ID

36759

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 This study (Malaria-039 / NCT00323622 / GlaxoSmithKline Study ID 104297) is a two-year follow-up to Malaria-026 and consists of three clinic visits: Visit 1 / Informed Consent Visit at Visit 7 of Malaria-026 (i.e. 21 months post vaccine dose 1 in Malaria-026). Visit 2 / Interim Analysis 12 months +/- 1 month after Visit 1. Visit 3 / Final Analysis 24 months +/- 1 month after Visit 1. See https://clinicaltrials.gov/ct2/show/NCT00323622 This document is to be completed at Visit 1 (if consent is given).

Link

https://clinicaltrials.gov/ct2/show/NCT00323622

Palavras-chave

  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

6 de junho de 2019

DOI

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Licença

Creative Commons BY-NC 3.0

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Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039

Visit 1: Consent Form

  1. StudyEvent: ODM
    1. Visit 1: Consent Form
Administrative data
Descrição

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Descrição

Visit 1, Study month 21 (21 months post dose 1 in Malaria-026)

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Informed Consent
Descrição

Informed Consent

Alias
UMLS CUI-1
C0021430
I certify that written/thumb-printed Informed Consent has been obtained prior to any study procedure on the date below
Descrição

Informed Consent Date

Tipo de dados

date

Alias
UMLS CUI [1]
C2985782

Similar models

Visit 1: Consent Form

  1. StudyEvent: ODM
    1. Visit 1: Consent Form
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
I certify that written/thumb-printed Informed Consent has been obtained prior to any study procedure on the date below
date
C2985782 (UMLS CUI [1])

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