The purpose of this study was to explore the safety and immunogenicity of the experimental vaccine compared with the control vaccines. It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be randomly assigned to the trial in a 1:1 ratio to study group or control group. The 3-5 month-old group will have three doses vaccination at 0, 1 and 2 month, and a booster dose at 12 months of age; the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination; the 2-15 year-old group will have one dose vaccination.
The purpose of this study was to evaluate the safety and immunogenicity of the experimental vaccine(ACYW135 Meningococcal Polysaccharide Conjugate Vaccine) compared with the control vaccines(ACYW135 Meningococcal Polysaccharide Conjugate Vaccine and ACYW135 Meningococcal Polysaccharide Vaccine). It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be randomly assigned to the trial in a 1:1 ratio to study group or control group. The 3-5 month-old group will have three doses vaccination at 0, 1 and 2 month, and a booster dose at 12 months of age; the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination(at month 0, 1 or at month 0, 3); the 2-15 year-old group will have one dose vaccination. The immunogenicity and immune persistence will be evaluated by rabbit complement serum bactericidal assay.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,200
ACYW135 Meningococcal Polysaccharide Conjugate Vaccine was produced by meningococcal polysaccharide from group A, C, Y, W135 and conjugated protein CRM197.
ACYW135 Meningococcal Polysaccharide Vaccine was produced by meningococcal polysaccharide from group A, C, Y, W135.
Yunnan Center For Disease Control and Prevention
Kunming, Yunnan, China
Immunogenicity 1
To evaluate the positive conversion rate and geometric mean titer (GMT) of meningococcal serum bactericidal activity (rSBA) antibodies for meningococcal groups A, C, Y, and W135 at 30 days in 3\~5 months old participants after primary vaccination
Time frame: 30 days after primary vaccination
Immunogenicity 2
To evaluate the positive conversion rate and geometric mean titer (GMT) of meningococcal serum bactericidal activity (rSBA) antibodies for meningococcal groups A, C, Y, and W135 at 30 days in 6\~23 months old participants after two doses vaccination
Time frame: 30 days after two doses vaccination
Immunogenicity 3
To evaluate the positive conversion rate and geometric mean titer (GMT) of meningococcal serum bactericidal activity (rSBA) antibodies for meningococcal groups A, C, Y, and W135 at 30 days in 2\~15 years old participants after one dose vaccination
Time frame: 30 days after one dose vaccination
Safety 1
The incidence of adverse events (AEs)/vaccination-related AEs on days 0 to 30 after each dose of immunization for subjects in each age group
Time frame: 30 days after each dose vaccination
Immunogenicity 4
To evaluate the positive rate of serum bactericidal activity (rSBA) antibodies against meningococcal groups A, C, Y and W135 (ratio of antibody titers ≥1:8), ratio of antibody titer ≥1:128, geometric mean growth factor (GMFI) in 3\~5 months old participants after primary vaccination
Time frame: 30 days after booster vaccination
Immunogenicity 5
To evaluate the serum bactericidal activity (rSBA) antibody GMT, positivity rate and rate of antibody titer ≥1:128 subjects in 3\~5 months old participants before booster vaccination
Time frame: Before booster vaccination
Immunogenicity 6
To evaluate the serum bactericidal activity (rSBA) antibody positive conversion rate, GMT, GMFI, positivity rate, and rate of antibody titer≥ 1:128 ratio in 3\~5 months old participants after booster vaccination
Time frame: 30 days after booster vaccination
Immunogenicity 7
To evaluate the positive rate of serum bactericidal activity (rSBA) antibodies against meningococcal groups A, C, Y and W135 (ratio of antibody titers ≥1:8), ratio of antibody titer ≥1:128, geometric mean growth factor (GMFI) in 6\~23 months old participants after two doses vaccination
Time frame: 30 days after booster vaccination
Immunogenicity 8
To evaluate the positive rate of serum bactericidal activity (rSBA) antibodies against meningococcal groups A, C, Y and W135 (ratio of antibody titers ≥1:8) and ratio of antibody titer ≥1:128 in 6\~23 months old participants after vaccination
Time frame: 30 days after vaccination
Immune persistence 1
To evaluate the serum bactericidal activity (rSBA) antibody positivity rate, rate of antibody titer ≥1:128 and GMT in 3\~5 months old participants after booster vaccination
Time frame: 6 months after booster vaccination
Immune persistence 2
To evaluate the serum bactericidal activity (rSBA) antibody positivity rate, rate of antibody titer ≥1:128 and GMT in 6\~23 months old participants after two doses vaccination
Time frame: 6 months, 12 months
Safety 2
AEs/vaccination-related AEs are divided into doses, severity, vaccination site and non-vaccination site, and system organs (SOC) classification and incidence of each preferred term (PT) symptom after each dose vaccination
Time frame: 30 days after each dose vaccination
Safety 3
The occurrence of serious adverse events (SAE) in each group of subjects aged 3 to 5 months from the first dose vaccination to 6 months after primary vaccination and within 30 days after booster vaccination
Time frame: 6 months after primary vaccination and 30 days after booster vaccination
Safety 4
The occurrence of serious adverse events (SAE) in each group of subjects aged 2\~15 years and 6\~23 months from the first dose vaccination to 6 months after all doses vaccination
Time frame: 6 months after all doses vaccination
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