Phase 3 Trial of Serbian Seasonal Influenza Vaccine

Phase 3 Completed 480 enrolled Institute of Virology, Vaccines and Sera, Torlak Comac Medical · collab PATH · collab World Health Organization · collab

RandomizedParallel-groupTriple-blindPrevention

Summary

A Phase 3, double-blind, randomized, placebo-controlled trial of a seasonal, trivalent, split, inactivated influenza vaccine produced by InstituteTorlak.

Timeline

Start: 2016-11-28
Primary completion: 2017-01-08
Completion: 2017-03-25

Publications

Stevanovic G, Obradovic A, Ristic S, Petrovic D, Milenkovic B, Mitrovic D, Vignjevic SF, Ilic K, Stoiljkovic V, Lavadinovic L, Pelemis M, Petrovic S, Vidmanic A, Popovic O, Eremic N, Sparrow E, Torelli G, Socquet M, Holt R, Ilieva-Borisova Y, Tang Y, Scorza FB, Flores J, Rathi N. Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a double blind, phase III randomized clinical trial in healthy Serbian adults. Ther Adv Vaccines Immunother. 2020 May 25;8:2515135520925336. doi: 10.1177/2515135520925336. eCollection 2020.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Seasonal trivalent split, inactivated influenza vaccine	Vaccine	15 ug	Intramuscular
Subject	Seasonal trivalent split, inactivated influenza vaccine	Vaccine	0.5 ml	Intramuscular

Phase 3 Trial of Serbian Seasonal Influenza Vaccine

Summary

Timeline

Publications

Drugs

Indications