ID

33517

Descripción

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

Palabras clave

Versiones (3)
  1. 11/12/18 11/12/18 -
  2. 5/6/19 5/6/19 -
  3. 6/6/19 6/6/19 - Sarah Riepenhausen
Titular de derechos de autor

GSK group of companies

Subido en

11 de diciembre de 2018

DOI

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Licencia

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)

Inglés

Visit 1: Eligibility Criteria

1 formularios  
Administrative data
Descripción

Administrative data

Protocol Number
Descripción

Protocol Number

Tipo de datos

integer

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Visit
Descripción

Visit

Tipo de datos

text

Eligibility Check
Descripción

Eligibility Check

Did the subject meet all the entry criteria?
Descripción

entry criteria met?

Tipo de datos

boolean

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

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

Tipo de datos

text

Inclusion Criteria
Descripción

Inclusion Criteria

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

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

Tipo de datos

integer

Exclusion Criteria
Descripción

Exclusion Criteria

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

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

Tipo de datos

text

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Similar models

Visit 1: Eligibility Criteria

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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