ID
42522
Descrição
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). Definition of Serious Adverse Events (SAE): A serious adverse event (SAE) is any untoward medical occurrence that (a) results in death, (b) is life-threatening, (c) requires hospitalization or prolongation of existing hospitalization, (d) results in disability/incapacity, or (e) is a congenital anomaly/birth defect in the offspring of a study subject. Also see item descriptions for additional specification. Instructions for reporting Serious Adverse Events (SAE): Please report any serious adverse event (SAE) as specified in the study protocol by filling in this form. Serious Adverse Events (SAEs) related to study participation (e.g. procedures, invasive tests, change from existing therapy) or SAEs related to concurrent medication will be collected and recorded from the time the subject consents to participate in the study. For all other SAEs, the standard time period for collecting and recording SAEs will begin from the administration of the first dose of vaccine / placebo / comparator and will end minimum 30 days (ref to protocol) following administration of the last dose of vaccine / placebo / comparator for each subject. (1) Complete this form for each Serious Adverse Event as fully and accurately as possible in order to allow the safety department to make an assessment of the initially reported information and to minimize the time spent dealing with data queries. Ensure that all information on the SAE pages is consistent with information given on CRF pages: * Demography * General Medical History / Physical Examination * Vaccine administration page(s) (for administered doses) * Medication * Concomitant Vaccination (2) Sign and date below section 11 and section 12. Complete section 12 of the SAE form if needed only. (3) Send the SAE form to: * The GSK Biologicals study contact. Refer to protocol for contact name and number. * In the event of a death determined by the investigator to be related to the vaccination, sending of the fax must be accompanied by phone call to the study contact for reporting SAEs. The SAE form must be sent to GlaxoSmithKline within 24 hours of becoming aware of these events. (4) The Serious Adverse Event (SAE) report must be checked for final assessment at the end of the study. Note that informed consent has to be obtained prior to any study procedure.
Link
https://clinicaltrials.gov/ct2/show/study/NCT00380393
Palavras-chave
Versões (2)
- 17/08/2021 17/08/2021 -
- 17/08/2021 17/08/2021 -
Titular dos direitos
GlaxoSmithKline
Transferido a
17 août 2021
DOI
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Licença
Creative Commons BY-NC 4.0
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Efficacy of P. Falciparum Vaccine Against Malaria in Children NCT00380393
Serious Adverse Event Report
- StudyEvent: ODM
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Serious Adverse Event Report
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