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This is a randomized, double-blinded, parallel-controlled phase I/II clinical trial to evaluate the safety and preliminary immunogenicity of the Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (reduced antigen content) in subjects aged 6 years and above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low-dose experimental group | Experimental | Participants aged 6 years and above |
|
| high-dose experimental group | Experimental | Participants aged 6 years |
|
| DTaP controlled group | Active Comparator | Participants aged 6 years |
|
| PPV23 controlled group | Placebo Comparator | Participants aged 7 years and above |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content) | Biological | Low-dose vaccine, 0.5ml/dose, one dose at Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety index - incidence of adverse events | Incidence of adverse events after vaccination | 0- 30 minutes/Day 0 to 7 days/Day 0 to 28 days after vaccination |
| Immunogenicity index - Geometric Mean Concentration (GMC) | The GMC of anti-DT, TT, PT, PRN, FHA antibodies 30 days after vaccination | Day 30 after vaccination |
| Immunogenicity index - Seropositive Rate | The seropositve rate of anti-DT, TT, PT, PRN, FHA antibodies 30 days after vaccination | Day 30 after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Safety index - incidence of serious adverse events | Incidence of serious adverse events after vaccination | From vaccination to 12 months after vaccination |
| Immunogenicity index - Seroconversion Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingsi Yang | Contact | 0871-68334551 | +86 | yjs@imbcams.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jiawei Xu | Chongqing Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangjin District Center for Disease Control and Prevention | Chongqing | Chongqing Municipality | China |
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| high-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content) | Biological | High-dose vaccine, 0.5ml/dose, one dose at Day 0 |
|
| Tetanus, Diphtheria and Acellular Pertussis Vaccine | Biological | DTaP controlled vaccine, 0.5ml/dose, one dose at Day 0 |
|
| 23-valent polysaccharide pneumococcal vaccine | Biological | PPV23 controlled vaccine, 0.5ml/dose, one dose at Day 0 |
|
The seroconversion rate of anti-DT, TT, PT, PRN, FHA antibodies 30 days after vaccination
| Between baseline and Day 30 after vaccination |
| Immunogenicity index - Geometric mean fold increases (GMFI) | The GMFI of anti-DT, TT, PT, PRN, FHA antibodies 30 days after vaccination | Between baseline and Day 30 after vaccination |
| ID | Term |
|---|---|
| D013742 | Tetanus |
| D004165 | Diphtheria |
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales 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 |
| D022681 | Diphtheria-Tetanus-acellular Pertussis Vaccines |
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D010567 | Pertussis Vaccine |
| D001428 | Bacterial Vaccines |
| D004168 | Diphtheria Toxoid |
| D017778 | Vaccines, Combined |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
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