CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 612 enrolled
Drug / intervention
Grippol® Quadri +2 morebiological
Likely dose
Grippol® Quadri 0.5 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03849560
NCT03849560Phase 3Completed
CompareCT.gov

A Multicenter, Double-Blind, Randomized, Parallel Group Study of Safety, Reactogenicity, Immunogenicity, and Efficacy of Quadrivalent Influenza Vaccine Grippol Quadri and Trivalent Influenza Vaccine Grippol Plus in Volunteers.

NPO Petrovax·interventional·Posted Feb 21, 2019·Updated Nov 4, 2024

In Brief

A Phase 3 clinical trial evaluating Grippol® Quadri, Grippol® Plus, trivalent (Yamagata lineage), and 1 other intervention for Influenza. Completed, enrolled 612 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesRussia
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 21, 2019
Enrollment StartNov 1, 2016
Primary CompletionJun 1, 2017
Study CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.4 years ago

Interventions

Grippol® Quadribiological

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).

Grippol® Plus, trivalent (Yamagata lineage)biological

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).

Grippol® Plus, trivalent (Victoria lineage)biological

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).