ID
42497
Descrizione
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). For all subjects enrolled, please complete the study conclusion form. Study conclusion should be documented subsequently to clinical visit 7 in separate forms for the double-blind and the single-blind phase respectively. The 'Status of Treatment Blind' item group only needs to be completed within the form for the double-blind phase. Note that informed consent has to be obtained prior to any study procedure.
collegamento
https://clinicaltrials.gov/ct2/show/study/NCT00380393
Keywords
versioni (1)
- 01/08/21 01/08/21 -
Titolare del copyright
GlaxoSmithKline
Caricato su
1 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.
Efficacy of P. Falciparum Vaccine Against Malaria in Children NCT00380393
Study Conclusion
- StudyEvent: ODM
Descrizione
Occurrence of Serious Adverse Events
Alias
- UMLS CUI-1
- C1519255
Descrizione
Serious adverse event during clinical trial period
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
Descrizione
Serious adverse event during clinical trial period count specification
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
- UMLS CUI [1,4]
- C0750480
- UMLS CUI [1,5]
- C1521902
Descrizione
Status of Treatment Blind, only to be completed for the double-blind phase questionnaire
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Descrizione
Only to be completed for the double-blind phase questionnaire.
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
Descrizione
Subject unblinding event record date
Tipo di dati
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Descrizione
Complete Non-Serious Adverse Event section or a Serious Adverse Event report as appropriate.
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205225
Descrizione
Subject unblinding event record other reason to specify
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Descrizione
Elimination Criteria
Alias
- UMLS CUI-1
- C0680251
Descrizione
Elimination criteria during clinical trial period
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
Descrizione
Elimination criteria to specify
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1521902
Descrizione
Patient withdrawn from trial
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0422727
Descrizione
Please tick one box only. If serious adverse event [SAE], please complete and submit SAE report. If non-serious adverse event [AEX], please complete non-serious adverse event section. Note that non-serious adverse event [AEX] is only selectable as an option when completing the questionnaire for the double-blind phase.
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205225
Descrizione
Death-related serious adverse event number to specify
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0237753
- UMLS CUI [1,4]
- C1521902
Descrizione
Serious adverse event number to specify
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1521902
Descrizione
Or specify solicited AE code in the following item. Note that non-serious adverse events are only specifiable when completing the questionnaire for the double-blind phase.
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1521902
Descrizione
Or specify non-serious adverse event number in the previous item. Note that non-serious adverse events are only specifiable when completing the questionnaire for the double-blind phase.
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1517001
- UMLS CUI [1,3]
- C0805701
- UMLS CUI [1,4]
- C1521902
Descrizione
Protocol violation to specify
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C1521902
Descrizione
Withdrawal other reason to specify
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Descrizione
Withdrawal decision maker
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
Descrizione
Withdrawal date of last contact
Tipo di dati
date
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0805839
Descrizione
If no, please give details in Adverse Events section.
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1142435
- UMLS CUI [1,3]
- C0805839
Descrizione
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Alias
- UMLS CUI-1
- C2346576
Descrizione
Investigator signature
Tipo di dati
text
Alias
- UMLS CUI [1]
- C2346576
Descrizione
Investigator name
Tipo di dati
text
Alias
- UMLS CUI [1]
- C2826892
Descrizione
Investigator signature date
Tipo di dati
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Study Conclusion
- StudyEvent: ODM
C2603343 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
C2347038 (UMLS CUI-2)
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C0237753 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C1517001 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C0679006 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,2])
C1142435 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])