ID

36811

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 document is to be completed at/after Visit 2.

Link

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

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

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 - Interim Analysis

1 forms  
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 events
Description

Occurrence of serious adverse events

Alias
UMLS CUI-1
C1519255
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

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C2242969
Specify total number of SAEs 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Is the subject withdrawn from the study?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 the interim analysis if he/she did not come for the interim analysis timepoint visit

Data type

boolean

Alias
UMLS CUI [1]
C0422727
Major reason for withdrawal
Description

tick one box only

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
In case of death, please specify SAE number
Description

In case of death, please specify SAE number

Data type

integer

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C2349022
In case of serious adverse event, specify SAE number
Description

Please also complete and submit SAE report

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2349022
In case of protocol violation, specify
Description

In case of protocol violation, specify

Data type

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C2348235
In other cases, 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 Events section

Data type

text

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 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

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 - Interim Analysis

1 forms
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 events
C1519255 (UMLS CUI-1)
Serious Adverse Events
Item
Did the subject experience any Serious Adverse Event since Visit 7, Month 21 of Malaria-026?
boolean
C1519255 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C2242969 (UMLS CUI [1,3])
Number of SAEs in current trial
Item
Specify total number of SAEs 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?
Item
Is the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Major reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Major reason for withdrawal
Code List
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)
In case of death, please specify SAE number
Item
In case of death, please specify SAE number
integer
C0011065 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C2349022 (UMLS CUI [1,3])
In case of serious adverse event, specify SAE number
Item
In case of serious adverse event, specify SAE number
integer
C1519255 (UMLS CUI [1,1])
C2349022 (UMLS CUI [1,2])
In case of protocol violation, specify
Item
In case of protocol violation, specify
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
specify other reason for withdrawal
Item
In other cases, 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])
Item
Was the subject in good condition at date of last contact?
text
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,3])
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  (2)
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 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
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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