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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y
DrugGroup 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.
Treatment groups
240 Participants
are divided into 3 treatment groupsGroup A: Stage IExperimental treatment 1 intervention
Group B: Stage IIExperimental treatment 1 intervention
Group C: Stage IIIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary immunogenicity parameter
Proportion (frequency) of subjects with seroconversion to meningococcal serogroups A, C, Y and W135 Seroconversion is defined as (for each serogroup it is determined separately)
Time frame
Day 29 ± 1Secondary outcomes
1
Secondary immunogenicity parameters
The proportion (frequency) of vaccinated subjects with seroprotection
Time frame
Day 29 ± 12
Secondary immunogenicity parameters
Geometric mean titers of SBA to antigens of meningococcal serogroups A, C, Y and W135
Time frame
Day 29 ± 1Other outcomes
1
SAFETY ASSESSMENT
Criteria for assessing reactogenicity : * The proportion (frequency) of vaccinated subjects with expected local reactions (pain, redness, swelling) of any severity. * The proportion (frequency) of vaccinated subjects with expected systemic reactions (fever (according to measurement of body temperature in the armpit), gastrointestinal symptoms (abdominal pain, nausea, vomiting or diarrhea), headache, drowsiness, irritability, loss of appetite, arthralgia) of any severity. * The proportion (frequency) of vaccinated subjects with severe local reactions (pain, redness, swelling). * The proportion (frequency) of vaccinated subjects with severe systemic reactions (fever (according to measurement of body temperature in the armpit), gastrointestinal symptoms (abdominal pain, nausea, vomiting or diarrhea), headache, drowsiness, irritability, loss of appetite, arthralgia).
Time frame
1-7 days after vaccination, including the day of vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov