ID
42517
Beskrivning
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.
Länk
https://clinicaltrials.gov/ct2/show/study/NCT00380393
Nyckelord
Versioner (1)
- 2021-08-11 2021-08-11 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
11 augusti 2021
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 4.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Efficacy of P. Falciparum Vaccine Against Malaria in Children NCT00380393
Diary Card for General and Local Symptoms
- StudyEvent: ODM
Beskrivning
Local Symptoms (at Injection Site)
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C0042196
Beskrivning
Size: Please measure the greatest diameter (in mm).
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beskrivning
Please indicate the intensity of pain at injection site.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C2700396
Beskrivning
Local Symptoms (at Injection Site)
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
Beskrivning
Local Symptom
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Beskrivning
If yes, please indicate the date of the last day of symptoms in the following item.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2700396
- UMLS CUI [1,3]
- C0549178
Beskrivning
Date in time last symptoms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Beskrivning
Other Local Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0205394
Beskrivning
Please give details below.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0678257
Beskrivning
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).
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0518690
Beskrivning
Please record the start date of the described local symptoms.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0808070
Beskrivning
Please record the end date of the described local symptoms OR tick box in the following item if continuing.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0806020
Beskrivning
Other local symptoms ongoing
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0549178
Beskrivning
Medication
Alias
- UMLS CUI-1
- C0013227
Beskrivning
Please fill in below if any medication has been taken since the vaccination
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [2,1]
- C0592502
- UMLS CUI [2,2]
- C0013227
Beskrivning
Indication of pharmaceutical preparations
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beskrivning
Total Daily Dose
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2348070
- UMLS CUI [1,3]
- C0439810
Beskrivning
Please record the start date of the administration of the medication.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beskrivning
Please record the end date of the administration of the medication OR tick box in the following item if continuing.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beskrivning
Pharmaceutical preparations continuous
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Beskrivning
General Symptoms
Alias
- UMLS CUI-1
- C0159028
Beskrivning
General Symptoms
Alias
- UMLS CUI-1
- C0159028
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C0042196
Beskrivning
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.
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Please indicate the intensity for irritability / fussiness.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Beskrivning
Please indicate the intensity for drowsiness.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0013144
Beskrivning
Please indicate the intensity for loss of appetite.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1971624
Beskrivning
General Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C1517001
- UMLS CUI-3
- C0159028
Beskrivning
Please complete all items in this item group for every symptom.
Datatyp
text
Alias
- UMLS CUI [1]
- C0159028
Beskrivning
If yes, please indicate the date of the last day of symptoms in the following item.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0549178
Beskrivning
Date in time last general symptoms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C0159028
Beskrivning
Other General Symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0205394
Beskrivning
Please give details below.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0678257
Beskrivning
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).
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0518690
Beskrivning
Please record the start date of the described general symptoms.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0808070
Beskrivning
Please record the end date of the described general symptoms OR tick box in the following item if continuing.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0806020
Beskrivning
Other general symptoms continuous
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0549178
Beskrivning
Administrative Documentation
Alias
- UMLS CUI-1
- C1320722
Beskrivning
Date in time subject diary visit return patient information
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C3890583
- UMLS CUI [1,3]
- C0545082
- UMLS CUI [1,4]
- C1548100
Beskrivning
Contact information hospitalisation person name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1880174
- UMLS CUI [1,2]
- C0019993
- UMLS CUI [1,3]
- C1547383
Beskrivning
Contact information hospitalisation telephone number
Datatyp
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])