RecruitingPhase 3

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

Russia240 participantsStarted 2025-02-12

Plain-language summary

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

Age range3 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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.

✕. 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.

Primary immunogenicity parameter

Timeframe: Day 29 ± 1

NCT IDNCT06834100

SponsorNPO Petrovax

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-31

Kirill Klimkin

Who can participate

Age range3 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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.

✕. 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.