A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus

PHASE3CompletedINTERVENTIONAL
Enrollment

824

Participants

Timeline

Start Date

September 21, 2022

Primary Completion Date

June 15, 2023

Study Completion Date

October 9, 2023

Conditions
InfluenzaInfluenza AInfluenza, HumanInfluenza Type BFluInfluenza A H3N2Influenza A H1N1Influenza EpidemicFlu, HumanAcute Respiratory InfectionVaccine Reaction
Interventions
BIOLOGICAL

Grippol Quadrivalent

Solution for intramuscular and subcutaneous administration, 0.5 ml/dose. Children from 36 months to 5 years - in the upper third of the outer surface of the shoulder intramuscularly (in the deltoid muscle) at a dose of 0.5 ml once (Day 1). Children from 6 to 35 months - in the anterolateral surface of the thigh intramuscularly 0.25 ml twice with an interval of 3-4 weeks (Day 1, Day 25±3).

BIOLOGICAL

Grippol Plus

Suspension for intramuscular and subcutaneous administration, 0.5 ml/dose. Children from 36 months to 5 years - in the upper third of the outer surface of the shoulder intramuscularly (in the deltoid muscle) at a dose of 0.5 ml once (Day 1). Children from 6 to 35 months - in the anterolateral surface of the thigh intramuscularly, 0.25 ml twice with an interval of 3-4 weeks (Day 1, Day 25±3).

Trial Locations (14)

119435

"Federal State Budgetary Research Institution Russian research center of surgery named after academician B.V. Petrovsky", Moscow

123317

"State Budgetary Healthcare Institution Children's City Clinical Hospital No.9 named after G.N. Speransky of Moscow Healthcare Department", Moscow

192148

Limited Liability Company Medical technology, Saint Petersburg

193312

"St. Petersburg State Budgetary Health Institution Children's City Polyclinic No. 45 of the Nevsky District", Saint Petersburg

194156

"Limited Liability Company Energiia Zdoroviya", Saint Petersburg

196158

Limited Liability Company PiterClinica, Saint Petersburg

197022

Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases under the Federal Medical Biological Agency, Saint Petersburg

198328

St. Petersburg State Budgetary Healthcare Institution City Polyclinic No.106 Children's Polyclinic Department No. 37, Saint Petersburg

357502

"Limited Liability Company Clinic USI 4D", Pyatigorsk

410005

Limited Liability Company Center DNK-issledovaniy, Saratov

443079

"State Budgetary Healthcare Institution of the Samara region Samara Regional Children's Clinical Hospital named after N.N. Ivanova", Samara

614066

"State Budgetary Health Institution of the Perm Territory City Children's Clinical Polyclinic No. 5", Perm

620028

"State Autonomous Healthcare Institution of the Sverdlovsk Region Children's City Clinical Hospital No. 11", Yekaterinburg

625023

"Federal State Budgetary Educational Institution of Higher Education Tyumen State Medical University of the Ministry of Healthcare of the Russian Federation", Tyumen

All Listed Sponsors
lead

NPO Petrovax

INDUSTRY