The scientific name of meningococcus is Neisseria meningitidis (Nm), the causative agent of epidemic meningococcal meningitis (rheumatoid encephalitis), which colonizes the mucous membranes of the human nasopharynx or causes local infection and can cross the mucosal barrier to cause invasive bacteremia or epidemic meningococcal meningitis, meningococcus can often cause serious disease epidemics worldwide, the main clinical features of its infection are fever, rash and meningitis, the most common clinical manifestation is acute bacterial meningitis.
The preventive measures for influenza are based on strengthening personal protection, vaccination, strengthening surveillance, early detection of patients, and active isolation and treatment. The immune response to meningococcal polysaccharide vaccine is weak in infants under 2 years of age, and only a transient immune response is produced. Numerous experiments have shown that the immunogenicity of polysaccharides is enhanced by binding to protein carriers, and a significant booster effect is produced. Meningococcal polysaccharide conjugate vaccine induces a good immune response in infants and children under 2 years of age and produces immune memory, which enhances the immune effect of the vaccine and can eliminate the carrier state of infected patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,000
Shanyang County Center for Disease Prevention and Control
Shanyang, Shaanxi, China
Geometric mean titers (GMT) of meningococcal antibodies to groups A, C, Y and W135 in all subjects 30 days after immunization
Time frame: 30 days after immunization
Positive conversion rates of meningococcal antibodies to groups A, C, Y and W135 in all subjects 30 days after immunization
Time frame: 30 days after immunization
Incidence of adverse reactions within 30 minutes after immunization in all subjects
Time frame: Within 30 minutes after immunization
Incidence of adverse reactions/events within 7 days of immunization for all subjects
Time frame: Within 7 days after immunization
Incidence of adverse reactions/events within 30 days of exemption for all subjects
Time frame: Within 30 days of exemption
Meningococcal positivity for groups A, C, Y, and W135 for all subjects 30 days after immunization
Time frame: 30 days after immunization
Geometric mean growth multiplier (GMI) for all subjects 30 days after immunization
Time frame: 30 days after immunization
Antibody titers ≥1:128 ratio for all subjects 30 days after immunization
Time frame: 30 days after immunization
Meningococcal antibody positivity for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects
Time frame: 90 and 180 days of exemption
GMT for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects
Time frame: 90 and 180 days of exemption
GMI for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects
Time frame: 90 and 180 days of exemption
Antibody titers ≥1:128 ratio for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects
Time frame: 90 and 180 days of exemption
Incidence of serious adverse events (SAEs) within 180 days of exemption in all subjects
Time frame: Within 180 days of exemption
All subjects were stratified into susceptible (<1:8) and non-susceptible (≥1:8) populations according to the 1:8 pre-immune antibody titer threshold
Time frame: 30 days after immunization
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