This study is a phase III clinical trial to evaluate the immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine (multivalent conjugate) in infants aged 2 months (at least 6 weeks) and 3 months. The main objectives of the study include: 1. To evaluate the immunogenicity of the trial vaccine in infants aged 2 months (at least 6 weeks) following the corresponding immunization schedule compared to the control vaccine; 2. To evaluate the immunogenicity of the trial vaccine in infants aged 3 months following the corresponding immunization schedule compared to the 2-month group; 3. To evaluate the safety of the trial vaccine in infants aged 2 months (at least 6 weeks) and 3 months following the corresponding immunization schedule.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,800
the 2-month-old experimental group and the 3-month-old group received the experimental vaccine
the 2-month-old control group received the active control vaccine
Yizhou District Disease Prevention Control Center
Hechi, Guangxi, China
Zhongshan County Center for Disease Control and Prevention
Hezhou, Guangxi, China
Luzhai County Disease Prevention Control Center
Liuzhou, Guangxi, China
Binyang County Center for Disease Control and Prevention
Nanning, Guangxi, China
Wuming District Center for Disease Control and Prevention
Nanning, Guangxi, China
seroprotection rate of 13 vaccine serotype-specific pneumococcal IgG antibodies
Immunogenicity
Time frame: 30 days after primary immunization
13 vaccine serotype-specific pneumococcal IgG antibodies GMC
Immunogenicity
Time frame: 30 days after primary immunization
incidence of adverse events (AE)
Safety
Time frame: 30 minutes/0~7 days/0~30 days after each dose of vaccination
incidence of all serious adverse events (SAEs)
Safety
Time frame: from the first dose to 6 months after primary immunization
incidence of all serious adverse events (SAEs)
Safety
Time frame: from the first dose of vaccination to 12 months after the booster immunization
percentage of subjects with 13 vaccine serotype-specific pneumococcal IgG antibody concentrations ≥1.0 μg/ml
Primary stage
Time frame: 30 days after primary immunization
the positivity rate of pneumococcal OPA antibodies for 13 vaccine serotypes
Primary stage
Time frame: 30 days after primary immunization
the GMT of pneumococcal OPA antibodies for 13 vaccine serotypes
Primary stage
Time frame: 30 days after primary immunization
the seroconversion rate of pneumococcal OPA antibodies for 13 vaccine serotypes
Primary stage
Time frame: 30 days after primary immunization
seroprotection rate of 13 vaccine serotype-specific pneumococcal IgG antibodies
Booster stage
Time frame: 30 days after booster immunization
percentage of subjects with 13 vaccine serotype-specific pneumococcal IgG antibody concentrations ≥ 1.0 μg/mL
Booster stage
Time frame: 30 days after booster immunization
GMC of 13 vaccine serotype-specific pneumococcal IgG antibodies
Booster stage
Time frame: 30 days after booster immunization
the positivity rate of pneumococcal OPA antibodies for 13 vaccine serotypes
Booster stage
Time frame: 30 days after booster immunization
the GMT of pneumococcal OPA antibodies for 13 vaccine serotypes
Booster stage
Time frame: 30 days after booster immunization
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