InfluenzaPhase 3NCT06385821
A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus
A Phase 3 study testing Grippol Quadrivalent and Grippol Plus in people with Influenza and Influenza A, run by NPO Petrovax at 14 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Influenza A, Influenza, Human
- What is being tested?
- Grippol Quadrivalent and Grippol Plus
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 824 participants
- Where
- 14 sitesRussia
- Study dates
- 21 Sep 2022to 9 Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Russia14 sites
Federal State Budgetary Research Institution "Russian research center of surgery named after academician B.V. Petrovsky"
Moscow, 119435
State Budgetary Healthcare Institution "Children's City Clinical Hospital No.9 named after G.N. Speransky of Moscow Healthcare Department"
Moscow, 123317
State Budgetary Health Institution of the Perm Territory "City Children's Clinical Polyclinic No. 5
Perm, 614066
Limited Liability Company "Clinic USI 4D"
Pyatigorsk, 357502
Limited Liability Company Medical technology
Saint Petersburg, 192148
St. Petersburg State Budgetary Health Institution "Children's City Polyclinic No. 45 of the Nevsky District"
Saint Petersburg, 193312
Limited Liability Company " Energiia Zdoroviya"
Saint Petersburg, 194156
Limited Liability Company PiterClinica
Saint Petersburg, 196158
Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases under the Federal Medical Biological Agency
Saint Petersburg, 197022
St. Petersburg State Budgetary Healthcare Institution City Polyclinic No.106 Children's Polyclinic Department No. 37
Saint Petersburg, 198328
State Budgetary Healthcare Institution of the Samara region "Samara Regional Children's Clinical Hospital named after N.N. Ivanova"
Samara, 443079
Limited Liability Company Center DNK-issledovaniy
Saratov, 410005
Federal State Budgetary Educational Institution of Higher Education "Tyumen State Medical University" of the Ministry of Healthcare of the Russian Federation
Tyumen, 625023
State Autonomous Healthcare Institution of the Sverdlovsk Region "Children's City Clinical Hospital No. 11"
Yekaterinburg, 620028
About this study
Official title: Multicenter, Double-blind, Randomized, Parallel Group Study to Evaluate the Immunogenicity, Reactogenicity and Safety of the Grippol® Quadrivalent Vaccine in Children Aged 6 Months to 5 Years (Inclusive)
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".
Read the detailed description
The main questions it aims to answer are:
- To compare the 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 "geometric mean antibody titers after vaccination"
- Evaluate the immunogenicity of the Grippol Quadrivalent vaccine and the Grippol plus vaccine according to the following indicators:
- Proportion of those vaccinated with seroconversion and geometric mean titer of antibodies to the fourth additional strain of compared vaccines
- Multiplicity of the increase in the geometric mean titer of antibodies to 4 strains of the influenza virus in paired sera of the hemagglutination inhibition reaction after vaccination in relation to the initial values of antibody titers
- Seroprotection (proportion (%) vaccinated with antibody titer ≥ 1:40 to 4 strains of influenza virus in paired sera of the hemagglutination inhibition reaction after vaccination)
- Evaluate the effectiveness of the Grippol Quadrivalent vaccine and the Grippol plus vaccine according to the following indicators:
- Incidence of Influenza and ARI (Month 1-Month 6 after vaccination)
- Severity and duration of reported cases of influenza and ARI, presence of complications
- Assess the reactogenicity of the Grippol Quadrivalent vaccine and the Grippol plus vaccine in children aged 6 months to 5 years (inclusive):
- Frequency and nature of general and local post-vaccination reactions (7-day follow-up period after vaccine administration)
- Assess the safety of Grippol Quadrivalent and Grippol Plus in children aged 6 months to 5 years (inclusive)
- Conditions
- Influenza, Influenza A, Influenza, Human, Influenza Type B, Flu, Influenza A H3N2
- Being tested
- Grippol Quadrivalent, Grippol Plus
- Keywords
- Vaccine, Influenza vaccine, acute respiratory infection
- Medical subject headings
- Influenza, Human, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grippol QuadrivalentBiological
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 PlusBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| Grippol Quadrivalent | Experimental | influenza quadrivalent inactivated subunit adjuvant vaccine Receives: Biological: Grippol Quadrivalent |
| Grippol Plus | Active comparator | influenza trivalent inactivated polymer-subunit vaccine Receives: Biological: Grippol Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- increase in antibody titer to influenza virus strains to ≥ 1:40 (with initial antibody titer < 1:10); or
- 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.
