ID

36812

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 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 3.

Link

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

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

June 12, 2019

DOI

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License

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

English

Study Conclusion

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

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Occurrence of serious adverse event
Description

Occurrence of serious adverse event

Alias
UMLS CUI-1
C1519255
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

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C2242969
If Yes, specify total number of SAE's for the Malaria-039 period only
Description

number of SAEs in current trial

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347804
UMLS CUI [1,3]
C0449788
Subject Withdrawal
Description

Subject Withdrawal

Alias
UMLS CUI-1
C0422727
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

Alias
UMLS CUI [1]
C0422727
If Yes, choose one / major reason for withdrawal
Description

major reason for withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
If Death, please specify SAE number
Description

If Death, please specify SAE number

Data type

integer

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C2349022
Is Serious Adverse Event, please specify the SAE number
Description

Is Serious Adverse Event, please specify the SAE number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2349022
If Protocol violation, please specify
Description

If Protocol violation, please specify

Data type

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C2348235
If Other, please specify
Description

specify other reason for withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C0422727
Who made the decision?
Description

Withdrawal Decision

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
Date of last contact
Description

Date of last contact

Data type

date

Alias
UMLS CUI [1]
C0805839
Was the subject in good condition at date of last contact?
Description

If No, please give details in Adverse Event section

Data type

boolean

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C0805839
Investigator's Signature
Description

Investigator's Signature

Alias
UMLS CUI-1
C2346576
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

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0008961
Investigator's signature
Description

Investigator's signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator's name (in print)
Description

Investigator's name (in print)

Data type

text

Alias
UMLS CUI [1]
C2826892
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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
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Occurrence of serious adverse event
C1519255 (UMLS CUI-1)
Serious Adverse Event since last study
Item
Did the subject experience any Serious Adverse Event since Visit 7, Month 21 of Malaria-026 study?
boolean
C1519255 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C2242969 (UMLS CUI [1,3])
number of SAEs in current trial
Item
If Yes, specify total number of SAE's for the Malaria-039 period only
integer
C1519255 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Item Group
Subject Withdrawal
C0422727 (UMLS CUI-1)
subject withdrawn from the study?
Item
Is the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If Yes, choose one / major reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
If Yes, choose one reason for withdrawal
Code List
If Yes, choose one / major reason for withdrawal
CL Item
Death (DEA)
CL Item
Serious adverse event (SAE)
CL Item
Protocol violation (PTV)
CL Item
Consent withdrawal, not due to an adverse event (CWS)
CL Item
Migrated / moved from the study area (MIG)
CL Item
Lost to follow-up (LFU)
CL Item
Other (OTH)
If Death, please specify SAE number
Item
If Death, please specify SAE number
integer
C0011065 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C2349022 (UMLS CUI [1,3])
Is Serious Adverse Event, please specify the SAE number
Item
Is Serious Adverse Event, please specify the SAE number
integer
C1519255 (UMLS CUI [1,1])
C2349022 (UMLS CUI [1,2])
If Protocol violation, please specify
Item
If Protocol violation, please specify
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
specify other reason for withdrawal
Item
If Other, please specify
text
C2348235 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0422727 (UMLS CUI [1,4])
Item
Who made the decision?
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
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
C0805839 (UMLS CUI [1])
subject condition at last contact
Item
Was the subject in good condition at date of last contact?
boolean
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,3])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
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
C0750484 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator's name (in print)
Item
Investigator's name (in print)
text
C2826892 (UMLS CUI [1])
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