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Tests treatment safety and results for Infections
Official title Assessment of Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE in Comparison With the Reference Drug
ClinicalTrials.gov ID: NCT06834100
What this study is testing
What is polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y?
polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Assessment of immunogenicity, reactogenicity and safety of GNG-DE in comparison with the reference drug
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Male and female people 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...
- 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...
- For participants of 14-55 years old inclusive with preserved reproductive function, the consent to use of reliable methods of contraception...
You likely can't join if
- 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.
See the full eligibility criteria
- Male and female people 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...
- 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...
- 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kirov, Russia
- Moscow, Russia
- Perm, Russia
- Saint Petersburg, Russia
- Saransk, Russia
- Saratov, Russia
- Smolensk, Russia
- Yekaterinburg, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kirov, Russia; Moscow, Russia; Perm, Russia; Saint Petersburg, Russia; Saransk, Russia; Saratov, Russia and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.