ID

42537

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. Solicited and unsolicited adverse events form should be documented following vaccinations at visit 2 (dose 1), visit 4 (dose 2) and visit 5 (dose 3) whenever the subject experiences any of the listed signs/symptoms during the solicited period or any serious or non-serious unsolicited adverse events within 30 days post-vaccination. If any of these adverse events meets the protocol definition of serious, please complete a Serious Adverse Event report and fax to GSK Biologicals Study Contact for SAE reporting within 24 hours. Note that informed consent has to be obtained prior to any study procedure.

Link

https://clinicaltrials.gov/ct2/show/NCT00307021

Stichworte

Versionen (1)
  1. 24.08.21 24.08.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

24. August 2021

DOI

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Lizenz

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Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021

Englisch

Solicited and Unsolicited Adverse Events

1 Formulare  
Administrative Documentation
Beschreibung

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Vaccine dose number
Beschreibung

Vaccine dose number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1115464
UMLS CUI [1,2]
C0042210
Date of visit/vaccination
Beschreibung

Visit date | vaccination date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C0011008
Solicited Adverse Events Local Symptoms
Beschreibung

Solicited Adverse Events Local Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1517001
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
UMLS CUI-5
C0150312
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Beschreibung

If [Y] Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all respective items in the following two item groups. If any of these adverse events meets the protocol definition of serious, please complete a Serious Adverse Event report and fax to GSK Biologicals Study Contact for SAE reporting within 24 hours.

Datentyp

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C2700396
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0687676
Has the subject experienced swelling at the administration site during the solicited period?
Beschreibung

If yes is ticked, please complete all respective items in the following two item groups.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
UMLS CUI [1,3]
C0150312
Has the subject experienced pain at the administration site during the solicited period?
Beschreibung

If yes is ticked, please complete all respective items in the following two item groups.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2700396
UMLS CUI [1,3]
C0150312
Solicited Adverse Events Local Symptoms
Beschreibung

Solicited Adverse Events Local Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1517001
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
UMLS CUI-5
C2348235
Day
Beschreibung

If symptom has been ticked in previous item group, please complete all respective items in this item group for day 0 to day 6 post vaccination.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0042196
Swelling, size (mm)
Beschreibung

Only to be completed if swelling has been selected in previous item group.

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Pain intensity
Beschreibung

Please indicate the intensity for solicited symptoms (pain). Only to be completed if pain has been selected in previous item group.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C2700396
Solicited Adverse Events Local Symptoms
Beschreibung

Solicited Adverse Events Local Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1517001
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
UMLS CUI-5
C0449238
Local Symptom
Beschreibung

If symptom details have been quantified in the previous item group, please select the respective symptom and complete all items in this item group.

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Did the patient experience ongoing local symptoms after day 6?
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
Date of the last day of symptoms
Beschreibung

Date in time last symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Solicited Adverse Events General Symptoms
Beschreibung

Solicited Adverse Events General Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1517001
UMLS CUI-3
C0159028
UMLS CUI-4
C0150312
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Beschreibung

If [Y] Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all respective items in the following two item groups. If any of these adverse events meets the protocol definition of serious, please complete a Serious Adverse Event report and fax to GSK Biologicals Study Contact for SAE reporting within 24 hours.

Datentyp

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0042196
Has the subject experienced fever [FE] during the solicited period?
Beschreibung

Fever is defined as axillary temperature > 37.5°C, oral temperature > 37.5°C, or rectal temperature > 38.0°C. If yes is ticked, please complete all respective items in the following two item groups.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0150312
Body temperature measurement site
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0449687
Has the subject experienced irritability/fussiness [IR] during the solicited period?
Beschreibung

If yes is ticked, please complete all respective items in the following two item groups.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0150312
Has the subject experienced drowsiness [DR] during the solicited period?
Beschreibung

If yes is ticked, please complete all respective items in the following two item groups.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0150312
Has the subject experienced loss of appetite [LO] during the solicited period?
Beschreibung

If yes is ticked, please complete all respective items in the following two item groups.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0150312
Solicited Adverse Events General Symptoms
Beschreibung

Solicited Adverse Events General Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1517001
UMLS CUI-3
C0159028
UMLS CUI-4
C2348235
Day
Beschreibung

If symptom has been ticked in previous item group, please complete all respective items in this item group for day 0 to day 6 post vaccination.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0042196
Body temperature
Beschreibung

Only to be completed if Fever [FE] has been selected in previous item group.

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0449687
°C
Body temperature not taken
Beschreibung

Only to be completed if [FE] has been selected in previous item group.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1272696
Irritability/Fussiness intensity
Beschreibung

Only to be completed if Irritability/Fussiness [IR] has been selected in previous item group. Please indicate the intensity for solicited symptoms (irritability / fussiness).

Datentyp

integer

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

Only to be completed if drowsiness [DR] has been selected in previous item group. Please indicate the intensity for solicited symptoms (drowsiness).

Datentyp

integer

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

Only to be completed if loss of appetite [LO] has been selected in previous item group. Please indicate the intensity for solicited symptoms (loss of appetite).

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1971624
Solicited Adverse Events General Symptoms
Beschreibung

Solicited Adverse Events General Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1517001
UMLS CUI-3
C0159028
UMLS CUI-4
C0449238
Symptom
Beschreibung

If symptom details have been quantified in the previous item group, please select the respective symptom and complete all items in this item group.

