ID

33543

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. 12/12/18 12/12/18 -
  2. 6/6/19 6/6/19 -
  3. 6/12/19 6/12/19 -
Copyright Holder

GSK group of companies

Uploaded on

December 12, 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 - Interim Analysis

1 forms  
Administrative data
Description

Administrative data

Protocol Number
Description

Protocol Number

Data type

integer

Subject Number
Description

Subject Number

Data type

integer

Period
Description

Period

Data type

text

Study Conclusion
Description

Study Conclusion

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

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

Data type

boolean

Specify total number of SAEs for the Malaria 039 period only
Description

Total number of SAEs 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Is the subject withdrawn from the study?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A subject is withdrawn from the interim analysis if he/she did not come for the interim analysis timepoint visit

Data type

boolean

Major reason for withdrawal
Description

tick one box only

Data type

text

In case of death, please specify SAE number
Description

In case of death, please specify SAE number

Data type

integer

In case of serious adverse event, specify SAE number
Description

In case of serious adverse event, specify SAE number

Data type

integer

In case of protocol violation, specify
Description

In case of protocol violation, specify

Data type

text

In other cases, specify
Description

In other cases, 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

text

Investigator's Signature
Description

Investigator's Signature

I confirm that I have reviewed the data in this Case Report Form 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

I confirm that I have reviewed the data in this Case Report Form 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.

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 - Interim Analysis

1 forms
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
Period
text
Period
Code List
Period
CL Item
12 months after visit 1 (1)
Item Group
Study Conclusion
Did the subject experience any Serious Adverse Event since Visit 7, Month 21 of Malaria-026?
Item
Did the subject experience any Serious Adverse Event since Visit 7, Month 21 of Malaria-026?
boolean
Total number of SAEs for the Malaria 039 period only
Item
Specify total number of SAEs 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
Major reason for withdrawal
text
Major reason for withdrawal
Code List
Major reason for withdrawal
CL Item
Death (1)
CL Item
Serious adverse event (2)
CL Item
Protocol violation (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)
In case of death, please specify SAE number
Item
In case of death, please specify SAE number
integer
In case of serious adverse event, specify SAE number
Item
In case of serious adverse event, specify SAE number
integer
In case of protocol violation, specify
Item
In case of protocol violation, specify
text
In other cases, specify
Item
In other cases, specify
text
Item
Who made the decision
text
Who made the decision
Code List
Who made the decision
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
Date of last contact
Item
Date of last contact
date
Item
Was the subject in good condition at date of last contact?
text
Was the subject in good condition at date of last contact?
Code List
Was the subject in good condition at date of last contact?
CL Item
Yes (1)
CL Item
No -> If No, please give details in Adverse Events section (2)
Item Group
Investigator's Signature
I confirm that I have reviewed the data in this Case Report Form 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.
Item
I confirm that I have reviewed the data in this Case Report Form 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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