ID

33517

Beschrijving

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

Trefwoorden

Versies (3)
  1. 11-12-18 11-12-18 -
  2. 05-06-19 05-06-19 -
  3. 06-06-19 06-06-19 - Sarah Riepenhausen
Houder van rechten

GSK group of companies

Geüploaded op

11 december 2018

DOI

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Licentie

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)

Engels

Visit 1: Eligibility Criteria

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Protocol Number
Beschrijving

Protocol Number

Datatype

integer

Subject Number
Beschrijving

Subject Number

Datatype

integer

Visit
Beschrijving

Visit

Datatype

text

Eligibility Check
Beschrijving

Eligibility Check

Did the subject meet all the entry criteria?
Beschrijving

entry criteria met?

Datatype

boolean

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

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

Datatype

text

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

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

Datatype

integer

Exclusion Criteria
Beschrijving

Exclusion Criteria

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

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

Datatype

text

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Similar models

Visit 1: Eligibility Criteria

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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