Table 2

Procedure/Observation	Screening	Days after vaccination							Day 21 ± 2 days
Procedure/Observation	Screening	0 (baseline)	2	3	4	5	6	7	Day 21 ± 2 days
Receiving informed consent	X
Monitoring of vital signs and symptoms		X^ab	X	X	X	X	X	X	X
Physical eX^amination		X^ab	X	X	X	X	X	X	X
Neurological eX^amination		X^a						X	X
Laboratory study:
Clinical and biochemical blood analysis	X	X^a						X	X
Tests for HIV, and hepatitis B and C Urinalysis		X^a						X	X
Urine test for pregnancy (women of reproductive age)		X^a							X
Electrocardiogram		X^a						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	X^a							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.