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

Официальное название

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

Обзор

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

Вмешательства

• Препарат polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y
  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.

Первичные конечные точки

• Primary immunogenicity parameter [Срок оценки: Day 29 ± 1]

Вторичные конечные точки (2)

• Secondary immunogenicity parameters [Срок оценки: Day 29 ± 1]
• Secondary immunogenicity parameters [Срок оценки: Day 29 ± 1]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Россия · 17 центров

• Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical U — Kirov
• Federal Budgetary Scientific Institution "Central Research Institute of Epidemiology" of t — Moscow
• Federal State Budgetary Scientific Institution "I.I. Mechnikov Research Institute of Vacci — Moscow
• Federal State Budgetary Scientific Institution "Russian Scientific Center of Surgery named — Moscow
• State Budgetary Institution of Healthcare of the City of Moscow "Morozovskaya Children's C — Moscow
• Federal State Budgetary Educational Institution of Higher Education "Perm State Medical Un — Perm
• State Budgetary Healthcare Institution of Perm Krai "City Children's Clinical Polyclinic N — Perm
• Federal State Budgetary Institution "A. A. Smorodintsev Research Institute of Influenza" o — Saint Petersburg
• … и ещё 9 центров

Идентификаторы

NCT: NCT06834100 · GNG-DE-III-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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