ID

33506

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 CRF Seiten: 378-420

Stichworte

Versionen (3)
  1. 11.12.18 11.12.18 -
  2. 11.12.18 11.12.18 -
  3. 06.06.19 06.06.19 -
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GSK group of companies

Hochgeladen am

11. Dezember 2018

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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)

Englisch

Reason for Non Participation - Tracking Form

1 Formulare  
Administrative data
Beschreibung

Administrative data

Protocol Number
Beschreibung

Protocol Number

Datentyp

text

Previous study
Beschreibung

Previous study

Datentyp

text

Center Number
Beschreibung

Center number

Datentyp

integer

Reason for non participation
Beschreibung

Reason for non participation

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Subject could not be reached due to
Beschreibung

Subject could not be reached due to

Datentyp

text

Subject could be contacted
Beschreibung

Subject could be contacted

Datentyp

text

Record eligibility criteria that was failed
Beschreibung

if applies

Datentyp

text

Subject is eligible but not willing to participate due to
Beschreibung

if applies

Datentyp

text

Day of contact
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Day of contact

Datentyp

date

In case of death, date of contact not requested
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In case of death, date of contact not requested

Investigator's Signature
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Investigator's Signature

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Investigator's name (in Print)

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text

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Investigator's Signature

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text

Date
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Date

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date

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Reason for Non Participation - Tracking Form

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
Protocol Number
Item
Protocol Number
text
Item
Previous study
text
Previous study
Code List
Previous study
CL Item
257049/026 (Malaria-026) (1)
Center number
Item
Center Number
integer
Item Group
Reason for non participation
Subject Number
Item
Subject Number
integer
Item
Subject could not be reached due to
text
Subject could not be reached due to
Code List
Subject could not be reached due to
CL Item
Lost to follow-up (1)
CL Item
Migrated/moved from study area (2)
CL Item
Death (3)
Item
Subject could be contacted
text
Subject could be contacted
Code List
Subject could be contacted
CL Item
Not eligible (record criteria) (1)
CL Item
Eligible but not willing to participate (record reason for it) (2)
Record eligibility criteria that was failed
Item
Record eligibility criteria that was failed
text
Item
Subject is eligible but not willing to participate due to
text
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 (1)
CL Item
Serious adverse event (2)
CL Item
Adverse event (3)
CL Item
Other (4)
Day of contact
Item
Day of contact
date
Item Group
In case of death, date of contact not requested
Item Group
Investigator's Signature
Investigator's name (in Print)
Item
Investigator's name (in Print)
text
Investigator's Signature
Item
Investigator's Signature
text
Date
Item
Date
date
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