ID

42497

Description

Study ID: 106464 Clinical Study ID: 106464 Study Title: A Study of the Efficacy Against Episodes of Clinical Malaria Due to P. Falciparum Infection of GSK Biologicals Candidate Vaccine RTS, S/AS01, Administered According to a 0,1,2-months Schedule in Children Aged 5 to 17 Months Living in Tanzania & Kenya Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00380393 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK malaria vaccine 257049 Vaccine, Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine Trade Name: N/A Study Indication: Malaria ODM derived from https://clinicaltrials.gov/ct2/show/study/NCT00380393. This Phase IIb randomized, double-blind, controlled study of the efficacy against episodes of clinical malaria due to Plasmodium falciparum infection of GlaxoSmithKline Biologicals’ candidate vaccine RTS, S/AS01E, administered IM according to a 0, 1, 2-month vaccination schedule in children aged 5 months to 17 months living in Tanzania and Kenya. This study includes the following 7 clinical study visits (3 different visit types) during a double-blind phase (Day -60 to Month 6 1/2) and a single-blind phase including an extension for a subset of patients (month 7 to month 14). Clinical visit 1: Baseline visit, screening, and randomisation (DAY -60 to 0) Clinical visit 2: Vaccination I (MONTH 0, DAY 0 | DOSE 1 | 0 - 60 DAYS AFTER VISIT 1) Clinical visit 3: Vaccination II (MONTH 1, DAY 30 | DOSE 2 | 21 - 35 DAYS AFTER VISIT 2) Clinical visit 4: Vaccination III (MONTH 2, DAY 60 | DOSE 3 | 21 - 35 DAYS AFTER VISIT 3) Clinical visit 5: Blood Sample, ACD (MONTH 3, DAY 90 | 21 - 42 DAYS AFTER VISIT 4) Clinical visit 6: Blood Sample, ACD (MONTH 6 1/2 | CROSS-SECTIONAL VISIT FOR ACD | FINAL STUDY VISIT FOR DOUBLE-BLIND PHASE) Clinical visit 7: Blood Sample, ACD (MONTH 14 | FINAL STUDY VISIT SINGLE-BLIND PHASE) Field-worker home visits: During the vaccination period, clinical visits are accompanied by daily field-worker visits for a one-week period subsequent to each vaccine administration at clinical visits 2, 3, and 4 (visit code 21-26 following clinical visit 2; visit code 27-32 following clinical visit 3; visit code 33-38 following clinical visit 4). After completion of the vaccination period, clinical visits are then accompanied by weekly field-worker home visits (visit code 39-40 following clinical visit 4/dose 3; visit code 41-55 following clinical visit 5; visit code 56-86 following clinical visit 6). These visits serve the additional purpose of Active Case Detection (ACD). Passive Case Detection (PCD) for clinical malaria disease is performed both during the course of the double-blind (day -60 to month 6 1/2) and the single-blind phase (month 7 to month 14). For all subjects enrolled, please complete the study conclusion form. Study conclusion should be documented subsequently to clinical visit 7 in separate forms for the double-blind and the single-blind phase respectively. The 'Status of Treatment Blind' item group only needs to be completed within the form for the double-blind phase. Note that informed consent has to be obtained prior to any study procedure.

Link

https://clinicaltrials.gov/ct2/show/study/NCT00380393

Keywords

Versions (1)
  1. 8/1/21 8/1/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 1, 2021

DOI

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License

Creative Commons BY-NC 4.0
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Efficacy of P. Falciparum Vaccine Against Malaria in Children NCT00380393

English

Study Conclusion

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

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Please specify the study phase for which the form is filled in.
Description

Study phase

Data type

text

Alias
UMLS CUI [1,1]
C0205390
UMLS CUI [1,2]
C2603343
Occurrence of Serious Adverse Events
Description

Occurrence of Serious Adverse Events

Alias
UMLS CUI-1
C1519255
Did the subject experience any Serious Adverse Event during the study period?
Description

Serious adverse event during clinical trial period

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
If yes, specify total number of SAEs.
Description

Serious adverse event during clinical trial period count specification

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
UMLS CUI [1,4]
C0750480
UMLS CUI [1,5]
C1521902
Status of Treatment Blind, only to be completed for the double-blind phase questionnaire
Description

Status of Treatment Blind, only to be completed for the double-blind phase questionnaire

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study period?
Description

Only to be completed for the double-blind phase questionnaire.

Data type

boolean

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
If yes, complete date.
Description

Subject unblinding event record date

Data type

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
If yes, tick one reason below.
Description

Complete Non-Serious Adverse Event section or a Serious Adverse Event report as appropriate.

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205225
If other, please specify.
Description

Subject unblinding event record other reason to specify

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C1521902
Elimination Criteria
Description

Elimination Criteria

Alias
UMLS CUI-1
C0680251
Did any elimination criteria become applicable during the study period?
Description

Elimination criteria during clinical trial period

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
If yes, please specify.
Description

Elimination criteria to specify

Data type

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1521902
Was the subject withdrawn from the study?
Description

Patient withdrawn from trial

Data type

boolean

Alias
UMLS CUI [1]
C0422727
If yes, indicate the major reason for withdrawal.
Description

Please tick one box only. If serious adverse event [SAE], please complete and submit SAE report. If non-serious adverse event [AEX], please complete non-serious adverse event section. Note that non-serious adverse event [AEX] is only selectable as an option when completing the questionnaire for the double-blind phase.

