Healthy Volunteers Clinical Trial
Official title:
A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of Medicinal Product With a Period of Open Safety Assessment in Two Modes of Administration, in Healthy Volunteers
The aim of the present study is at the first stage: a comparative assessment of the safety of the two methods of vaccine administration, at the second - an assessment of the safety and state of post-vaccination immunity at different times after vaccination
In the first stage estimate of safety of vaccine after its single administration to the nasal
cavity by the drip method or by spray - dispenser during the period of observation in 30 days
with the participation of 24 volunteers, divided into 2 groups of 12 people for each method
of administration
After interim analysis of safety data is subject to the consent of the local ethics Committee
of the Research Centre about the possibility of further studies of the drug - will be started
the second phase of the study, which, along with continued security research, provides the
definition of the parameters of immunogenicity of the study drug. The second phase of the
study will included 200 participants, including 100 people will receive the study drug and
100 will be a control group of observation - that is, will get a placebo.
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