ID
42544
Beschreibung
Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria ODM derived from https://clinicaltrials.gov/ct2/show/NCT00307021. A Phase II randomized, double-blind bridging study of the safety and immunogenicity of GlaxoSmithKline Plasmodium falciparum malaria vaccine RTS,S/AS01E (0.5 mL dose) to RTS,S/AS02D (0.5 mL dose) administered IM according to a 0, 1, 2- month vaccination schedule in children aged 18 months to 4 years living in Gabon. Clinical Visits: This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). Vaccine administration takes place during visits 2, 4, and 5 (Visit 2 = Dose 1; Visit 4 = Dose 2; Visit 5 = Dose 3). Field-worker Visits: During the double-blind phase, clinical visits are accompanied by daily field-worker visits subsequent to each vaccine administration visit. Additional field-worker visits also take place during months 4 to 13 of the single-blind phase. 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 4 [dose 2], and visit 5 [dose 3]). Note that informed consent has to be obtained prior to any study procedure.
Link
https://clinicaltrials.gov/ct2/show/NCT00307021
Stichworte
Versionen (1)
- 24.08.21 24.08.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
24. August 2021
DOI
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Lizenz
Creative Commons BY-NC 4.0
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Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021
Diary Card for General and Local Symptoms
- StudyEvent: ODM
Beschreibung
Local Symptoms (at Injection Sites)
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C0042196
Beschreibung
Size: Please measure the greatest diameter (in mm).
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beschreibung
Please indicate the intensity of pain at injection site.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C2700396
Beschreibung
Local Symptoms (at Injection Site)
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
Beschreibung
Local Symptom
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Beschreibung
If yes, please indicate the date of the last day of symptoms in the following item.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2700396
- UMLS CUI [1,3]
- C0549178
Beschreibung
Date in time last symptoms
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Beschreibung
Other Local Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0205394
Beschreibung
Please give details below.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0678257
Beschreibung
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).
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0518690
Beschreibung
Please record the start date of the described local symptoms.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0808070
Beschreibung
Please record the end date of the described local symptoms OR tick box in the following item if continuing.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0806020
Beschreibung
Other local symptoms continuous
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0549178
Beschreibung
Medication
Alias
- UMLS CUI-1
- C0013227
Beschreibung
Please fill in this item group if any medication has been taken since the vaccination
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [2,1]
- C0592502
- UMLS CUI [2,2]
- C0013227
Beschreibung
Indication of pharmaceutical preparations
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschreibung
Total Daily Dose
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2348070
- UMLS CUI [1,3]
- C0439810
Beschreibung
Please record the start date of the administration of the medication.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschreibung
Please record the end date of the administration of the medication OR tick box in the following item if continuing.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschreibung
Pharmaceutical preparations continuous
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Beschreibung
General Symptoms
Alias
- UMLS CUI-1
- C0159028
Beschreibung
General Symptoms
Alias
- UMLS CUI-1
- C0159028
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C0042196
Beschreibung
Please record the temperature every day in the evening. Should additional temperature measurements be performed at other times of the day, the highest temperature is to be recorded.
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Please indicate the intensity for irritability / fussiness.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Beschreibung
Please indicate the intensity for drowsiness.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0013144
Beschreibung
Please indicate the intensity for loss of appetite.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1971624
Beschreibung
General Symptoms
Alias
- UMLS CUI-1
- C0159028
Beschreibung
Please complete all items in this item group for every symptom.
Datentyp
text
Alias
- UMLS CUI [1]
- C0159028
Beschreibung
If yes, please indicate the date of the last day of symptoms in the following item.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0549178
Beschreibung
Date in time last general symptoms
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C0159028
Beschreibung
Other General Symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0205394
Beschreibung
Please give details below.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0678257
Beschreibung
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).
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0518690
Beschreibung
Please record the start date of the described general symptoms.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0808070
Beschreibung
Please record the end date of the described general symptoms OR tick box in the following item if continuing.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0806020
Beschreibung
Other general symptoms continuous
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0549178
Beschreibung
Administrative Documentation
Alias
- UMLS CUI-1
- C1320722
Beschreibung
Date in time subject diary visit return patient information
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C3890583
- UMLS CUI [1,3]
- C0545082
- UMLS CUI [1,4]
- C1548100
Beschreibung
Contact information hospitalisation person name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1880174
- UMLS CUI [1,2]
- C0019993
- UMLS CUI [1,3]
- C1547383
Beschreibung
Contact information hospitalisation telephone number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1880174
- UMLS CUI [1,2]
- C0019993
- UMLS CUI [1,3]
- C1515258
Ähnliche Modelle
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])
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])