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This clinical study aims to evaluate the mutual influence of combined administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus, Pertussis Vaccine in the target population
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P+DTP group | Experimental | 370 infants aged 3 months were enrolled in this group. |
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| P-DTP group | Experimental | 370 infants aged 3 months were enrolled in this group. |
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| DTP group | Active Comparator | 370 infants aged 3 months were enrolled in this group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) | Biological | Administer 0.5ml of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) separately at different locations upon enrollment. Both vaccine were immunized according to the 0, 1, and 2 month procedures (calculated as 30 days per month). |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody positive conversion rate | The positive conversion rates of diphtheria antibody (anti-D), tetanus antibody (anti-T), pertussis toxin antibody (anti-PT), and pertussis filamentous hemagglutinin antibody (anti-FHA) in P+DTP, P-DTP, and DTP groups,respectively. | 30 days after full vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| AEs within 0-30 minutes after vaccination | The occurrence of all adverse events within 0-30 minutes after each dose of vaccination | 0-30 minutes after vaccination |
| Solicited AEs within 0-7 days after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lin Du, Doctor | Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Provincial Center for Disease Control and Prevention | Shijiazhuang | Hebei | 050021 | China |
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| 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) | Biological | Vaccination with 15-Valent Pneumococcal Conjugate Vaccine with a 7-day interval (+15 day window period) followed by vaccination with Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed). Both vaccine were immunized according to the 0, 1, and 2 month procedures (calculated as 30 days per month). |
|
| Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) | Biological | Only administer the Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) and according to the 0, 1, and 2 month procedures (calculated as 30 days per month). |
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The occurrence of all solicited adverse events within 0-7 days after each dose of vaccination
| 0-7 days after vaccination |
| Unsolicited AEs within 0-30 days after vaccination | The occurrence of all unsolicited adverse events within 0-30 days after each dose of vaccination. | 0-30 days after vaccination |
| SAE within 0-6 months after primary immunization | The occurrence of all serious adverse events within 0-6 months after primary immunization. | 0-6 months after primary immunization |
| Positive rate of IgG antibodies | Positive rate of susceptible individuals with 15 serotype specific pneumococcal IgG antibodies (percentage of subjects with antibody concentration ≥ 0.35 μ g/ml) | 30 days after full vaccination |
| GMC of IgG antibody | GMC of IgG antibody against 15 serotype specific pneumococcal. | 30 days after full vaccination |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| D004165 | Diphtheria |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D003015 | Clostridium Infections |
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| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| D004602 | Elements |
| D017778 | Vaccines, Combined |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D007287 | Inorganic Chemicals |
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