ID

42544

Description

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

Keywords

Versions (1)
  1. 8/24/21 8/24/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 24, 2021

DOI

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License

Creative Commons BY-NC 4.0
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Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021

English

Diary Card for General and Local Symptoms

1 forms  
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Vaccine dose number
Description

Vaccine dose number

Data type

integer

Alias
UMLS CUI [1,1]
C1115464
UMLS CUI [1,2]
C0042210
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Day 0 = date of vaccination
Description

Date in time vaccination

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
Local Symptoms (at Injection Sites)
Description

Local Symptoms (at Injection Sites)

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
Day
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
Swelling, size (mm)
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
mm
Pain intensity
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
Local Symptoms (at Injection Site)
Description

Local Symptoms (at Injection Site)

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
Local Symptom
Description

Local Symptom

Data type

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Ongoing after Day 6?
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
Date of the last day of symptoms
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
Other Local Symptoms
Description

Other Local Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0205394
Description
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
Intensity
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
Start date
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
End date
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
Other local symptoms continuing
Description

Other local symptoms continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0549178
Medication
Description

Medication

Alias
UMLS CUI-1
C0013227
Medication trade/generic name
Description

Please fill in this item group 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
Reason
Description

Indication of pharmaceutical preparations

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Total Daily Dose
Description

Total Daily Dose

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0439810
Start Date
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
End Date
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
Medication continuing
Description

Pharmaceutical preparations continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
General Symptoms
Description

General Symptoms

Alias
UMLS CUI-1
C0159028
Body temperature measurement site
Description

Please consider axillary measurement [A] to be the mandatory route.

Data type

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0449687
General Symptoms
Description

General Symptoms

Alias
UMLS CUI-1
C0159028
Day
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
Body temperature
Description

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.

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Irritability/Fussiness intensity
Description

Please indicate the intensity for irritability / fussiness.

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0022107
Drowsiness intensity
Description

Please indicate the intensity for drowsiness.

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0013144
Loss of appetite intensity
Description

Please indicate the intensity for loss of appetite.

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1971624
General Symptoms
Description

General Symptoms

Alias
UMLS CUI-1
C0159028
Symptom
Description

Please complete all items in this item group for every symptom.

Data type

text

Alias
UMLS CUI [1]
C0159028
Ongoing after Day 6?
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
Date of the last day of symptoms
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
Other General Symptoms
Description

Other General Symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0205394
Description
Description

Please give details below.

Data type

text

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0678257
Intensity
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
Start date
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
End date
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
Other general symptoms continuing
Description

Other general symptoms continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0549178
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Please do not forgive to bring back the diary card on:
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
In case of hospitalisation, please inform:
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
In case of hospitalisation, please inform:
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
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Similar models

Diary Card for General and Local Symptoms

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Item
Vaccine dose number
integer
C1115464 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Visit number
Code List
Vaccine dose number
CL Item
dose 1 (1)
CL Item
dose 2 (2)
CL Item
dose 3 (3)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date in time vaccination
Item
Day 0 = date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item Group
Local Symptoms (at Injection Sites)
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
Day post vaccination
Item
Day
integer
C0439228 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Swelling size injection site
Item
Swelling, size (mm)
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Pain intensity
integer
C0518690 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Symptom intensity pain injection site
Code List
Pain intensity
CL Item
Absent (0)
CL Item
Minor reaction to touch (1)
CL Item
Cries/protests on touch (2)
CL Item
Cries when limb is moved/spontaneously painful (3)
Item Group
Local Symptoms (at Injection Site)
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
Item
Local Symptom
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local Symptom
Code List
Local Symptom
CL Item
Swelling ([SW])
CL Item
Pain ([PA])
Symptoms injection site continuous
Item
Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Date in time last symptoms
Item
Date of the last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
Other Local Symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Other local symptoms description
Item
Description
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0678257 (UMLS CUI [1,4])
Item
Intensity
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,4])
Vaccination local symptom intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Other local symptoms start date
Item
Start date
date
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
Other local symptoms end date
Item
End date
date
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Other local symptoms continuous
Item
Other local symptoms continuing
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Item Group
Medication
C0013227 (UMLS CUI-1)
Trade name | generic name of pharmaceutical preparation
Item
Medication trade/generic name
text
C2360065 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0592502 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Indication of pharmaceutical preparations
Item
Reason
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Pharmaceutical preparations start date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Pharmaceutical preparations end date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Pharmaceutical preparations continuous
Item
Medication continuing
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
General Symptoms
C0159028 (UMLS CUI-1)
Item
Body temperature measurement site
text
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
Body temperature measurement site
Code List
Body temperature measurement site
CL Item
Axillary (mandatory) ([A])
CL Item
Oral ([O])
CL Item
Rectal ([R])
Item Group
General Symptoms
C0159028 (UMLS CUI-1)
Day post vaccination
Item
Day
integer
C0439228 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Body temperature
Item
Body temperature
float
C0005903 (UMLS CUI [1])
Item
Irritability/Fussiness intensity
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Symptom intensity irritable mood
Code List
Irritability/Fussiness intensity
CL Item
Behavior as usual (0)
CL Item
Crying more than usual / no effect on normal activity (1)
CL Item
Crying more than usual / interferes with normal activity (2)
CL Item
Crying that cannot be comforted / prevents normal activity (3)
Item
Drowsiness intensity
integer
C0518690 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
Symptom intensity drowsiness
Code List
Drowsiness intensity
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Loss of appetite intensity
integer
C0518690 (UMLS CUI [1,1])
C1971624 (UMLS CUI [1,2])
Symptom intensity loss of appetite
Code List
Loss of appetite intensity
CL Item
Appetite as usual (0)
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
Item Group
General Symptoms
C0159028 (UMLS CUI-1)
Item
Symptom
text
C0159028 (UMLS CUI [1])
Local Symptom
Code List
Symptom
CL Item
Fever ([FE])
CL Item
Irritability/Fussiness ([IR])
CL Item
Drowsiness ([DR])
CL Item
Loss of appetite ([LO])
General symptoms continuous
Item
Ongoing after Day 6?
boolean
C0159028 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date in time last general symptoms
Item
Date of the last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
Item Group
Other General Symptoms
C0159028 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Other general symptoms description
Item
Description
text
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
Intensity
integer
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Vaccination local symptom intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Other general symptoms start date
Item
Start date
date
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Other general symptoms end date
Item
End date
date
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Other general symptoms continuous
Item
Other general symptoms continuing
boolean
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Date in time subject diary visit return patient information
Item
Please do not forgive to bring back the diary card on:
date
C0011008 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C1548100 (UMLS CUI [1,4])
Contact information hospitalisation person name
Item
In case of hospitalisation, please inform:
text
C1880174 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1547383 (UMLS CUI [1,3])
Contact information hospitalisation telephone number
Item
In case of hospitalisation, please inform:
integer
C1880174 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1515258 (UMLS CUI [1,3])
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