria
Code List
Did any elimination criteria become applicable through "Day 42"/during the study period?
CL Item
No (N)
CL Item
Yes (Y)
Elimination criteria, specification
Item
If any elimination criteria became applicable, please specify
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Withdrawal from study
C2349954 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Item
Was the subject withdrawn from the active phase/Follow-up phase?
text
C2349954 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Withdrawal of subject
Code List
Was the subject withdrawn from the active phase/Follow-up phase?
CL Item
No (N)
CL Item
Yes (Y)
Item
If the subject was withdrawn, please tick the major reason for withdrawal
text
C1549995 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Withdrawal of subject
Code List
If the subject was withdrawn, please tick the major reason for withdrawal
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Protocol violation (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 Number
Item
If you tick SAE as major reason for withdrawl, please specify SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number/ solicited AE code
Item
If you tick AE as major reason for withdrawl, please specify AE Number OR solicited AE code
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
Protocol violation, specification
Item
If you tick protocol violation as major reason for withdrawl, please specify
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Other reason, specification
Item
If you tick other as major reason for withdrawl, please specify
text
C3840932 (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 taken
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])
Item
Was the subject in good condition at date of last contact?
text
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Subject's condition
Code List
Was the subject in good condition at date of last contact?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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