ID

36758

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 Visit 1.

Link

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

Keywords

Versions (3)
  1. 12/11/18 12/11/18 -
  2. 6/5/19 6/5/19 -
  3. 6/6/19 6/6/19 - Sarah Riepenhausen
Copyright Holder

GSK group of companies

Uploaded on

June 6, 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

Visit 1: Eligibility Criteria

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
Eligibility Check
Description

Eligibility Check

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Description

If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1550543
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Completion of Visit 7, Month 21 of Malaria-026
Description

Completion of last visit of previous study

Data type

boolean

Alias
UMLS CUI [1,1]
C0805732
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C2242969
Written informed consent obtained from the parent(s) or guardian(s) of the subject
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Planned use of any investigational or non-registered drug or vaccine during the study period
Description

Planned use of investigational or non-registered drug/vaccine during study period

Data type

boolean

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C2347804
UMLS CUI [2,1]
C1301732
UMLS CUI [2,2]
C1517586
UMLS CUI [2,3]
C0042210
UMLS CUI [2,4]
C0347984
UMLS CUI [2,5]
C2347804
Simultaneous participation in any other clinical trial
Description

Simultaneous other clinical trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348568
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Similar models

Visit 1: Eligibility Criteria

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])
Item Group
Eligibility Check
C0013893 (UMLS CUI-1)
Entry criteria met
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Completion of last visit of previous study
Item
Completion of Visit 7, Month 21 of Malaria-026
boolean
C0805732 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C2242969 (UMLS CUI [1,4])
Informed Consent
Item
Written informed consent obtained from the parent(s) or guardian(s) of the subject
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Planned use of investigational or non-registered drug/vaccine during study period
Item
Planned use of any investigational or non-registered drug or vaccine during the study period
boolean
C1301732 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C1301732 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
C0347984 (UMLS CUI [2,4])
C2347804 (UMLS CUI [2,5])
Simultaneous other clinical trial
Item
Simultaneous participation in any other clinical trial
boolean
C0205394 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
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