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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-month-old experimental group | Experimental | Vaccination of 4 doses of experimental vaccine(0,2,4,1 booster dose) |
|
| 2-month-old control group | Active Comparator | Vaccination of 4 doses of control vaccine(0,2,4,1 booster dose) |
|
| 3-month-old group | Experimental | Vaccination of 4 doses of experimental vaccine(0,1,2,1 booster dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-valent pneumococcal conjugate vaccine (multivalent conjugate) | Biological | the 2-month-old experimental group and the 3-month-old group received the experimental vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| seroprotection rate of 13 vaccine serotype-specific pneumococcal IgG antibodies | Immunogenicity | 30 days after primary immunization |
| 13 vaccine serotype-specific pneumococcal IgG antibodies GMC | Immunogenicity | 30 days after primary immunization |
| incidence of adverse events (AE) | Safety | 30 minutes/0~7 days/0~30 days after each dose of vaccination |
| incidence of all serious adverse events (SAEs) | Safety | from the first dose to 6 months after primary immunization |
| incidence of all serious adverse events (SAEs) | Safety | from the first dose of vaccination to 12 months after the booster immunization |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of subjects with 13 vaccine serotype-specific pneumococcal IgG antibody concentrations ≥1.0 μg/ml | Primary stage | 30 days after primary immunization |
| the positivity rate of pneumococcal OPA antibodies for 13 vaccine serotypes |
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Inclusion Criteria:
Primary immunization phase:
Booster immunization phase:
Exclusion Criteria:
Primary immunization phase:
Booster immunization phase:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yizhou District Disease Prevention Control Center | Hechi | Guangxi | 547000 | China | ||
| Zhongshan County Center for Disease Control and Prevention |
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| Prevenar 13 | Biological | the 2-month-old control group received the active control vaccine |
|
Primary stage
| 30 days after primary immunization |
| the GMT of pneumococcal OPA antibodies for 13 vaccine serotypes | Primary stage | 30 days after primary immunization |
| the seroconversion rate of pneumococcal OPA antibodies for 13 vaccine serotypes | Primary stage | 30 days after primary immunization |
| seroprotection rate of 13 vaccine serotype-specific pneumococcal IgG antibodies | Booster stage | 30 days after booster immunization |
| percentage of subjects with 13 vaccine serotype-specific pneumococcal IgG antibody concentrations ≥ 1.0 μg/mL | Booster stage | 30 days after booster immunization |
| GMC of 13 vaccine serotype-specific pneumococcal IgG antibodies | Booster stage | 30 days after booster immunization |
| the positivity rate of pneumococcal OPA antibodies for 13 vaccine serotypes | Booster stage | 30 days after booster immunization |
| the GMT of pneumococcal OPA antibodies for 13 vaccine serotypes | Booster stage | 30 days after booster immunization |
| Hezhou |
| Guangxi |
| 542800 |
| China |
| Luzhai County Disease Prevention Control Center | Liuzhou | Guangxi | 545000 | China |
| Binyang County Center for Disease Control and Prevention | Nanning | Guangxi | 530000 | China |
| Wuming District Center for Disease Control and Prevention | Nanning | Guangxi | 530000 | China |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
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