ID

36760

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 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.

Link

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

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

6 de junio de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039

Inglés

Visit 1: Demographics

1 formularios  
  1. StudyEvent: ODM
    1. Visit 1: Demographics
Administrative data
Descripción

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Descripción

Previous Study: 257049/026 (Malaria-026). Subject number will be the same as in the previous study (long-term follow-up).

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Descripción

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

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Demographics
Descripción

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Descripción

Center number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Date of birth
Descripción

Date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Gender
Descripción

Gender

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
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Similar models

Visit 1: Demographics

1 formularios
  1. StudyEvent: ODM
    1. Visit 1: Demographics
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
Demographics
C1704791 (UMLS CUI-1)
Center number
Item
Center number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Volver a la parte superior de la página 

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