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 |