Influenza Clinical Trial
Official title:
A Phase 3 Double Blinded, Randomized, Placebo- Controlled Study to Examine the Safety and Immunogenicity of a Seasonal Trivalent Split Inactivated Influenza Vaccine Produced by Institute Torlak in 18-65 Year Old Volunteers in Serbia
A Phase 3, double-blind, randomized, placebo-controlled trial of a seasonal, trivalent, split, inactivated influenza vaccine produced by InstituteTorlak.
This is a phase 3, double-blind, randomized, placebo- controlled trial with two groups of
participants to receive seasonal trivalent split, inactivated influenza vaccine (A/H1N1;
A/H3N2 and B) or placebo (phosphate buffered saline). A total of about 480 healthy male and
female adults 18 through 65 years of age; 320 participants will be randomized to receive
vaccine and160 will receive placebo (a 2:1 ratio). At least 25% of the participants (N=120)
will be >/= 45 years of age (80 vaccine and 40 placebo recipients).
Safety will be assessed in all participants through Day 91. Immunogenicity will be assessed
in serum samples obtained at baseline and 21 days after vaccination in a subset of at least
100 individuals randomized to study vaccine and 50 placebo recipients.
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