ID

36768

Beschreibung

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

Stichworte

Versionen (2)
  1. 11.12.18 11.12.18 -
  2. 06.06.19 06.06.19 -
Rechteinhaber

GSK group of companies

Hochgeladen am

6. Juni 2019

DOI

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Lizenz

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

Englisch

Visit 2: Study Continuation Check

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

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

Check for Study Continuation

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

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.

Datentyp

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
Beschreibung

Reason for discontinuation

Datentyp

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
Beschreibung

complete the Serious Adverse Event form

Datentyp

integer

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

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

Datentyp

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
Beschreibung

Discontinuation decision

Datentyp

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
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Ähnliche Modelle

Visit 2: Study Continuation Check

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
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