Safety, Reactogenicity, Immunogenicity, Efficacy of Influenza Vaccines Grippol® Quadri and Grippol® Plus in Volunteers

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

612

Participants

Timeline

Start Date

November 30, 2016

Primary Completion Date

June 30, 2017

Study Completion Date

August 31, 2017

Conditions
Influenza
Interventions
BIOLOGICAL

Grippol® Quadri

Single intramuscular injection of 0.5 ml (1 dose) of vaccine Grippol® Quadri into the upper third of the outer surface of the shoulder (the deltoid muscle).

BIOLOGICAL

Grippol® Plus, trivalent (Yamagata lineage)

Single intramuscular injection of 0.5 ml (1 dose) of vaccine Grippol® Plus, trivalent (Yamagata lineage) into the upper third of the outer surface of the shoulder (the deltoid muscle).

BIOLOGICAL

Grippol® Plus, trivalent (Victoria lineage)

Single intramuscular injection of 0.5 ml (1 dose) of vaccine Grippol® Plus, trivalent (Victoria lineage) into the upper third of the outer surface of the shoulder (the deltoid muscle).

Trial Locations (3)

197022

"Federal State Budgetary Educational Institution of Higher Education First St. Petersburg State Medical University named after academician I.P. Pavlova of the Ministry of Health of the Russian Federation.", Saint Petersburg

"Federal State Budgetary Institution Children's Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency", Saint Petersburg

197376

Smorodintsev Research Institute of Influenza, Saint Petersburg

All Listed Sponsors
lead

NPO Petrovax

INDUSTRY

NCT03849560 - Safety, Reactogenicity, Immunogenicity, Efficacy of Influenza Vaccines Grippol® Quadri and Grippol® Plus in Volunteers | Biotech Hunter | Biotech Hunter