ID
42517
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). Parents/guardians are asked to fill in the Diary Card during the one-week period subsequent to each vaccination (i.e., post visit 2 [dose 1], visit 3 [dose 2], and visit 4 [dose 3]). Note that informed consent has to be obtained prior to any study procedure.
Link
https://clinicaltrials.gov/ct2/show/study/NCT00380393
Keywords
Versions (1)
- 8/11/21 8/11/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
August 11, 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
Diary Card for General and Local Symptoms
- StudyEvent: ODM
Description
Local Symptoms (at Injection Site)
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
Description
Please fill in the following two items for each day (day 0 to day 6) and assess the occurrence of any of the following signs or symptoms according to the respective criteria.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C0042196
Description
Size: Please measure the greatest diameter (in mm).
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Please indicate the intensity of pain at injection site.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C2700396
Description
Local Symptoms (at Injection Site)
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
Description
Local Symptom
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Description
If yes, please indicate the date of the last day of symptoms in the following item.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2700396
- UMLS CUI [1,3]
- C0549178
Description
Date in time last symptoms
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Description
Other Local Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0205394
Description
Please give details below.
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0678257
Description
Please indicate the intensity for other local symptoms by using the following scale: <br> 1 (Mild): An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. <br> 2 (Moderate): An adverse event which is sufficiently discomforting to interfere with normal everyday activities. <br> 3 (Severe): An adverse event which prevents normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice).
Data type
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0518690
Description
Please record the start date of the described local symptoms.
Data type
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0808070
Description
Please record the end date of the described local symptoms OR tick box in the following item if continuing.
Data type
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0806020
Description
Other local symptoms ongoing
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0549178
Description
Medication
Alias
- UMLS CUI-1
- C0013227
Description
Please fill in below if any medication has been taken since the vaccination
Data type
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [2,1]
- C0592502
- UMLS CUI [2,2]
- C0013227
Description
Indication of pharmaceutical preparations
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Description
Total Daily Dose
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2348070
- UMLS CUI [1,3]
- C0439810
Description
Please record the start date of the administration of the medication.
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
Please record the end date of the administration of the medication OR tick box in the following item if continuing.
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
Pharmaceutical preparations continuous
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Description
General Symptoms
Alias
- UMLS CUI-1
- C0159028
Description
General Symptoms
Alias
- UMLS CUI-1
- C0159028
Description
Please fill in the following items for each day (day 0 to day 6) and assess the occurrence of any of the following signs or symptoms according to the respective criteria.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C0042196
Description
Please record the temperature every day. Should additional temperature measurements be performed at other times of the day, the highest temperature is to be recorded.
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Please indicate the intensity for irritability / fussiness.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Description
Please indicate the intensity for drowsiness.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0013144
Description
Please indicate the intensity for loss of appetite.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1971624
Description
General Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C1517001
- UMLS CUI-3
- C0159028
Description
Please complete all items in this item group for every symptom.
Data type
text
Alias
- UMLS CUI [1]
- C0159028
Description
If yes, please indicate the date of the last day of symptoms in the following item.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0549178
Description
Date in time last general symptoms
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C0159028
Description
Other General Symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0205394
Description
Please give details below.
Data type
text
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0678257
Description
Please indicate the intensity for other general symptoms by using the following scale: <br> 1 (Mild): An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. <br> 2 (Moderate): An adverse event which is sufficiently discomforting to interfere with normal everyday activities. <br> 3 (Severe): An adverse event which prevents normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice).
Data type
integer
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0518690
Description
Please record the start date of the described general symptoms.
Data type
date
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0808070
Description
Please record the end date of the described general symptoms OR tick box in the following item if continuing.
Data type
date
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0806020
Description
Other general symptoms continuous
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0549178
Description
Administrative Documentation
Alias
- UMLS CUI-1
- C1320722
Description
Date in time subject diary visit return patient information
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C3890583
- UMLS CUI [1,3]
- C0545082
- UMLS CUI [1,4]
- C1548100
Description
Contact information hospitalisation person name
Data type
text
Alias
- UMLS CUI [1,1]
- C1880174
- UMLS CUI [1,2]
- C0019993
- UMLS CUI [1,3]
- C1547383
Description
Contact information hospitalisation telephone number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1880174
- UMLS CUI [1,2]
- C0019993
- UMLS CUI [1,3]
- C1515258
Similar models
Diary Card for General and Local Symptoms
- StudyEvent: ODM
C0042210 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
C0205276 (UMLS CUI-2)
C0687676 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0205276 (UMLS CUI-2)
C2700396 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0678257 (UMLS CUI [1,4])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,4])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
C0013227 (UMLS CUI [1,2])
C0592502 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0013227 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0449687 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0022107 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,2])
C1517001 (UMLS CUI-2)
C0159028 (UMLS CUI-3)
C0549178 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C3890583 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C1548100 (UMLS CUI [1,4])
C0019993 (UMLS CUI [1,2])
C1547383 (UMLS CUI [1,3])
C0019993 (UMLS CUI [1,2])
C1515258 (UMLS CUI [1,3])