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

NPO Petrovax

Status and phase: Enrolling; Phase 3

Conditions: Meningococcal; Infections

Treatments: Drug: polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y

Study type: Interventional

Funder types: Industry

Identifiers

NCT06834100

GNG-DE-III-24

Details and patient eligibility

About

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

Enrollment: 240 estimated patients

Sex: All

Ages: 3 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male and female subjects aged 3-55 years old inclusive at the time of screening beginning.

2. 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).

3. Negative result of SARS-CoV-2 antigen rapid test at screening.

4. 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.

5. 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.

6. 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.

Exclusion criteria

1. Hypersensitivity to any component of the test/reference drug.

2. Evident severe systemic reactions to any vaccines in anamnesis.

3. Impossibility of intramuscular injections.

4. Changes in the skin (pigmentation, tattoo, scars etc.) at the planned injection site of the test/reference drug (the deltoid muscle area).

5. Acute infectious and non-infectious diseases, exacerbation of chronic diseases at screening or less than 14 days before screening.

6. Body temperature measured in the armpit ≥ 37.0°C at Visits 0 and 1.

7. The history of chronic diseases that are significant in the opinion of the investigator (for example, malignant neoplasms, blood diseases, autoimmune diseases, immunodeficiencies, etc.).

8. The history of meningococcal infection.

9. Contact with a person with the confirmed infection caused by N. meningitidis less than 2 months before screening.

10. The history of convulsive syndrome or the advanced neurological disease.

11. The history of Guillain-Barré syndrome.

12. The history of mental diseases.

13. 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.

14. Planning the administration of vaccines with the exception of the test/reference drug during the clinical study.

15. Surgical interventions performed less than 3 months before screening.

16. Participation in another clinical study less than 30 days before screening.

17. Other conditions that, in the opinion of the investigator, interfere to the enrollment.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

240 participants in 3 patient groups

Stage I

Experimental group

Description:

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

Treatment:

Drug: polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y

Stage II

Experimental group

Description:

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

Treatment:

Drug: polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y

Stage III

Experimental group

Description:

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.

Treatment:

Drug: polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y