ID

33511

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 (3)
  1. 12/11/18 12/11/18 -
  2. 6/6/19 6/6/19 -
  3. 6/12/19 6/12/19 -
Copyright Holder

GSK group of companies

Uploaded on

December 11, 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

Study Conclusion

1 forms  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative data
Description

Administrative data

Protocol Number
Description

Protocol Number

Data type

integer

Subject Number
Description

Subject Number

Data type

integer

Occurrence of serious adverse event
Description

Occurrence of serious adverse event

Did the subject experience any Serious Adverse Event since Visit 7, Month 21 of Malaria-026 study?
Description

SAEs recorded up to Visit 7, Month 21 of Malaria-026 to be recorded in Malaria-026 SAE forms; SAEs recorded 1 day after Visit 7, Month 21 to be recorded in Malaria-039 SAE forms

Data type

boolean

If Yes, specify total number of SAE's for the Malaria-039 period only
Description

If Yes, specify total number of SAE's for the Malaria-039 period only

Data type

integer

Subject Withdrawal
Description

Subject Withdrawal

Is the subject withdrawn from the study?
Description

A subject is withdrawn from interim analysis if he/she did not come for the interim analysis timepoint visit

Data type

boolean

If Yes, choose one reason for withdrawal
Description

If Yes, choose one reason for withdrawal

Data type

text

If Death, please specify SAE number
Description

If Death, please specify SAE number

Data type

integer

Is Serious Adverse Event, please specify the SAE number
Description

Is Serious Adverse Event, please specify the SAE number

Data type

integer

If Protocol violation, please specify
Description

If Protocol violation, please specify

Data type

text

If Other, please specify
Description

If Other, please specify

Data type

text

Who made the decision?
Description

Who made the decision?

Data type

text

Date of last contact
Description

Date of last contact

Data type

date

Was the subject in good condition at date of last contact?
Description

Was the subject in good condition at date of last contact?

Data type

boolean

If No, please give details in Adverse Event section.
Description

If No, please give details in Adverse Event section.

Data type

text

Investigator's Signature
Description

Investigator's Signature

I confirm that I have reviewed the data in this Case Report for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Description

Investigator's confirmation

Data type

date

Investigator's signature
Description

Investigator's signature

Data type

text

Investigator's name (in print)
Description

Investigator's name (in print)

Data type

text

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Similar models

Study Conclusion

1 forms
  1. StudyEvent: ODM
    1. Study Conclusion
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
Item Group
Occurrence of serious adverse event
Did the subject experience any Serious Adverse Event since Visit 7, Month 21 of Malaria-026 study?
Item
Did the subject experience any Serious Adverse Event since Visit 7, Month 21 of Malaria-026 study?
boolean
If Yes, specify total number of SAE's for the Malaria-039 period only
Item
If Yes, specify total number of SAE's for the Malaria-039 period only
integer
Item Group
Subject Withdrawal
Is the subject withdrawn from the study?
Item
Is the subject withdrawn from the study?
boolean
Item
If Yes, choose one reason for withdrawal
text
If Yes, choose one reason for withdrawal
Code List
If Yes, choose one reason for withdrawal
CL Item
Death (1)
CL Item
Serious adverse event (2)
CL Item
Protocol violation, please specify (3)
CL Item
Consent withdrawal not due to an adverse event (4)
CL Item
Migrated/moved from the study area (5)
CL Item
Lost to follow-up (6)
CL Item
Other (7)
If Death, please specify SAE number
Item
If Death, please specify SAE number
integer
Is Serious Adverse Event, please specify the SAE number
Item
Is Serious Adverse Event, please specify the SAE number
integer
If Protocol violation, please specify
Item
If Protocol violation, please specify
text
If Other, please specify
Item
If Other, please specify
text
Item
Who made the decision?
text
Who made the decision?
Code List
Who made the decision?
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Date of last contact
Item
Date of last contact
date
Was the subject in good condition at date of last contact?
Item
Was the subject in good condition at date of last contact?
boolean
If No, please give details in Adverse Event section.
Item
If No, please give details in Adverse Event section.
text
Item Group
Investigator's Signature
Investigator's confirmation
Item
I confirm that I have reviewed the data in this Case Report for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
date
Investigator's signature
Item
Investigator's signature
text
Investigator's name (in print)
Item
Investigator's name (in print)
text
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