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

NCT06385821 | Completed Phase 3 DMC

• 1 other identifier: GriQv-ch-III-22
• Study Type: interventional
• Target: 824
• Locations: 1 country
• Sites: 14

Brief Summary

The goal of this clinical study is to prove the no less immunogenicity of the Grippol Quadrivalent vaccine compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three identical strains of the compared vaccines in terms of the "proportion of vaccinated with seroconversion in paired sera of the hemagglutination inhibition reaction obtained before and after vaccination".

Conditions

Influenza; Influenza A; Influenza, Human; Influenza Type B; Flu; Influenza A H3N2; Influenza A H1N1; Influenza Epidemic; Flu, Human; Acute Respiratory Infection; Vaccine Reaction

Keywords

Vaccine; Influenza vaccine; acute respiratory infection

Outcome Measures

Primary Outcomes (1)

• To prove non-inferior immunogenicity of the Grippol Quadrivalent vaccine when compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three matching strains of the compared vaccines

  Proportion of vaccinated seroconverters in paired hemagglutination inhibition test sera obtained before and after vaccination Seroconversion is defined as: 1. increase in antibody titer to influenza virus strains to ≥ 1:40 (with initial antibody titer \< 1:10); or 2. an increase in antibody titer by 4 or more times compared to the initial titer (with an initial antibody titer ≥ 1:10) in paired sera RTGA after vaccination. The initial antibody titer will be the titers of antibodies to influenza virus antigens in the hemagglutination inhibition reaction obtained during screening. Post-vaccination titres will be those obtained on Day 25±3 after a single dose of vaccine in children 36 months to 5 years of age or a second dose of vaccine in children 6 to 35 months of age.

  Baseline to Day 25±3

Secondary Outcomes (9)

• Geometric mean antibody titers

  Baseline to Day 25±3

• Proportion of those vaccinated with seroconversion and geometric mean titer

  Baseline to Day 25±3

• Multiplicity of the increase in the geometric mean titer

  Baseline to Day 25±3

• Seroprotection

  Baseline to Day 25±3

• Incidence of influenza and acute respiratory infections (ARI)

  Month 1-6

Study Arms (2)

Grippol Quadrivalent

EXPERIMENTAL

influenza quadrivalent inactivated subunit adjuvant vaccine

Biological: Grippol Quadrivalent

Grippol Plus

ACTIVE COMPARATOR

influenza trivalent inactivated polymer-subunit vaccine

Biological: Grippol Plus

Interventions

Grippol Quadrivalent BIOLOGICAL

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).

Grippol Quadrivalent

Grippol Plus BIOLOGICAL

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).

Grippol Plus

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male and female children aged 6 months to 5 years inclusive at the time of vaccination.
• Availability of Informed consent to participate in the study, signed by one of the parents.
• The diagnosis is "healthy", established according to standard clinical, laboratory and instrumental methods of examination carried out at screening, according to the assessment of the researcher, as well as anamnesis data (absence of acute and chronic diseases of the respiratory, cardiovascular, nervous systems, dysfunction liver or kidneys).
• Negative result of a rapid test for SARS-CoV-2 antigen at screening.
• For children aged 6 to 11 months inclusive: children born at gestational age ≥37 weeks weighing ≥2.5 kg.
• Parental consent to cooperate in good faith with the investigator and center staff, attend scheduled visits, complete the self-monitoring diary, and follow the protocol.

You may not qualify if:

• Vaccination with any influenza vaccine within the previous 6 months. Vaccination with other vaccines, according to the national vaccination schedule, is allowed no later than 30 days before the introduction of the study vaccine, and no earlier than 30 days after the administration of the study vaccines.
• Participation in a clinical trial of a vaccine, medicinal product, or medical device less than 30 days prior to screening.
• Hypersensitivity to any of the components of the studied vaccines or severe post-vaccination complications to any vaccine in history.
• The presence at the time of screening of acute infectious diseases of any localization, or the presence of a history of acute infectious and non-infectious diseases less than 14 days before screening.
• Body temperature in the armpit ≥37.0°C at screening or before the introduction of the vaccine.
• History of significant chronic diseases, such as malignant neoplasms or blood diseases, autoimmune diseases, insulin-dependent diabetes mellitus, chronic diseases of the lungs, liver or kidneys, cardiovascular, nervous systems, secondary, primary and induced immunodeficiency, HIV- infections, as well as other significant, according to the researcher, diseases.
• A history of seizures or a progressive neurological disease.
• History of Guillain-Barré syndrome (post-infectious demyelinating polyradiculoneuropathy of autoimmune etiology).
• Use of antipyretics, including non-steroidal anti-inflammatory drugs less than 24 hours before screening and vaccination; antibacterial drugs of systemic action - less than 72 hours before screening and vaccination; anticoagulants - less than 3 weeks before screening and vaccination; immunoglobulins, blood products - less than 3 months before screening and vaccination; long-term use of systemic corticosteroids (prednisolone or equivalent for more than 2 consecutive weeks) - less than 3 months before vaccination screening.
• Surgery performed less than 3 months prior to screening.
• Children of research team members or research facility staff involved in this clinical trial.
• Orphans, children left without parental care.
• Any other medical or social condition that, in the opinion of the investigator, precludes the participation of the child in this study.

Sponsors & Collaborators

• NPO Petrovax: lead

Study Sites (14)

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

Moscow, 119435, Russia

Location

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

Moscow, 123317, Russia

Location

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

Perm, 614066, Russia

Location

Limited Liability Company "Clinic USI 4D"

Pyatigorsk, 357502, Russia

Location

Limited Liability Company Medical technology

Saint Petersburg, 192148, Russia

Location

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

Saint Petersburg, 193312, Russia

Location

Limited Liability Company " Energiia Zdoroviya"

Saint Petersburg, 194156, Russia

Location

Limited Liability Company PiterClinica

Saint Petersburg, 196158, Russia

Location

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

Saint Petersburg, 197022, Russia

Location

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

Saint Petersburg, 198328, Russia

Location

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

Samara, 443079, Russia

Location

Limited Liability Company Center DNK-issledovaniy

Saratov, 410005, Russia

Location

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

Tyumen, 625023, Russia

Location

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

Yekaterinburg, 620028, Russia

Location

MeSH Terms

Conditions

Influenza, Human; Orthomyxoviridae Infections

Interventions

Grippol

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: April 26, 2024
• Study Start: September 21, 2022
• Primary Completion: June 15, 2023
• Study Completion: October 9, 2023
• Last Updated: April 26, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (14)