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

NCT03849560 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 612

Last updated 2024-11-04

Study results available
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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.

Conditions

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).

Sponsors & Collaborators

  • NPO Petrovax

    lead INDUSTRY

Principal Investigators

  • Natalia Chirun, PhD · NPO Petrovax

  • Dmitri Lioznov, PhD · 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.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-06-30
Completion
2017-08-31

Countries

  • Russia

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03849560 on ClinicalTrials.gov