InfectionsPhase 3NCT06834100

Assessment of Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE in Comparison With the Reference Drug

A Phase 3 study testing polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y in people with Infections and Meningococcal, run by NPO Petrovax at 17 sites in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Assessment of immunogenicity, reactogenicity and safety of GNG-DE in comparison with the reference drug Read more about this study

Who is it for?: Ages 3 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Infections, Meningococcal
What is being tested?: polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 17 sitesRussia
Study dates: 12 Feb 2025to 31 Dec 2025
Phase: Phase 3
Are there results?: Not yet: the study is under way

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 3 to 55 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Male and female subjects aged 3-55 years old inclusive at the time of screening beginning.
Availability of a signed Volunteer Informed Consent Form (Volunteer Information Sheet, VIS) (for participants aged 7-55 years inclusive) and/or the parent/adoptive parent informed consent form (Parent Information Sheet, PIS) signed by one of parents/adoptive parents (for participants aged 3-17 years old inclusive).
Negative result of SARS-CoV-2 antigen rapid test at screening.
Negative pregnancy test result in fertile females of reproductive age. For females not reached puberty, and for girls/women unable to childbirth (with past infertility, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, menopause for more than 2 years), the pregnancy test shall not be performed.
For participants of 14-55 years old inclusive with preserved reproductive function, the consent to use of reliable methods of contraception (abstinence, condoms in combination with spermicide and/or hormonal contraception) during the study.
For participants aged 3-13 years old inclusive and females incapable of childbearing, the consent to use reliable methods of contraception is not required.
The consent of a participant and/or a parent/an adoptive parent of a participant to cooperate in good faith with the investigator and the center staff, come to appointed visits, fill out the observation diary and comply with the requirements of the Protocol.

Who cannot join

Hypersensitivity to any component of the test/reference drug.
Evident severe systemic reactions to any vaccines in anamnesis.
Impossibility of intramuscular injections.
Changes in the skin (pigmentation, tattoo, scars etc.) at the planned injection site of the test/reference drug (the deltoid muscle area).
Acute infectious and non-infectious diseases, exacerbation of chronic diseases at screening or less than 14 days before screening.
Body temperature measured in the armpit ≥ 37.0°C at Visits 0 and 1.

Show all 24Show fewer

The history of chronic diseases that are significant in the opinion of the investigator (for example, malignant neoplasms, blood diseases, autoimmune diseases, immunodeficiencies, etc.).
The history of meningococcal infection.
Contact with a person with the confirmed infection caused by N. meningitidis less than 2 months before screening.
The history of convulsive syndrome or the advanced neurological disease.
The history of Guillain-Barré syndrome.
The history of mental diseases.
Drug administration:
the history of meningococcal mono- or polyvalent vaccine, influenza vaccine within 14 days before screening, other vaccines within 30 days before screening;
immunostimulants less than 30 days before screening;
the immunosuppressive therapy, including systemic corticosteroids, prescribed for more than 5 days, or in the daily dose of more than 1 mg/kg/day of prednisolone or its equivalent - less than 30 days before screening;
antipyretics, analgesics - for less than 24 hours before Visits 0 and 1;
systemic antibacterial drugs-- for less than 72 hours before Visits 0 and 1;
anticoagulants - for less than 3 weeks before Visits 0 and 1;
immunoglobulins, blood or plasma products - for less than 3 months before Visits 0 and 1.
Planning the administration of vaccines with the exception of the test/reference drug during the clinical study.
Surgical interventions performed less than 3 months before screening.
Participation in another clinical study less than 30 days before screening.
Other conditions that, in the opinion of the investigator, interfere to the enrollment.

