ID
42517
Descripción
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
Palabras clave
Versiones (1)
- 11/8/21 11/8/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
11 de agosto de 2021
DOI
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Licencia
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
Descripción
Local Symptoms (at Injection Site)
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C0042196
Descripción
Size: Please measure the greatest diameter (in mm).
Tipo de datos
integer
Unidades de medida
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Descripción
Please indicate the intensity of pain at injection site.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C2700396
Descripción
Local Symptoms (at Injection Site)
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
Descripción
Local Symptom
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Descripción
If yes, please indicate the date of the last day of symptoms in the following item.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2700396
- UMLS CUI [1,3]
- C0549178
Descripción
Date in time last symptoms
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Descripción
Other Local Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0205394
Descripción
Please give details below.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0678257
Descripción
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).
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0518690
Descripción
Please record the start date of the described local symptoms.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0808070
Descripción
Please record the end date of the described local symptoms OR tick box in the following item if continuing.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0806020
Descripción
Other local symptoms ongoing
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0549178
Descripción
Medication
Alias
- UMLS CUI-1
- C0013227
Descripción
Please fill in below if any medication has been taken since the vaccination
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [2,1]
- C0592502
- UMLS CUI [2,2]
- C0013227
Descripción
Indication of pharmaceutical preparations
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Descripción
Total Daily Dose
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2348070
- UMLS CUI [1,3]
- C0439810
Descripción
Please record the start date of the administration of the medication.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Descripción
Please record the end date of the administration of the medication OR tick box in the following item if continuing.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Descripción
Pharmaceutical preparations continuous
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Descripción
General Symptoms
Alias
- UMLS CUI-1
- C0159028
Descripción
General Symptoms
Alias
- UMLS CUI-1
- C0159028
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C0042196
Descripción
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.
Tipo de datos
float
Unidades de medida
- °C
Alias
- UMLS CUI [1]
- C0005903
Descripción
Please indicate the intensity for irritability / fussiness.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Descripción
Please indicate the intensity for drowsiness.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0013144
Descripción
Please indicate the intensity for loss of appetite.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1971624
Descripción
General Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C1517001
- UMLS CUI-3
- C0159028
Descripción
Please complete all items in this item group for every symptom.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0159028
Descripción
If yes, please indicate the date of the last day of symptoms in the following item.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0549178
Descripción
Date in time last general symptoms
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C0159028
Descripción
Other General Symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0205394
Descripción
Please give details below.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0678257
Descripción
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).
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0518690
Descripción
Please record the start date of the described general symptoms.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0808070
Descripción
Please record the end date of the described general symptoms OR tick box in the following item if continuing.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0806020
Descripción
Other general symptoms continuous
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0549178
Descripción
Administrative Documentation
Alias
- UMLS CUI-1
- C1320722
Descripción
Date in time subject diary visit return patient information
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C3890583
- UMLS CUI [1,3]
- C0545082
- UMLS CUI [1,4]
- C1548100
Descripción
Contact information hospitalisation person name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1880174
- UMLS CUI [1,2]
- C0019993
- UMLS CUI [1,3]
- C1547383
Descripción
Contact information hospitalisation telephone number
Tipo de datos
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])