Assessment of immunogenicity, reactogenicity and safety of GNG-DE in comparison with the reference drug
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
240
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.
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 ± 1
Secondary immunogenicity parameters
The proportion (frequency) of vaccinated subjects with seroprotection
Time frame: Day 29 ± 1
Secondary immunogenicity parameters
Geometric mean titers of SBA to antigens of meningococcal serogroups A, C, Y and W135
Time frame: Day 29 ± 1
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