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The combined pertussis, diphtheria and tetanus vaccine, the first vaccine to be included in the Expanded Programme of Immunization(EPI) of World Health Organization(WHO), has played an important role in the prevention and control of these three infectious diseases. The (diphtheria,tetanus and acellular pertussis combined vaccine,DTaP) vaccine was successfully developed in China in 1993, and its safety and serological effects were confirmed by the observation of human safety, with mild vaccination reactions and good immunization effects.The (Diphtheria-tetanus-component acellular pertussis vaccine, DTcP) vaccine is suitable for immunization against pertussis, diphtheria and tetanus infections in people between 2 and 24 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental vaccine group A,3 months old | Experimental | 4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 1,2,15~21 |
|
| Control vaccine group B,3 months old | Active Comparator | 4 doses of DTaP vaccine (0.5 ml) on Day 0 and Month 1,2,15~21 |
|
| Control vaccine group C,3 months old | Active Comparator | 4 doses of DTaP-IPV-Hib vaccine (0.5 ml) on Day 0 and Month 1,2,15~21 |
|
| Experimental vaccine group D,2 months old | Experimental | 4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 1,2,16~22 |
|
| Control vaccine group E,2 months old | Active Comparator | 4 doses of DTaP-IPV-Hib vaccine (0.5 ml) on Day 0 and Month 1,2,16~22 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP) | Biological | Three doses of basic immunization were completed at 3, 4 and 5 months of age, and one dose of booster immunization was completed at 18 to 24 months of age. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum anti-Pertussis Toxoid(PT), Filamentous hemagglutmin(FHA), Pertactin(PRN), DT(Diphtheria Toxoid), TT(Tetanus Toxoid) antibody positive conversion rate,GMC 30 days after completion of basal immunization in subjects in the 3-month-old group | 30 days after completion of basal immunization | |
| Serum anti-PT, FHA, PRN, DT, TT antibody positive conversion rate, Geometric Mean Concentration(GMC) 30 days after completion of basal immunization in subjects in the 2-month-old group | 30 days after completion of basal immunization | |
| Incidence of adverse reactions within 0-30 days after each dose of vaccination in subjects in the 3-month-old group | Within 0-30 days after each dose of vaccination | |
| Incidence of adverse reactions within 0-30 days after each dose of vaccination in subjects in the 2-month-old group | Within 0-30 days after each dose of vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changge Center for Disease Control and Prevention | Xuchang | Henan | 461500 | China |
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| Experimental vaccine group F,2 months old | Experimental | 4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 2,4,16~22 |
|
| Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine,DTaP | Biological | Three doses of basic immunization were completed at 3, 4 and 5 months of age, and one dose of booster immunization was completed at 18 to 24 months of age. |
|
| Diphtheria,tetanus,pertussis(acellular,component),Inactivated polio vaccine(adsorbed)and Haemophilus influenzae type b conjugate vaccine,adsorbed,DTaP-IPV-Hib | Biological | Three doses of basic immunization were completed at 3, 4 and 5 months of age, and one dose of booster immunization was completed at 18 to 24 months of age. |
|
| DTcP | Biological | Three doses of basic immunization were completed at 2, 3 and 4 months of age, and one dose of booster immunization was completed at 18 to 24 months of age. |
|
| DTaP-IPV-Hib | Biological | Three doses of basic immunization were completed at 2, 3 and 4 months of age, and one dose of booster immunization was completed at 18 to 24 months of age. |
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| DTcP | Biological | Three doses of basic immunization were completed at 2, 4 and 6 months of age, and one dose of booster immunization was completed at 18 to 24 months of age. |
|
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
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| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| D017778 | Vaccines, Combined |
| C541234 | diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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