ID

35159

Beschreibung

Study ID: 107495 Clinical Study ID: 107495 Study Title: A phase II, open, randomized study in adults aged between 18 and 60 years designed to evaluate the reactogenicity and immunogenicity of a 1- and 2-dose prime-boost concept of pandemic monovalent (H5N1) influenza vaccine (split virus formulation) adjuvanted with AS03, administered according to different vaccination schedules. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00430521 https://clinicaltrials.gov/ct2/show/NCT00430521 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Pandemic influenza vaccine (GSK1119711A)-formulation 1, Pandemic influenza vaccine (GSK1119711A)-formulation 2 Trade Name: N/A Study Indication: Influenza There are 4 workbooks (WB): WB 1: Protocol 107495, (H5N1-012), Groups: VT/VT/6Mo, VT/IN/6Mo WB 2: Protocol 107495, (H5N1-012), Groups: VT/VT/12Mo, VT/IN/12Mo WB 3: Protocol 107495 (H5N1-012) GROUPS: 2VT/VT/6MO, 2VT/IN/6MO WB 4: Protocol 107495 (H5N1-012) Groups: 2VT/VT/12Mo, 2VT/IN/12Mo Every Workbook has the following visits: Visit Day 0 (Screening, Dose 1), Visit Day 21, Visit Month 6, Visit Month 12 and Visit Month 18. After Month 6 (+30 days, if applicable) and Month 12 (+30 days, if applicable) there is a Core Analysis section, followed by a final study conclusion after Month 18. Workbook 1 schedules a vaccination at screening and Month 6 each, Workbook 2 at Screening and Month 12. 30 days after the first vaccination there is an additional telephone contact. After the second vaccination additional visits/contacts are necessary in both workbooks: a visit at Month 6/12 + 7 and 21 days and a telephone contact on Month 6/12 + 30 days. Workbook 3 schedules a vaccination at screening, Day 21 and Month 6 and Workbook 4 at screening, Day 21 and Month 12. After the second vaccination there is an additional visit on Day 42 and a telephone contact on day 51. After the third vaccination there are additional visits/contacts: visits at Month 6/12 + 7 and 21 days and a telephone contact at Month 6/12 + 30 days. After Month 6 (+30 days, if applicable) and Month 12 (+30 days, if applicable) there is a Core Analysis section. This document contains the Study conclusion/Core analysis conclusion form. For all WB's it has to be filled in for the end of study. Additionally it has to be filled in for: 1 = Core Analysis 1 Month 6 (WB2+4) 2 = Core Anaylsis 1 Month 6 + 30 days (WB1+3) 3 = Core Analysis 2 Month 12 (WB1+3) 4 = Core Analysis 2 Month 12 + 30 days (WB2+4)

Link

https://clinicaltrials.gov/ct2/show/NCT00430521

Stichworte

Versionen (1)
  1. 20.02.19 20.02.19 -
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GlaxoSmithKline

Hochgeladen am

20. Februar 2019

DOI

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Creative Commons BY-NC 3.0
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Evaluation of reactogenicity and immunogenicity of pandemic monovalent (H5N1) influenza vaccine in adults, NCT00430521

Englisch

Study/Core analysis conclusion

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Workbook Number
Beschreibung

Workbook Number

Datentyp

integer

Alias
UMLS CUI [1]
C2986015
Visit type
Beschreibung

Core Analysis 1: After 6 Months for WBs 2 and 4 and after 6 Months + 30 days for WBs 1 and 3. Core Analysis 2: After 12 Months for WBs 1 and 3 and after 12 Months + 30 days for WBs 2 and 4.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Occurrence of serious adverse event
Beschreibung

Occurrence of serious adverse event

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2745955
Did the subject experience any Serious Adverse Event between vaccination and the following visit?
Beschreibung

Time specification: For WB1+3: 1) between Visit Day 0 and Telephone Contact Month 6 + 30 days, 2) between Telephone Contact Month 6 + 30 days and Visit Month 12, 3) between Visit Month 12 and Visit Month 18 For WB2+4: 1) between Visit Day 0 and Visit Month 6, 2) between Visit Month 6 and Telephone contact Month 12 + 30 days, 3) between Telephone contact Month 12 + 30 days and Visit Month 18

Datentyp

text

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C1519255
If SAE occurs during study, please specify total number of SAE's
Beschreibung

Number of SAE

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Pregnancy information
Beschreibung

Pregnancy information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant between vaccination and following visit?
Beschreibung

If you tick yes, complete the pregnancy notification form. Time specification: For WB1+3: 1) between Visit Day 0 and Telephone Contact Month 6 + 30 days, 2) between Telephone Contact Month 6 + 30 days and Visit Month 12, 3) between Visit Month 12 and Visit Month 18 For WB2+4: 1) between Visit Day 0 and Visit Month 6, 2) between Visit Month 6 and Telephone contact Month 12 + 30 days, 3) between Telephone contact Month 12 + 30 days and Visit Month 18

Datentyp

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0008976
Elimination criteria
Beschreibung

