ID

33517

Descrição

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

Palavras-chave

Versões (3)
  1. 11/12/2018 11/12/2018 -
  2. 05/06/2019 05/06/2019 -
  3. 06/06/2019 06/06/2019 - Sarah Riepenhausen
Titular dos direitos

GSK group of companies

Transferido a

11 de dezembro de 2018

DOI

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Licença

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)

Inglês

Visit 1: Eligibility Criteria

1 Formulários  
Administrative data
Descrição

Administrative data

Protocol Number
Descrição

Protocol Number

Tipo de dados

integer

Subject Number
Descrição

Subject Number

Tipo de dados

integer

Visit
Descrição

Visit

Tipo de dados

text

Eligibility Check
Descrição

Eligibility Check

Did the subject meet all the entry criteria?
Descrição

entry criteria met?

Tipo de dados

boolean

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

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

Tipo de dados

text

Inclusion Criteria
Descrição

Inclusion Criteria

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

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

Tipo de dados

integer

Exclusion Criteria
Descrição

Exclusion Criteria

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

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

Tipo de dados

text

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Similar models

Visit 1: Eligibility Criteria

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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