Procedure/Observation Screening Days after vaccination Day 21 ± 2 days
0
(baseline)
2 3 4 5 6 7
Receiving informed consent X                
Monitoring of vital signs and symptoms   Xab X X X X X X X
Physical eXamination   Xab X X X X X X X
Neurological eXamination   Xa           X X
Laboratory study:                  
Clinical and biochemical blood analysis X Xa           X X
Tests for HIV, and hepatitis B and C Urinalysis   Xa           X X
Urine test for pregnancy (women of reproductive age)   Xa             X
Electrocardiogram   Xa           X X
Introduction of the studied preparation   X              
Sampling for the assessment of immune response                  
Analysis of antibody titers in blood serum using the HIA X Xa             X
Monitoring of adverse reactions and concomitant treatment   X----------------------------------------X
a Before vaccination. b At 20 minutes and 2 hours after vaccination.
Table 2: Regulation of the phase I clinical study of the Refluvac® vaccine.