Measured: Baseline to Day 25±3
Secondary outcomes (9)
Geometric mean antibody titers
Geometric mean antibody titers after vaccination for three matching strains
Measured: Baseline to Day 25±3
Proportion of those vaccinated with seroconversion and geometric mean titer
Proportion of those vaccinated with seroconversion and geometric mean titer of antibodies to the fourth additional strain of compared vaccines
Measured: Baseline to Day 25±3
Multiplicity of the increase in the geometric mean titer
Multiplicity of the increase in the geometric mean titer of antibodies to 4 strains of the influenza virus in paired sera of the hemagglutination inhibition reaction after vaccination in relation to the initial values of antibody titers
Measured: Baseline to Day 25±3
Seroprotection
Seroprotection (proportion (%) vaccinated with antibody titer ≥ 1:40 to 4 strains of influenza virus in paired sera of the hemagglutination inhibition reaction after vaccination)
Measured: Baseline to Day 25±3
Incidence of influenza and acute respiratory infections (ARI)
- Incidence of influenza and ARI (Month 1 - Month 6 after vaccination)
Measured: Month 1-6
The severity and duration of registered cases of influenza and acute respiratory infections (ARI), the presence of complications
The severity and duration of registered cases of influenza and ARI, the presence of complications (Month 1 - Month 6 after vaccination)
Measured: Month 1 to Month 6
To assess the reactogenicity of the vaccine Grippol Quadrivalent and the vaccine Grippol plus
Frequency and nature of general and local post-vaccination reactions (7-day follow-up period after vaccine administration)
Measured: First 7 days after vaccination
Frequency and nature of SAEs
Frequency and nature of SAEs (Day 1-Month 6)
Measured: Baseline to month 6
Frequency and nature of medically attended AEs
Frequency and nature of medically attended AEs (Month 1-Month 6)
Measured: Baseline to month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start21 Sep 2022
- Primary completion15 Jun 2023
- Study completion9 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 824 participants (actual)
Sponsor and investigators
- Lead sponsor
- NPO Petrovax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385821
- Sponsor's protocol ID
- GriQv-ch-III-22
- Status last verified
- Nov 2023
- First submitted
- 4 Sep 2023
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double-blind, Randomized, Parallel Group Study to Evaluate the Immunogenicity, Reactogenicity and Safety of the Grippol® Quadrivalent Vaccine in Children Aged 6 Months to 5 Years (Inclusive)
- ClinicalTrials.gov ID
- NCT06385821
- Acronym / sponsor ID
- GriQv-ch-III-22
- Conditions
- Influenza, Influenza A, Influenza, Human, Influenza Type B, Flu, Influenza A H3N2
- Keywords
- Vaccine, Influenza vaccine, acute respiratory infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 824 participants (actual)
- Lead sponsor
- NPO PetrovaxIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 9 Oct 2023 (actual)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Detailed description
The main questions it aims to answer are:
- To compare the 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 "geometric mean antibody titers after vaccination"
- Evaluate the immunogenicity of the Grippol Quadrivalent vaccine and the Grippol plus vaccine according to the following indicators:
- Proportion of those vaccinated with seroconversion and geometric mean titer of antibodies to the fourth additional strain of compared vaccines
- Multiplicity of the increase in the geometric mean titer of antibodies to 4 strains of the influenza virus in paired sera of the hemagglutination inhibition reaction after vaccination in relation to the initial values of antibody titers
- Seroprotection (proportion (%) vaccinated with antibody titer ≥ 1:40 to 4 strains of influenza virus in paired sera of the hemagglutination inhibition reaction after vaccination)
- Evaluate the effectiveness of the Grippol Quadrivalent vaccine and the Grippol plus vaccine according to the following indicators:
- Incidence of Influenza and ARI (Month 1-Month 6 after vaccination)
- Severity and duration of reported cases of influenza and ARI, presence of complications
- Assess the reactogenicity of the Grippol Quadrivalent vaccine and the Grippol plus vaccine in children aged 6 months to 5 years (inclusive):
- Frequency and nature of general and local post-vaccination reactions (7-day follow-up period after vaccine administration)
- Assess the safety of Grippol Quadrivalent and Grippol Plus in children aged 6 months to 5 years (inclusive)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grippol Quadrivalent | Experimental | Biological: Grippol Quadrivalentinfluenza quadrivalent inactivated subunit adjuvant vaccine |
| Grippol Plus | Active comparator | Biological: Grippol Plusinfluenza trivalent inactivated polymer-subunit vaccine |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grippol QuadrivalentSolution 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 Quadrivalent |
| Grippol PlusSuspension 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 |
Primary outcome
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
Time frame: Baseline to Day 25±3
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.
9 secondary outcomes
Geometric mean antibody titers
Time frame: Baseline to Day 25±3
Proportion of those vaccinated with seroconversion and geometric mean titer
Time frame: Baseline to Day 25±3
Multiplicity of the increase in the geometric mean titer
Time frame: Baseline to Day 25±3
Seroprotection
Time frame: Baseline to Day 25±3
Incidence of influenza and acute respiratory infections (ARI)
Time frame: Month 1-6
The severity and duration of registered cases of influenza and acute respiratory infections (ARI), the presence of complications
Time frame: Month 1 to Month 6
To assess the reactogenicity of the vaccine Grippol Quadrivalent and the vaccine Grippol plus
Time frame: First 7 days after vaccination
Frequency and nature of SAEs
Time frame: Baseline to month 6
Frequency and nature of medically attended AEs
Time frame: Baseline to month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Grippol Quadrivalent and Grippol Plus in people with Influenza and Influenza A, run by NPO Petrovax at 14 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline to Day 25±3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.