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| Name | Class |
|---|---|
| Henan Center for Disease Control and Prevention | OTHER_GOV |
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Pertussis, diphtheria and tetanus are seriously infectious diseases in children. Since using of the vaccine targeted the three components, it greatly reduced incidence of the three kinds of diseases. The Purpose of this study is to preliminary evaluate the safety of DTcP compared to adsorbed diphtheria and tetanus combined vaccine (DT),Diphtheria-tetanus-acellular pertussis vaccine(DTaP) or PENTAXIM(DTaP-IPV-Hib) in participants.
Study participants will receive a single booster dose of DTcP or a single booster dose of local DT in 4 to 6 years old ,a singel booster dose of DTcP or a single booster dose of DTaP in 18 to 24 months, three basic doses of DTcP or three doses of DTaP/ DTaP-IPV-Hib in 2 to 6 months.Safety profile will be assessed in all subjects up to Day 30 post vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine 1A | Experimental | Subjects received one dose of DTaP aged 4 to 6 years. |
|
| Vaccine 1B | Active Comparator | Subjects received one dose of DT aged 4 to 6 years. |
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| Vaccine 2A | Experimental | Subjects received one dose of DTcP aged 18 to 24 months. |
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| Vaccine 2B | Active Comparator | Subjects received one dose of DTaP aged 18 to 24 months. |
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| Vaccine 3A | Experimental | Subjects received three doses of DTcP at 3,4,5 months of age. |
|
| Vaccine 3B |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed | Biological | 0.5 mL, Intramuscular Other Name: DTcP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety items of adverse reactions | Occurrence of adverse reactions | within 30 minutes post-vaccination |
| Safety items of adverse reactions | Occurrence of adverse reactions | within 7 days post-vaccination |
| Safety items of SAE: Occurrence of SAE | Occurrence of SAE | within 360 days post-vaccination |
| Safety itmes of laboratory measures: Occurrence of abnormal changes of laboratory measures | Occurrence of abnormal changes of laboratory measures | the fourth day post-vaccination |
| Safety items of adverse reactions | Occurrence of adverse reactions | within 8-30 days post-vaccination |
| Safety items of adverse reactions | Occurrence of adverse reactions | within 30 days post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wang Yanxia | Henan Province Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changge Center for Disease Control and Prevention | Xuchang | Henan | 461500 | China |
In order to maintain the rights of the subject, do not open the IPD
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| Active Comparator |
Subjects received three doses of DTaP at 3,4,5 months of age. |
|
| Vaccine 3C | Active Comparator | Subjects received three doses of DTaP-IPV-Hib at 3,4,5 months of age. |
|
| Vaccine 4A | Experimental | Subjects received three doses of DTcP at 2,3,4 months of age. |
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| Vaccine 4B | Active Comparator | Subjects received three doses of DTaP-IPV-Hib at 2,3,4 months of age. |
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| Vaccine 4C | Experimental | Subjects received three doses of DTcP at 2,4,6 months of age. |
|
| Diphtheria and Tetanus Combined Vaccine, Adsorbed | Biological | 2mL, Intramuscular Other Name: DT |
|
| Diphtheria-tetanus-acellular pertussis vaccine | Biological | 0.5 mL, Intramuscular Other Name: DTaP |
|
| Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine | Biological | 0.5 mL, Intramuscular Other Name: PENTAXIM |
|
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| D007239 | Infections |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D003015 | Clostridium Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| D017778 | Vaccines, Combined |
| D022681 | Diphtheria-Tetanus-acellular Pertussis Vaccines |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D010567 | Pertussis Vaccine |
| D001428 | Bacterial Vaccines |
| D004168 | Diphtheria Toxoid |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
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