Cuba´s Soberana 02 Vaccine to Enter Phase-3

As many as 44,010 persons will volunteer from today in the clinical trial of Cuba´s Soberana 02 vaccine candidate that enters phase-3.

The Cuban public registry of clinical trials detailed on its website that in this phase-3 the objective is to assess efficacy, safety and immunogenicity of Soberana 02 vaccine.

In this last stage (phase-3), scientists will make a multicenter and adaptive study for parallel, randomized, placebo-controlled and double-blind groups.

As planned, two Finlay-FR-2 (Soberana 02) doses and a booster with Finlay-FR-1A (Soberana 01 A) will be administered.

Volunteers, in eight municipalities of Cuba´s capital, would be of 19 and 80 years of age.

The description said that those subjects with acute febrile or infectious disease in the seven days prior to the administration of the vaccine or at the time of its application will not be able to participate.

It also excludes individuals suffering from mental disorders, with a history of hypersensitivity to thiomerosal or to some of its formula components.