ID

41661

Beschreibung

Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 https://clinicaltrials.gov/ct2/show/NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). This form (Screening Conclusion) is to be filled out at Visit 1 (Day -28 to day 0).

Link

https://clinicaltrials.gov/ct2/show/NCT00307021

Stichworte

Versionen (2)
  1. 01.12.20 01.12.20 -
  2. 05.12.20 05.12.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. Dezember 2020

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021

Englisch

Screening Conclusion

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

Administrative Data

Alias
UMLS CUI-1
C1320722
Centre number
Beschreibung

Centre number

Datentyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Treatment number
Beschreibung

Treatment number

Datentyp

text

Alias
UMLS CUI [1]
C1522541
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Screening Conclusion
Beschreibung

Screening Conclusion

Alias
UMLS CUI-1
C1710477
UMLS CUI-2
C1707478
Did the subject experience any Serious Adverse Event during screening? (only SAE related to study participation or to a concurrent medication need to be considered and reported)
Beschreibung

SAE during screening

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C1710477
If yes, specify total number of SAEs
Beschreibung

Number of SAEs during screening

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C1710477
Is the subject a screening failure? (Was the subject withdrawn prior to randomization or first vaccination?)
Beschreibung

Screen failure (withdrawn prior to randomization or first vaccination)

Datentyp

text

Alias
UMLS CUI [1]
C1710476
UMLS CUI [2,1]
C0422727
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0034656
UMLS CUI [3,1]
C0422727
UMLS CUI [3,2]
C0332152
UMLS CUI [3,3]
C0205435
UMLS CUI [3,4]
C0042196
If yes, provide Major reason for failure (tick one box only)
Beschreibung

Major reason for screening failure

Datentyp

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C1542147
UMLS CUI [1,3]
C0566251
If protocol violation, please specify
Beschreibung

Reason for screening failure: protocol violation

Datentyp

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1709750
UMLS CUI [1,4]
C2348235
If SAE please specify SAE No.
Beschreibung

Reason for screening failure: SAE

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1519255
UMLS CUI [1,4]
C0237753
If other reason, please specify
Beschreibung

Other reason for screening failure

Datentyp

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C2348235
Who made the decision?
Beschreibung

Decision

Datentyp

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C1710476
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 dat below.

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Date of investigator's signature

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Printed Investigator's name
Beschreibung

Printed Investigator's name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

Screening Conclusion

1 Formulare
  1. StudyEvent: ODM
    1. Screening Conclusion
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Centre number
Item
Centre number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Treatment number
Item
Treatment number
text
C1522541 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Screening Conclusion
C1710477 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
Item
Did the subject experience any Serious Adverse Event during screening? (only SAE related to study participation or to a concurrent medication need to be considered and reported)
text
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
SAE during screening
Code List
Did the subject experience any Serious Adverse Event during screening? (only SAE related to study participation or to a concurrent medication need to be considered and reported)
CL Item
No (N)
CL Item
Yes, specify total number of SAEs (Y)
Number of SAEs during screening
Item
If yes, specify total number of SAEs
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C1710477 (UMLS CUI [1,4])
Item
Is the subject a screening failure? (Was the subject withdrawn prior to randomization or first vaccination?)
text
C1710476 (UMLS CUI [1])
C0422727 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0034656 (UMLS CUI [2,3])
C0422727 (UMLS CUI [3,1])
C0332152 (UMLS CUI [3,2])
C0205435 (UMLS CUI [3,3])
C0042196 (UMLS CUI [3,4])
Screen failure (withdrawn prior to randomization or first vaccination)
Code List
Is the subject a screening failure? (Was the subject withdrawn prior to randomization or first vaccination?)
CL Item
No (N)
CL Item
Yes, provide major reason for failure (Y)
Item
If yes, provide Major reason for failure (tick one box only)
text
C1710476 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Major reason for screening failure
Code List
If yes, provide Major reason for failure (tick one box only)
CL Item
Eligibility criteria not fulfilled (inclusion and exclusion criteria; please tick failing criteria on Eligibility form) (ELI)
CL Item
Protocol violation, please specify (PTV)
CL Item
Serious Adverse Event (please complete and submit SAE report and specify SAE No.) (SAE)
CL Item
Consent withdrawal / not willing to participate, not due to a serious adverse event (CWS)
CL Item
Migrated /moved from the study area (MIG)
CL Item
Lost to follow-up (LFU)
CL Item
Other, please specify (OTH)
Reason for screening failure: protocol violation
Item
If protocol violation, please specify
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1709750 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Reason for screening failure: SAE
Item
If SAE please specify SAE No.
integer
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Other reason for screening failure
Item
If other reason, please specify
text
C1710476 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Who made the decision?
text
C0679006 (UMLS CUI [1,1])
C1710476 (UMLS CUI [1,2])
Decision
Code List
Who made the decision?
CL Item
Investigator (I)
CL Item
Parents/Guardian (P)
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Date of investigator's signature
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
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