Assessment of Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE in Comparison With the Reference Drug
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3-55
SponsorNPO Petrovax
About this trial
Assessment of immunogenicity, reactogenicity and safety of GNG-DE in comparison with the reference drug
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y
Treatment groups
240 Participants
are divided into 3 treatment groupsLocations
17Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Health of the Russian Federation Kirov Russia
Federal Budgetary Scientific Institution "Central Research Institute of Epidemiology" of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing Moscow Russia
Federal State Budgetary Scientific Institution "I.I. Mechnikov Research Institute of Vaccines and Serums" Moscow Russia
Federal State Budgetary Scientific Institution "Russian Scientific Center of Surgery named after Academician B.V. Petrovsky" Moscow Russia
Sponsors and collaborators
NPO Petrovax
Lead sponsor
Source ClinicalTrials.gov