ID
42537
Descrizione
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.
collegamento
https://clinicaltrials.gov/ct2/show/NCT00307021
Keywords
versioni (1)
- 24/08/21 24/08/21 -
Titolare del copyright
GlaxoSmithKline
Caricato su
24 agosto 2021
DOI
Per favore, per richiedere un accesso.
Licenza
Creative Commons BY-NC 4.0
Commenti del modello :
Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.
Commenti del gruppo di articoli per :
Commenti dell'articolo per :
Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.
Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021
Solicited and Unsolicited Adverse Events
- StudyEvent: ODM
Descrizione
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
Descrizione
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.
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C2700396
- UMLS CUI [1,3]
- C0042196
- UMLS CUI [1,4]
- C0687676
Descrizione
If yes is ticked, please complete all respective items in the following two item groups.
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C2700396
- UMLS CUI [1,3]
- C0150312
Descrizione
If yes is ticked, please complete all respective items in the following two item groups.
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C2700396
- UMLS CUI [1,3]
- C0150312
Descrizione
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
Descrizione
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.
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C0042196
Descrizione
Only to be completed if swelling has been selected in previous item group.
Tipo di dati
integer
Unità di misura
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Descrizione
Please indicate the intensity for solicited symptoms (pain). Only to be completed if pain has been selected in previous item group.
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C2700396
Descrizione
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
Descrizione
If symptom details have been quantified in the previous item group, please select the respective symptom and complete all items in this item group.
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Descrizione
If yes, please indicate the date of the last day of symptoms in the following item.
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2700396
- UMLS CUI [1,3]
- C0549178
Descrizione
Date in time last symptoms
Tipo di dati
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Descrizione
Solicited Adverse Events General Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C1517001
- UMLS CUI-3
- C0159028
- UMLS CUI-4
- C0150312
Descrizione
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.
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C0042196
Descrizione
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.
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C0150312
Descrizione
Please consider axillary measurement [A] to be the preferable route.
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0449687
Descrizione
If yes is ticked, please complete all respective items in the following two item groups.
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0150312
Descrizione
If yes is ticked, please complete all respective items in the following two item groups.
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0150312
Descrizione
If yes is ticked, please complete all respective items in the following two item groups.
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0150312
Descrizione
Solicited Adverse Events General Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C1517001
- UMLS CUI-3
- C0159028
- UMLS CUI-4
- C2348235
Descrizione
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.
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C0042196
Descrizione
Only to be completed if Fever [FE] has been selected in previous item group.
Tipo di dati
float
Unità di misura
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0449687
Descrizione
Only to be completed if [FE] has been selected in previous item group.
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1272696
Descrizione
Only to be completed if Irritability/Fussiness [IR] has been selected in previous item group. Please indicate the intensity for solicited symptoms (irritability / fussiness).
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Descrizione
Only to be completed if drowsiness [DR] has been selected in previous item group. Please indicate the intensity for solicited symptoms (drowsiness).
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0013144
Descrizione
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).
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1971624
Descrizione
Solicited Adverse Events General Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C1517001
- UMLS CUI-3
- C0159028
- UMLS CUI-4
- C0449238
Descrizione
If symptom details have been quantified in the previous item group, please select the respective symptom and complete all items in this item group.
Tipo di dati
text
Alias
- UMLS CUI [1]
- C0159028
Descrizione
If yes, please indicate the date of the last day of symptoms in the following item.
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
Descrizione
Date in time last symptoms
Tipo di dati
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Descrizione
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.
Tipo di dati
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
Descrizione
Note: This item should only be completed if fever (>39°C) non-related to vaccination (Causality “NO” in previous item) has occured.
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C0015967
Descrizione
Unsolicited Adverse Events
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C4055646
Descrizione
If [Y] Yes, fill in the Non-Serious Adverse Event section or Serious Adverse Event report, as appropriate.
Tipo di dati
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
Similar models
Solicited and Unsolicited Adverse Events
- StudyEvent: ODM
C0042210 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C1517001 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
C0150312 (UMLS CUI-5)
C2700396 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C2700396 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
C1517001 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
C2348235 (UMLS CUI-5)
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])
C1517001 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
C0449238 (UMLS CUI-5)
C2700396 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C1517001 (UMLS CUI-2)
C0159028 (UMLS CUI-3)
C0150312 (UMLS CUI-4)
C0687676 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0150312 (UMLS CUI [1,2])
C0449687 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,2])
C1517001 (UMLS CUI-2)
C0159028 (UMLS CUI-3)
C2348235 (UMLS CUI-4)
C0687676 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0449687 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,2])
C1517001 (UMLS CUI-2)
C0159028 (UMLS CUI-3)
C0449238 (UMLS CUI-4)
C0549178 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
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])
C0015967 (UMLS CUI [1,2])
C4055646 (UMLS CUI-2)
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])