Elimination criteria

Alias
UMLS CUI-1
C0680251
Did any elimination criteria become applicable between vaccination and following visit?
Beschreibung

Time specification: For WB1+3: 1) between Visit Day 0 and Telephone Contact Month 6 + 30 days, 2) between Telephone Contact Month 6 + 30 days and Visit Month 12, 3) between Visit Month 12 and Visit Month 18 For WB2+4: 1) between Visit Day 0 and Visit Month 6, 2) between Visit Month 6 and Telephone contact Month 12 + 30 days, 3) between Telephone contact Month 12 + 30 days and Visit Month 18

Datentyp

text

Alias
UMLS CUI [1]
C0680251
If elimination criteria become applicable, please specify
Beschreibung

Elimination criteria, specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348235
Withdraw from study
Beschreibung

Withdraw from study

Alias
UMLS CUI-1
C2349954
UMLS CUI-2
C0008976
Was the subject withdrawn between vaccination and following visit?
Beschreibung

Time specification: For WB1+3: 1) between Visit Day 0 and Telephone Contact Month 6 + 30 days, 2) between Telephone Contact Month 6 + 30 days and Visit Month 12, 3) between Visit Month 12 and Visit Month 18 For WB2+4: 1) between Visit Day 0 and Visit Month 6, 2) between Visit Month 6 and Telephone contact Month 12 + 30 days, 3) between Telephone contact Month 12 + 30 days and Visit Month 18 "A subject is withdrawn from the CORE analysis 1/2 if he/she did not come for the CORE analysis 1/2 timepoint visit."

Datentyp

text

Alias
UMLS CUI [1]
C0422727
If subject was withdrawn, tick the major reason for withdrawal
Beschreibung

(tick one box only). If you tick SAE, please complete and submit SAE report. If you tick AEX please complete Non-serious Adverse Event section.

Datentyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0566251
SAE Number
Beschreibung

Fill in if you ticked SAE as reason for withdrawal.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
AE Number
Beschreibung

Fill in if you ticked AE as reason for withdrawal.

Datentyp

integer

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

Fill in if you ticked AE as reason for withdrawal.

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1517001
UMLS CUI [1,3]
C0805701
Protocol violation, specification
Beschreibung

Fill in if you ticked Protocol violation as reason for withdrawal.

Datentyp

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C2348235
Other Reason for withdrawal
Beschreibung

Fill in if you ticked other as reason for withdrawal.

Datentyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C2348235
Who made the decision?
Beschreibung

Decision maker

Datentyp

text

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

day month year

Datentyp

date

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

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C1142435
Investigator's signature
Beschreibung

Investigator's signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Beschreibung

"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."

Datentyp

text

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

Printed Investigator's name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Date of signature
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Study/Core analysis conclusion

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Workbook Number
integer
C2986015 (UMLS CUI [1])
Workbook Number
Code List
Workbook Number
CL Item
WB1 (1)
CL Item
WB2 (2)
CL Item
WB3 (3)
CL Item
WB4 (4)
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Core Analysis 1 (1)
CL Item
Core Anaylsis 2 (2)
CL Item
End of study (all WBs) (3)
Item Group
Occurrence of serious adverse event
C1519255 (UMLS CUI-1)
C2745955 (UMLS CUI-2)
Item
Did the subject experience any Serious Adverse Event between vaccination and the following visit?
text
C2745955 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Occurrence of SAE
Code List
Did the subject experience any Serious Adverse Event between vaccination and the following visit?
CL Item
No (N)
CL Item
Yes (Y)
Number of SAE
Item
If SAE occurs during study, please specify total number of SAE's
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Pregnancy information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant between vaccination and following visit?
text
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Pregnancy during study
Code List
Did the subject become pregnant between vaccination and following visit?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not Applicable (not of childbearing potential or male) (NA)
Item Group
Elimination criteria
C0680251 (UMLS CUI-1)
Item
Did any elimination criteria become applicable between vaccination and following visit?
text
C0680251 (UMLS CUI [1])
Elimination criteria
Code List
Did any elimination criteria become applicable between vaccination and following visit?
CL Item
No (N)
CL Item
Yes (Y)
Elimination criteria, specification
Item
If elimination criteria become applicable, please specify
text
C0680251 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Withdraw from study
C2349954 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Item
Was the subject withdrawn between vaccination and following visit?
text
C0422727 (UMLS CUI [1])
Subject's withdrawn
Code List
Was the subject withdrawn between vaccination and following visit?
CL Item
No (N)
CL Item
Yes (Y)
Item
If subject was withdrawn, tick the major reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reason for withdrawal
Code List
If subject was withdrawn, 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
SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Item
AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Solicited AE code
Item
Solicited AE code
text
C0877248 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Protocol violation, specification
Item
Protocol violation, specification
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Other Reason for withdrawal
Item
Other Reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Who made the decision?
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Decision maker
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
C0332158 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C1142435 (UMLS CUI [1,3])
Subject's condition at last contact
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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