Influenza Clinical Trial
Official title:
Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/California/66/395 (H2N2)Influenza Vaccine
This is a phase I study to evaluate the safety of a vaccine to protect against influenza viruses of the H2N2 subtype. A total of 40 adults will be enrolled and receive two doses of vaccine or placebo one month apart.
The aim of this study is to evaluate the safety profile of two intranasal doses of LAIV
A/17/California/66/395 (H2N2) in healthy adults in Russia. A(H2N2) viruses which are
antigenically similar to the pandemic strain A/Singapore/1/57, continue to circulate in
domestic and wild bird populations, as confirmed by routine moni¬toring of avian influenza
viruses.
40 adults aged 18-40 will be enrolled. They will be randomized to receive vaccine or placebo.
Blood and urine will be collected during the week following each vaccination and before the
next vaccination to monitor safety. Blood samples will also be collected at several
timepoints to assess the volunteer's immune response to the vaccine. The total duration of
the study is 16 weeks for each volunteer.
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