ID

42532

Description

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 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 ODM derived from https://clinicaltrials.gov/ct2/show/NCT00307021. A Phase II randomized, double-blind bridging study of the safety and immunogenicity of GlaxoSmithKline Plasmodium falciparum 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 vaccination schedule in children aged 18 months to 4 years living in Gabon. Clinical Visits: 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). Vaccine administration takes place during visits 2, 4, and 5 (Visit 2 = Dose 1; Visit 4 = Dose 2; Visit 5 = Dose 3). Field-worker Visits: During the double-blind phase, clinical visits are accompanied by daily field-worker visits subsequent to each vaccine administration visit. Additional field-worker visits also take place during months 4 to 13 of the single-blind phase. The check for study continuation should be performed and documented at all clinical visits subsequent to the screening visit (i.e., visits 2, 3, 4, 5, 6, and 7). Reasons for withdrawal only need to be specified if the subject has not returned. Note that informed consent has to be obtained prior to any study procedure.

Link

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

Keywords

Versions (1)
  1. 8/24/21 8/24/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 24, 2021

DOI

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License

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

English

Check for Study Continuation

1 forms  
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Visit number
Description

Visit number

Data type

integer

Alias
UMLS CUI [1]
C1549755
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Check for Study Continuation
Description

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject return for the above-specified visit?
Description

If yes, please complete the forms for this visit. If no, please complete this form and skip the other forms for this visit.

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
If no, same reason and decision as previous visit?
Description

Only possible to tick at visits 3, 4, 5, 6, or 7. For visit 2 OR if withdrawal reason and justification are not equal to the previous visit, please fill in the following question in this form.

Data type

boolean

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C0205225
UMLS CUI [1,5]
C2127115
UMLS CUI [2,1]
C0457454
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0679006
UMLS CUI [2,4]
C2127115
If no, please tick the ONE most appropriate reason and skip the following forms of this visit.
Description

Discontinuation clinical trial primary reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C0205225
If serious adverse event [SAE], please specify SAE N°.
Description

If serious adverse event [SAE], please also complete the SAE form.

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1521902
If non-serious adverse event [AEX], please specify AE N°.
Description

If non-serious adverse event [AEX], please also complete the non-serious adverse event section.

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1521902
If other [OTH], please specify (e.g.: consent withdrawal, protocol violation, …).
Description

Discontinuation clinical trial primary reason to specify | consent withdrawal | protocol violation

Data type

text

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C0205225
UMLS CUI [1,5]
C1521902
UMLS CUI [2]
C1707492
UMLS CUI [3]
C1709750
Please tick who made the decision.
Description

Discontinuation clinical trial decision maker

Data type

text

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0679006
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Similar models

Check for Study Continuation

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
clinical visit 2 (2)
CL Item
clinical visit 3 (3)
CL Item
clinical visit 4 (4)
CL Item
clinical visit 5 (5)
CL Item
clinical visit 6 (6)
CL Item
clinical visit 7 (7)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Visit continuation status clinical trial
Item
Did the subject return for the above-specified visit?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Discontinuation clinical trial primary reason justification and decision unchanged from previous visit
Item
If no, same reason and decision as previous visit?
boolean
C0457454 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205225 (UMLS CUI [1,4])
C2127115 (UMLS CUI [1,5])
C0457454 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0679006 (UMLS CUI [2,3])
C2127115 (UMLS CUI [2,4])
Item
If no, please tick the ONE most appropriate reason and skip the following forms of this visit.
text
C0457454 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205225 (UMLS CUI [1,4])
Patient withdrawn from trial, reason justification, primary
Code List
If no, please tick the ONE most appropriate reason and skip the following forms of this visit.
CL Item
Serious adverse event ([SAE])
CL Item
Non-serious Adverse Event ([AEX])
CL Item
Other ([OTH])
Serious adverse event number to specify
Item
If serious adverse event [SAE], please specify SAE N°.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Non-serious adverse event number to specify
Item
If non-serious adverse event [AEX], please specify AE N°.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Discontinuation clinical trial primary reason to specify | consent withdrawal | protocol violation
Item
If other [OTH], please specify (e.g.: consent withdrawal, protocol violation, …).
text
C0457454 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205225 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
C1707492 (UMLS CUI [2])
C1709750 (UMLS CUI [3])
Item
Please tick who made the decision.
text
C0457454 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Withdrawal decision maker
Code List
Please tick who made the decision.
CL Item
Investigator  ([I])
CL Item
Parents/Guardians ([P])
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