ID

36768

Beschrijving

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 2.

Link

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

Trefwoorden

Versies (2)
  1. 11-12-18 11-12-18 -
  2. 06-06-19 06-06-19 -
Houder van rechten

GSK group of companies

Geüploaded op

6 juni 2019

DOI

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Licentie

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

Engels

Visit 2: Study Continuation Check

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschrijving

Date of Visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Check for Study Continuation
Beschrijving

Check for Study Continuation

Alias
UMLS CUI-1
C2348568
UMLS CUI-2
C0805733
Did the subject return for visit 2?
Beschrijving

If Yes, please complete the next pages. If No, Please tick the ONE most appropriate reason and skip the following pages of this visit, and please tick who took the decision.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
If No, please tick one most appropriate reason
Beschrijving

Reason for discontinuation

Datatype

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
If Serious adverse event, please specify the SAE number
Beschrijving

complete the Serious Adverse Event form

Datatype

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C1519255
If Other, please specify
Beschrijving

e.g.: consent withdrawal, Protocol violation, non-serious adverse event …

Datatype

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C1521902
Please tick who took the decision
Beschrijving

Discontinuation decision

Datatype

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
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Similar models

Visit 2: Study Continuation Check

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Check for Study Continuation
C2348568 (UMLS CUI-1)
C0805733 (UMLS CUI-2)
return for visit
Item
Did the subject return for visit 2?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
If No, please tick one most appropriate reason
text
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
If No, please tick one most appropriate reason
Code List
If No, please tick one most appropriate reason
CL Item
Serious adverse event (SAE)
CL Item
Other (OTH)
SAE number
Item
If Serious adverse event, please specify the SAE number
integer
C0600091 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other reason
Item
If Other, please specify
text
C3840932 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Item
Please tick who took the decision
text
C0679006 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Please tick who took the decision
Code List
Please tick who took the decision
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
Terug naar het begin van de pagina 

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