A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of GamEvac-Lyo

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

November 3, 2017

Primary Completion Date

November 30, 2018

Study Completion Date

December 31, 2018

Conditions
Healthy Volunteers
Interventions
BIOLOGICAL

GamEvac-Lyo (component A)

Biological: GamEvac-Lyo (vaccine) vaccination, single administration, component A

OTHER

Placebo

Placebo vaccination

BIOLOGICAL

GamEvac-Lyo (component B)

Biological: GamEvac-Lyo (vaccine) vaccination, single administration, component B

BIOLOGICAL

GamEvac-Lyo

Biological: GamEvac-Lyo (vaccine) vaccination, therapeutic scheme: the sequential introduction of components A and b with an interval of 21 days

Trial Locations (1)

Unknown

Research Institute of Influenza, Saint Petersburg

All Listed Sponsors
collaborator

Research Institute of Influenza, Sankt-Peterburg, Russian Federation

UNKNOWN

lead

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

OTHER

NCT03333538 - A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of GamEvac-Lyo | Biotech Hunter | Biotech Hunter