ID

36750

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 document is to be completed at Visit 1 / Informed Consent Visit in case of non-participation.

Link

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

Stichworte

Versionen (3)
  1. 11.12.18 11.12.18 -
  2. 11.12.18 11.12.18 -
  3. 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

Reason for Non Participation - Tracking Form

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Center Number
Beschreibung

Center number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Reason for non participation
Beschreibung

Reason for non participation

Alias
UMLS CUI-1
C0566251
UMLS CUI-2
C0558080
UMLS CUI-3
C2348568
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Subject could not be reached due to
Beschreibung

Reason subject not reached

Datentyp

text

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C1272705
Subject could be contacted
Beschreibung

Subject contacted

Datentyp

text

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C0681850
Record eligibility criteria that was failed
Beschreibung

if applies

Datentyp

text

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0231175
Subject is eligible but not willing to participate due to
Beschreibung

if applies

Datentyp

text

Alias
UMLS CUI [1,1]
C3846156
UMLS CUI [1,2]
C0392360
Day of contact
Beschreibung

In case of death, date of contact not requested

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
Investigator's Signature
Beschreibung

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's name (in Print)
Beschreibung

Investigator's name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Investigator's Signature
Beschreibung

Investigator's Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
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Ähnliche Modelle

Reason for Non Participation - Tracking Form

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Center number
Item
Center Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item Group
Reason for non participation
C0566251 (UMLS CUI-1)
C0558080 (UMLS CUI-2)
C2348568 (UMLS CUI-3)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item
Subject could not be reached due to
text
C0332158 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
Subject could not be reached due to
Code List
Subject could not be reached due to
CL Item
Lost to follow-up (LFU)
CL Item
Migrated/moved from study area (MIG)
CL Item
Death (DEA)
Item
Subject could be contacted
text
C0332158 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Subject could be contacted
Code List
Subject could be contacted
CL Item
Not eligible (record criteria) (NEL)
CL Item
Eligible but not willing to participate (record reason for it) (ELU)
Eligibility criteria that was failed
Item
Record eligibility criteria that was failed
text
C1516637 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Item
Subject is eligible but not willing to participate due to
text
C3846156 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Subject is eligible but not willing to participate due to
Code List
Subject is eligible but not willing to participate due to
CL Item
Consent withdrawal not due to an AE (CWS)
CL Item
Serious adverse event (SAE)
CL Item
Adverse event (AEX)
CL Item
Other (OTH)
Day of contact
Item
Day of contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator's name
Item
Investigator's name (in Print)
text
C2826892 (UMLS CUI [1])
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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