Datentyp

text

Alias
UMLS CUI [1]
C0159028
Did the patient experience ongoing symptoms after day 6?
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]
C0549178
Date of the last day of symptoms
Beschreibung

Date in time last symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Causality?
Beschreibung

Please indicate the suspected causality between the vaccination and the selected symptom. Note that for Fever [FE], any Grade 3 temperature not related to vaccination should be entered as Causality “NO”. Alternative reasoning should be given in the following item.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0015967
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0022107
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0013144
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C1971624
Please describe an alternative reason for any Grade 3 temperature not related to vaccination (temperature > 39°C; Causality “NO”).
Beschreibung

Note: This item should only be completed if fever (>39°C) non-related to vaccination (Causality “NO” in previous item) has occured.

Datentyp

text

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0015967
Unsolicited Adverse Events
Beschreibung

Unsolicited Adverse Events

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C4055646
Has the subject experienced any serious or non-serious unsolicited adverse events within 30 days post-vaccination?
Beschreibung

If [Y] Yes, fill in the Non-Serious Adverse Event section or Serious Adverse Event report, as appropriate.

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C4055646
UMLS CUI [1,3]
C0687676
UMLS CUI [1,4]
C0042196
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C4055646
UMLS CUI [2,3]
C0687676
UMLS CUI [2,4]
C0042196
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Ähnliche Modelle

Solicited and Unsolicited Adverse Events

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (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 (visit 2) (1)
(Comment:en)
CL Item
dose 2 (visit 4) (2)
(Comment:en)
CL Item
dose 3 (visit 5) (3)
(Comment:en)
Visit date | vaccination date
Item
Date of visit/vaccination
date
C1320303 (UMLS CUI [1])
C0042196 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Item Group
Solicited Adverse Events Local Symptoms
C0877248 (UMLS CUI-1)
C1517001 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
C0150312 (UMLS CUI-5)
Item
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C0037088 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Code List
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available ([U])
CL Item
No Vaccine administered ([NA])
CL Item
No ([N])
CL Item
Yes ([Y])
Swelling injection site
Item
Has the subject experienced swelling at the administration site during the solicited period?
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
Pain injection site
Item
Has the subject experienced pain at the administration site during the solicited period?
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
Item Group
Solicited Adverse Events Local Symptoms
C0877248 (UMLS CUI-1)
C1517001 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
C2348235 (UMLS CUI-5)
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
Solicited Adverse Events Local Symptoms
C0877248 (UMLS CUI-1)
C1517001 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
C0449238 (UMLS CUI-5)
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
Did the patient experience ongoing local symptoms 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
Solicited Adverse Events General Symptoms
C0877248 (UMLS CUI-1)
C1517001 (UMLS CUI-2)
C0159028 (UMLS CUI-3)
C0150312 (UMLS CUI-4)
Item
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C0037088 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Code List
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available ([U])
CL Item
No Vaccine administered ([NA])
CL Item
No ([N])
CL Item
Yes ([Y])
Fever [FE]
Item
Has the subject experienced fever [FE] during the solicited period?
boolean
C0015967 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
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 (preferred) ([A])
CL Item
Oral ([O])
CL Item
Rectal ([R])
Irritability/Fussiness [IR]
Item
Has the subject experienced irritability/fussiness [IR] during the solicited period?
boolean
C0022107 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Drowsiness [DR]
Item
Has the subject experienced drowsiness [DR] during the solicited period?
boolean
C0013144 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Loss of appetite [LO]
Item
Has the subject experienced loss of appetite [LO] during the solicited period?
boolean
C1971624 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Item Group
Solicited Adverse Events General Symptoms
C0877248 (UMLS CUI-1)
C1517001 (UMLS CUI-2)
C0159028 (UMLS CUI-3)
C2348235 (UMLS CUI-4)
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 [1,1])
C0449687 (UMLS CUI [1,2])
Body temperature not done
Item
Body temperature not taken
boolean
C0005903 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item
Irritability/Fussiness intensity
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Irritability/Fussiness intensity
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
Solicited Adverse Events General Symptoms
C0877248 (UMLS CUI-1)
C1517001 (UMLS CUI-2)
C0159028 (UMLS CUI-3)
C0449238 (UMLS CUI-4)
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])
Symptoms continuous
Item
Did the patient experience ongoing symptoms after day 6?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
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])
Etiology aspects fever | irritable mood | drowsiness | loss of appetite
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0022107 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0013144 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C1971624 (UMLS CUI [4,2])
Etiology aspects fever
Item
Please describe an alternative reason for any Grade 3 temperature not related to vaccination (temperature > 39°C; Causality “NO”).
text
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item Group
Unsolicited Adverse Events
C0877248 (UMLS CUI-1)
C4055646 (UMLS CUI-2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within 30 days post-vaccination?
text
C1519255 (UMLS CUI [1,1])
C4055646 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
C1518404 (UMLS CUI [2,1])
C4055646 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C0042196 (UMLS CUI [2,4])
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within 30 days post-vaccination?
CL Item
Information not available ([U])
CL Item
No Vaccine administered ([NA])
CL Item
No ([N])
CL Item
Yes ([Y])
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