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kirill Klimkin contact

+7(495) 730-75-45

KlimkinKA@petrovax.ru

City, postcode or hospital

Sites recruiting now only

17 sites in 1 country

Russia17 sites, 10 recruiting

Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Health of the Russian Federation
Kirov
Completed
Federal Budgetary Scientific Institution "Central Research Institute of Epidemiology" of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing
Moscow
Aleksandr Gorelov, Doctor of Medical Sciences, +7(495)6721158, agorelov_05@mail.ru
Recruiting
Federal State Budgetary Scientific Institution "I.I. Mechnikov Research Institute of Vaccines and Serums"
Moscow
Completed
Federal State Budgetary Scientific Institution "Russian Scientific Center of Surgery named after Academician B.V. Petrovsky"
Moscow
Leyla Namazova-Baranova, Doctor of Medical Sciences, +7(495) 1320203, leyla.s.namazova@gmail.com
Recruiting
State Budgetary Institution of Healthcare of the City of Moscow "Morozovskaya Children's City Clinical Hospital of the Moscow City Healthcare Department"
Moscow
Alexey Rtishchev, Candidate of Medical Sciences, +7(495)9598801, rtishchev@inbox.ru
Recruiting
Federal State Budgetary Educational Institution of Higher Education "Perm State Medical University named after Academician E.A. Wagner" of the Ministry of Health of the Russian Federation
Perm
Completed
State Budgetary Healthcare Institution of Perm Krai "City Children's Clinical Polyclinic No. 5"
Perm
Olga Perminova, Candidate of Medical Sciences, +7(342)2280925, perminova20062006@yandex.ru
Recruiting
Federal State Budgetary Institution "A. A. Smorodintsev Research Institute of Influenza" of the Ministry of Health of the Russian Federation
Saint Petersburg
Completed
Federal State Budgetary Institution "Children's Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency"
Saint Petersburg
Completed
Limited Liability Company "Energy of Health"
Saint Petersburg
Svetlana Lazareva, +7(812)3352958, alexlaz58@rambler.ru
Recruiting
Limited Liability Company "PiterClinic"
Saint Petersburg
Tatiana Pak, Candidate of Medical Sciences, +7 (812) 9818284, pte@list.ru
Recruiting
Saint Petersburg State Budgetary Healthcare Institution "Children's City Polyclinic No. 44"
Saint Petersburg
Olga Trusova, Doctor of Medical Sciences, +7(812)4174002, o-tru@mail.ru
Recruiting
Federal State Budgetary Educational Institution of Higher Education "National Research Mordovian State University named after N.P. Ogarev"
Saransk
Svetlana Garina, Candidate of Medical Sciences, +7(8342)353002, astra-svet@rambler.ru
Recruiting
Limited Liability Company "DNA Research Center"
Saratov
Lubov Aleshina, Candidate of Medical Sciences, +7(8452)756292, lubov-sk@mail.ru
Recruiting
Limited Liability Company "DNA Research Center"
Saratov
Completed
Federal State Budgetary Educational Institution of Higher Education "Smolensk State Medical University" of the Ministry of Health of the Russian Federation
Smolensk
Elena Kozlova, Candidate of Medical Sciences, +7(4812)381412, keu83smol@yandex.ru
Recruiting
State Budgetary Healthcare Institution of the Sverdlovsk Region "Central City Hospital No. 7, Yekaterinburg"
Yekaterinburg
Completed

Other trials in Russia

About this study

Official title: Simple Blinded Multicenter Randomized Comparative Study to Assess Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE

Assessment of immunogenicity, reactogenicity and safety of GNG-DE in comparison with the reference drug

Conditions: Infections, Meningococcal
Being tested: polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y
Medical subject headings: Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, YDrug
Group 1 (n = 40) will receive GNG-DE at a dose of 0.5 mL intramuscularly into the deltoid site.
Group 2 (n = 40) will receive Menactra® at a dose of 0.5 mL intramuscularly into the deltoid site.

Study groups in NCT06834100
Study group	Role	What they receive
Stage I	Experimental	At this stage, adult volunteers aged 18-55 years old (inclusive) will be enrolled in the study. After screening procedures, 80 volunteers who meet the eligibility criteria and do not meet any non-eligibility criteria will be randomized into 2 groups in a 1: 1 ratio Receives: Drug: polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y
Stage II	Experimental	Stage II will begin after receiving the positive conclusion of the IDMC on the basis of the consideration of stage I data. At this stage, adolescents aged 11-17 years old (inclusive) will be included in the study. After screening procedures, 80 adolescents who meet the eligibility criteria and do not meet any non-eligibility criteria will be randomized into 2 groups in a 1:1 ratio Receives: Drug: polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y
Stage III	Experimental	Stage III will begin after receiving the positive conclusion of the IDMC on the basis of the consideration of stage II data. At this stage, children aged 3-10 years old (inclusive) will be included in the study. After screening procedures, 80 children who meet the eligibility criteria and do not meet any non-eligibility criteria will be randomized into 2 groups in a 1:1 ratiowill receive Menactra® at a dose of 0.5 mL intramuscularly into the deltoid site. Receives: Drug: polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary immunogenicity parameter
Proportion (frequency) of subjects with seroconversion to meningococcal serogroups A, C, Y and W135 Seroconversion is defined as (for each serogroup it is determined separately)
Measured: Day 29 ± 1

Secondary outcomes (2)

Secondary immunogenicity parameters
The proportion (frequency) of vaccinated subjects with seroprotection
Measured: Day 29 ± 1
Secondary immunogenicity parameters
Geometric mean titers of SBA to antigens of meningococcal serogroups A, C, Y and W135
Measured: Day 29 ± 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Feb 202531 Dec 2025

First posted19 Feb 2025
Study start12 Feb 2025
Primary completion31 Dec 2025 (estimated)
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for InfectionsStudies 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
Model description: In the study, 240 subjects aged 3-55 years (inclusive) meeting the eligibility criteria and not meeting any non-eligibility criteria will be randomized, of which there are 80 adult volunteers aged 18-55 years inclusive, 80 adolescents aged 11-17 years inclusive, 80 children aged 3-10 years inclusive. Taking into account the possible withdrawal at the screening stage, the maximum number of subjects included in the study will be no more than 260.
Masking: Single blind
Who is masked: Participant
Enrolment: 240 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06834100
Sponsor's protocol ID: GNG-DE-III-24
Status last verified: Nov 2025
First submitted: 13 Feb 2025
Last updated: 29 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Kirill Klimkin

