ID

36820

Description

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 form is to be completed at/before Visit 2.

Link

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

Keywords

Versions (3)
  1. 12/12/18 12/12/18 -
  2. 6/6/19 6/6/19 -
  3. 6/12/19 6/12/19 -
Copyright Holder

GSK group of companies

Uploaded on

June 12, 2019

DOI

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License

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

English

Absence from Study Area - Interim Analysis

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Record Absences of ≥ 2 weeks - Interim Analysis
Description

Record Absences of ≥ 2 weeks - Interim Analysis

Alias
UMLS CUI-1
C0332197
UMLS CUI-2
C0681784
UMLS CUI-3
C0008976
UMLS CUI-5
C0449238
Has the subject been absent for more than 2 weeks?
Description

absences

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0681784
UMLS CUI [1,3]
C0008976
Dates of Absence from Study area
Description

Dates of Absence from Study area

Alias
UMLS CUI-1
C0011008
UMLS CUI-2
C0332197
UMLS CUI-3
C0681784
UMLS CUI-4
C0008976
Approximate date subject left study area
Description

Beginning of absence from study area

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0681784
UMLS CUI [1,4]
C0008976
Approximate date subject returned to study area
Description

End of absence from study area

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0681784
UMLS CUI [1,4]
C0008976
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Similar models

Absence from Study Area - Interim Analysis

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item Group
Record Absences of ≥ 2 weeks - Interim Analysis
C0332197 (UMLS CUI-1)
C0681784 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
C0449238 (UMLS CUI-5)
absences
Item
Has the subject been absent for more than 2 weeks?
boolean
C0332197 (UMLS CUI [1,1])
C0681784 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item Group
Dates of Absence from Study area
C0011008 (UMLS CUI-1)
C0332197 (UMLS CUI-2)
C0681784 (UMLS CUI-3)
C0008976 (UMLS CUI-4)
Beginning of absence from study area
Item
Approximate date subject left study area
date
C0808070 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0681784 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
End of absence from study area
Item
Approximate date subject returned to study area
date
C0806020 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0681784 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
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