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Table 5 Study schema for study group 4

From: The role of pre-existing cross-reactive antibodies in determining the efficacy of vaccination in humans: study protocol for a randomized controlled trial

  Visit 1 – screening (-21 to -1 days) Visit 2 - first vaccination (day 0) Visit 3 - 1 day after Visit 4 - 3 days after (+1 day) Visit 5 - 1 week after (±2 days) Visit 6 - 15 days after (+2 days) Visit 7 - 1 month after (±5 days) Visit 8 - 6 months after (±14 days)
   Pre-vaccination Post-vaccination (1 hour)  
Inform consent ×         
Medical history and demographics ×         
Physical examination ×   × × × × x × ×
Vital signsa × × × × × × x × ×
Haematology labsb ×         
Chemistry labs (liver, renal panelc) ×         
Dengue immunoglobulin Gd ×         
Urine pregnancy teste × ×        
Adverse eventsf × ×   ×    x   
Concomitant medications × ×   ×    x   
Blood sampling in relation to YF17D vaccination   ×g   × × ×   × ×
Assessment for clinical symptoms (local and general symptoms)    × × × × x   
  1. aVital signs include temperature (oral and tympanic allowed), blood pressure, pulse rate, and respiratory rate. bHematology labs include hemoglobin, red blood cell, white blood cell, hematocrit, platelet count, neutrophil, lymphocyte, monocyte, eosinophil, basophil. cLiver panel includes total protein, albumin, total bilirubin, alkaline phosphatase, ALT alanine transaminase, AST aspartate transaminase, gamma-glutamyl transpeptidase. Renal panel includes urea, sodium, potassium, chloride, bicarbonate, creatinine. dDengue immunoglobulin G will be tested by enzyme-linked immunosorbent assay. eFor females only. fClinical Trial Certificate Adverse Events version 4.0 will be used for grading. gFor third vaccination, pre-dose blood sample can be taken any time before dosing. YF, yellow fever.