+7(495) 730-75-45

KlimkinKA@petrovax.ru

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Simple Blinded Multicenter Randomized Comparative Study to Assess Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE
ClinicalTrials.gov ID: NCT06834100
Acronym / sponsor ID: GNG-DE-III-24
Conditions: Infections, Meningococcal
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 240 participants (estimated)
Lead sponsor: NPO PetrovaxIndustry (pharma, biotech, devices)
Study start: 12 Feb 2025 (actual)
Primary completion: 31 Dec 2025 (estimated)
Study completion: 31 Dec 2025 (estimated)
First posted: 19 Feb 2025 (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.

Assessment of immunogenicity, reactogenicity and safety of GNG-DE in comparison with the reference drug

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3
Model description: In the study, 240 subjects aged 3-55 years (inclusive) meeting the eligibility criteria and not meeting any non-eligibility criteria will be randomized, of which there are 80 adult volunteers aged 18-55 years inclusive, 80 adolescents aged 11-17 years inclusive, 80 children aged 3-10 years inclusive. Taking into account the possible withdrawal at the screening stage, the maximum number of subjects included in the study will be no more than 260.

Arm	Type	Receives
Stage I	Experimental	Drug: polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, YAt this stage, adult volunteers aged 18-55 years old (inclusive) will be enrolled in the study. After screening procedures, 80 volunteers who meet the eligibility criteria and do not meet any non-eligibility criteria will be randomized into 2 groups in a 1: 1 ratio
Stage II	Experimental	Drug: polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, YStage II will begin after receiving the positive conclusion of the IDMC on the basis of the consideration of stage I data. At this stage, adolescents aged 11-17 years old (inclusive) will be included in the study. After screening procedures, 80 adolescents who meet the eligibility criteria and do not meet any non-eligibility criteria will be randomized into 2 groups in a 1:1 ratio
Stage III	Experimental	Drug: polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, YStage III will begin after receiving the positive conclusion of the IDMC on the basis of the consideration of stage II data. At this stage, children aged 3-10 years old (inclusive) will be included in the study. After screening procedures, 80 children who meet the eligibility criteria and do not meet any non-eligibility criteria will be randomized into 2 groups in a 1:1 ratiowill receive Menactra® at a dose of 0.5 mL intramuscularly into the deltoid site.

Who may qualify

Ages: 3 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

Male and female subjects aged 3-55 years old inclusive at the time of screening beginning.
Availability of a signed Volunteer Informed Consent Form (Volunteer Information Sheet, VIS) (for participants aged 7-55 years inclusive) and/or the parent/adoptive parent informed consent form (Parent Information Sheet, PIS) signed by one of parents/adoptive parents (for participants aged 3-17 years old inclusive).
Negative result of SARS-CoV-2 antigen rapid test at screening.
Negative pregnancy test result in fertile females of reproductive age. For females not reached puberty, and for girls/women unable to childbirth (with past infertility, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, menopause for more than 2 years), the pregnancy test shall not be performed.
For participants of 14-55 years old inclusive with preserved reproductive function, the consent to use of reliable methods of contraception (abstinence, condoms in combination with spermicide and/or hormonal contraception) during the study.

Key exclusion criteria (24 listed)

Hypersensitivity to any component of the test/reference drug.
Evident severe systemic reactions to any vaccines in anamnesis.
Impossibility of intramuscular injections.
Changes in the skin (pigmentation, tattoo, scars etc.) at the planned injection site of the test/reference drug (the deltoid muscle area).
Acute infectious and non-infectious diseases, exacerbation of chronic diseases at screening or less than 14 days before screening.

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
polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, YGroup 1 (n = 40) will receive GNG-DE at a dose of 0.5 mL intramuscularly into the deltoid site. Group 2 (n = 40) will receive Menactra® at a dose of 0.5 mL intramuscularly into the deltoid site.	Drug	Stage I, Stage II, Stage III

Primary outcome

Primary immunogenicity parameter
Time frame: Day 29 ± 1
Proportion (frequency) of subjects with seroconversion to meningococcal serogroups A, C, Y and W135 Seroconversion is defined as (for each serogroup it is determined separately)

2 secondary outcomes

Secondary immunogenicity parameters
Time frame: Day 29 ± 1
Secondary immunogenicity parameters
Time frame: Day 29 ± 1

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.

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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.

Kirill Klimkin contact

+7(495) 730-75-45

KlimkinKA@petrovax.ru

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kirill Klimkin (+7(495) 730-75-45, KlimkinKA@petrovax.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary immunogenicity parameter (time frame: Day 29 ± 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06834100.

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 29 Dec 2025.