ID

33517

Description

Study ID: 104297 Clinical Study ID: 104297 Study Title: An open study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A in Mozambican children aged 1 to 4 years at the time of first vaccine dose. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00323622 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: SB257049 Study Indication: Malaria

Keywords

Versions (3)
  1. 12/11/18 12/11/18 -
  2. 6/5/19 6/5/19 -
  3. 6/6/19 6/6/19 - Sarah Riepenhausen
Copyright Holder

GSK group of companies

Uploaded on

December 11, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Immunogenicity of malaria vaccine candidate in Mozambican children (1 to 4 y.o) - 104297 (Malaria039)

English

Visit 1: Eligibility Criteria

1 forms  
Administrative data
Description

Administrative data

Protocol Number
Description

Protocol Number

Data type

integer

Subject Number
Description

Subject Number

Data type

integer

Visit
Description

Visit

Data type

text

Eligibility Check
Description

Eligibility Check

Did the subject meet all the entry criteria?
Description

entry criteria met?

Data type

boolean

If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria.
Description

If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria.

Data type

text

Inclusion Criteria
Description

Inclusion Criteria

Tick all the boxes corresponding to any of the inclusion criteria the subject failed.
Description

Tick all the boxes corresponding to any of the inclusion criteria the subject failed.

Data type

integer

Exclusion Criteria
Description

Exclusion Criteria

Tick all the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
Description

Tick all the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Data type

text

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Similar models

Visit 1: Eligibility Criteria

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Protocol Number
Item
Protocol Number
integer
Subject Number
Item
Subject Number
integer
Item
Visit
text
Visit
Code List
Visit
CL Item
Visit 1, Study month 21 (21 months post dose 1 in Malaria-026) (1)
Item Group
Eligibility Check
entry criteria met?
Item
Did the subject meet all the entry criteria?
boolean
If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria.
Item
If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria.
text
Item Group
Inclusion Criteria
Item
Tick all the boxes corresponding to any of the inclusion criteria the subject failed.
integer
Tick all the boxes corresponding to any of the inclusion criteria the subject failed.
Code List
Tick all the boxes corresponding to any of the inclusion criteria the subject failed.
CL Item
Completion of Visit 7, Month 21 of Malaria-026. (1)
CL Item
Written informed consent obtained from the parent(s) or guardian(s) of the subject. (2)
Item Group
Exclusion Criteria
Item
Tick all the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
text
Tick all the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
Code List
Tick all the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
CL Item
Planned use of any investigational or non-registered drug or vaccine during the study period. (1)
CL Item
Simultaneous participation in any other clinical trial. (2)
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