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205225
If death [DEA], please specify SAE number.
Description

Death-related serious adverse event number to specify

Data type

integer

Alias
UMLS CUI [1,1]
C1705232
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0237753
UMLS CUI [1,4]
C1521902
If serious adverse event [SAE], please specify SAE number.
Description

Serious adverse event number to specify

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1521902
If non-serious adverse event [AEX], please specify AE number.
Description

Or specify solicited AE code in the following item. Note that non-serious adverse events are only specifiable when completing the questionnaire for the double-blind phase.

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1521902
If non-serious adverse event [AEX], please specify solicited adverse event code.
Description

Or specify non-serious adverse event number in the previous item. Note that non-serious adverse events are only specifiable when completing the questionnaire for the double-blind phase.

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1517001
UMLS CUI [1,3]
C0805701
UMLS CUI [1,4]
C1521902
If protocol violation [PTV], please specify.
Description

Protocol violation to specify

Data type

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C1521902
If other [OTH], please specify.
Description

Withdrawal other reason to specify

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C1521902
If yes, indicate who made the decision.
Description

Withdrawal decision maker

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
If subject was withdrawn from the study, indicate the date of the last contact.
Description

Withdrawal date of last contact

Data type

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0805839
If withdrawn from the study, was the subject in good condition at date of last contact?
Description

If no, please give details in Adverse Events section.

Data type

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1142435
UMLS CUI [1,3]
C0805839
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.

Alias
UMLS CUI-1
C2346576
Investigator's signature
Description

Investigator signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Printed investigator's name
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Date
Description

Investigator signature date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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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 Documentation
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Please specify the study phase for which the form is filled in.
text
C0205390 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
Study phase
Code List
Please specify the study phase for which the form is filled in.
CL Item
double-blind phase ([D])
CL Item
single-blind phase ([S])
Item Group
Occurrence of Serious Adverse Events
C1519255 (UMLS CUI-1)
Serious adverse event during clinical trial period
Item
Did the subject experience any Serious Adverse Event during the study period?
boolean
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Serious adverse event during clinical trial period count specification
Item
If yes, specify total number of SAEs.
integer
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
Item Group
Status of Treatment Blind, only to be completed for the double-blind phase questionnaire
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Subject unblinding event record during clinical trial period
Item
Was the treatment blind broken during the study period?
boolean
C3897431 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Subject unblinding event record date
Item
If yes, complete date.
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If yes, tick one reason below.
text
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Subject unblinding event record reason and justification
Code List
If yes, tick one reason below.
CL Item
Medical emergency requiring identification of investigational product for further treatments ([1])
CL Item
Other ([9])
Subject unblinding event record other reason to specify
Item
If other, please specify.
text
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Item Group
Elimination Criteria
C0680251 (UMLS CUI-1)
Elimination criteria during clinical trial period
Item
Did any elimination criteria become applicable during the study period?
boolean
C0680251 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Elimination criteria to specify
Item
If yes, please specify.
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Patient withdrawn from trial
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If yes, indicate the major reason for withdrawal.
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Withdrawal reason and justification primary
Code List
If yes, indicate the major reason for withdrawal.
CL Item
Death ([DEA])
CL Item
Serious adverse event ([SAE])
CL Item
Non-serious adverse event ([AEX])
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])
Death-related serious adverse event number to specify
Item
If death [DEA], please specify SAE number.
integer
C1705232 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Serious adverse event number to specify
Item
If serious adverse event [SAE], please specify SAE number.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Non-serious adverse event number specification
Item
If non-serious adverse event [AEX], please specify AE number.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
If non-serious adverse event [AEX], please specify solicited adverse event code.
text
C0877248 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Solicited adverse event code specification
Code List
If non-serious adverse event [AEX], please specify solicited adverse event code.
CL Item
Fever ([FE])
CL Item
Irritability/Fussiness ([IR])
CL Item
Drowsiness ([DR])
CL Item
Loss of appetite ([LO])
Protocol violation to specify
Item
If protocol violation [PTV], please specify.
text
C1709750 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Withdrawal other reason to specify
Item
If other [OTH], please specify.
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Item
If yes, indicate who made the decision.
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Trial Screen Failure | withdrawal before randomization | withdrawal before vaccination
Code List
If yes, indicate who made the decision.
CL Item
Investigator ([I])
CL Item
Parents/Guardians ([P])
Withdrawal date of last contact
Item
If subject was withdrawn from the study, indicate the date of the last contact.
date
C0422727 (UMLS CUI [1,1])
C0805839 (UMLS CUI [1,2])
Withdrawal general physical condition date last contact
Item
If withdrawn from the study, was the subject in good condition at date of last contact?
boolean
C0422727 (UMLS CUI [1,1])
C1142435 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,3])
Item Group
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.
C2346576 (UMLS CUI-1)
Investigator signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator name
Item
Printed investigator's name
text
C2826892 (UMLS CUI [1])
Investigator signature date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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