ID

33544

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

Keywords

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

GSK group of companies

Uploaded on

December 12, 2018

DOI

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License

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)

English

Visit 3: Study Continuation Check

1 forms  
Administrative data
Description

Administrative data

Protocol Number
Description

Protocol Number

Data type

integer

Subject Number
Description

Subject Number

Data type

integer

Date of Visit
Description

Date of Visit

Data type

date

Period
Description

Period

Data type

text

Check for Study Continuation
Description

Check for Study Continuation

Did the subject return for visit 3?
Description

Did the subject return for visit 3?

Data type

boolean

If No, please tick one most appropriate reason
Description

If No, please tick one most appropriate reason

Data type

text

If Serious adverse event, please specify the SAE number
Description

If Serious adverse event, please specify the SAE number

Data type

integer

If Other, please specify
Description

If Other, please specify

Data type

text

Please tick who took the decision
Description

Please tick who took the decision

Data type

text

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Visit 3: Study Continuation Check

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Protocol Number
Item
Protocol Number
integer
Subject Number
Item
Subject Number
integer
Date of Visit
Item
Date of Visit
date
Item
Period
text
Period
Code List
Period
CL Item
45 months post dose 1 in Malaria-026 (12 months after visit 2) (1)
Item Group
Check for Study Continuation
Did the subject return for visit 3?
Item
Did the subject return for visit 3?
boolean
Item
If No, please tick one most appropriate reason
text
If No, please tick one most appropriate reason
Code List
If No, please tick one most appropriate reason
CL Item
Serious adverse event (1)
CL Item
Other (2)
If Serious adverse event, please specify the SAE number
Item
If Serious adverse event, please specify the SAE number
integer
If Other, please specify
Item
If Other, please specify
text
Item
Please tick who took the decision
text
Please tick who took the decision
Code List
Please tick who took the decision
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
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