drugset / Trial / NCT03849560

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

NCT03849560 ↗

Phase 2/3 Completed 612 enrolled NPO Petrovax
RandomizedParallel-groupDouble-blindPrevention

Summary

The aim of the study to assess the safety, reactogenicity, immunogenicity, and efficacy of quadrivalent inactivated subunit influenza vaccine Grippol® Quadri (NPO Petrovax Pharm, LLC, Russia) versus trivalent inactivated polymer-subunit vaccine Grippol® Plus (NPO Petrovax Pharm, LLC, Russia) in subjects from 18 to 60 years old.

Timeline

Start
2016-11
Primary completion
2017-06
Completion
2017-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Grippol Quadri Vaccine 0.5 ml Intramuscular
Comparator Grippol® Plus, trivalent (Victoria lineage) Unknown 0.5 ml Intramuscular
Comparator Grippol® Plus, trivalent (Yamagata lineage) Unknown 0.5 ml Intramuscular

Indications