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This is a randomized, blinded, controlled phase II and III clinical trial evaluating the immunogenicity and safety of adsorbed cell-free DPT vaccine. 320 subjects aged 7 years and older in the phase II were divided into two age groups, the ≥18 years group and the 7-17 years group, and randomized 3:1 to receive the trial vaccine Tdcp versus the control vaccine PPV23. 1500 subjects in the phase III were divided into 3 age subgroups. 780 subjects were planned to be enrolled in the 6-year-old group and randomized 1:1 to receive the experimental vaccine Tdcp versus the control vaccine DTaP, and 360 subjects were planned to be enrolled in each of the 7-17 and ≥18 age groups and randomized 3:1 to receive the experimental vaccine Tdcp versus the control vaccine PPV23.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase II, ≥18 years old, Experimental vaccine | Experimental | One dose of Tdcp on Day 0 |
|
| Phase II, ≥18 years old, Control vaccine | Active Comparator | One dose of PPV23 on Day 0 |
|
| Phase II, 7-17 years old, Experimental vaccine | Experimental | One dose of Tdcp on Day 0 |
|
| Phase II, 7-17 years old, Control vaccine | Active Comparator | One dose of PPV23 on Day 0 |
|
| Phase III, ≥18 years old, Experimental vaccine | Experimental | One dose of Tdcp on Day 0 |
|
| Phase III, ≥18 years old, Control vaccine | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp)) | Biological | 1 dose of Tdcp vaccine (0.5ml) on day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: Incidence of adverse reactions | Within 0-30 days after vaccination | |
| Phase III: Geometric mean concentration (GMC) of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies | Pre-vaccination and 30 days post-vaccination | |
| Phase III: Proportion of serum anti-DT and TT antibodies ≥ 0.1IU/ml | 30 days after vaccination | |
| Phase III: Incidence of adverse reactions | Within 0-30 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: Incidence of adverse events/reactions | Within 30 minutes of vaccination | |
| Phase II: Incidence of adverse events/reactions | 0-7 days after vaccination | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanqing He | Ethical Review Committee for Clinical Trials of Zhejiang Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaihua County Center for Disease Control and Prevention | Kaihua | China |
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One dose of PPV23 on Day 0
|
| Phase III, 7-17 years old, Experimental vaccine | Experimental | One dose of Tdcp on Day 0 |
|
| Phase III, 7-17 years old, Control vaccine | Active Comparator | One dose of PPV23 on Day 0 |
|
| Phase III, 6 years old, Experimental vaccine | Experimental | One dose of Tdcp on Day 0 |
|
| Phase III, 6 years old, Control vaccine | Active Comparator | One dose of DTaP on Day 0 |
|
| 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) | Biological | 1 dose of PPV23 vaccine (0.5ml) on day 0 |
|
| Tdcp | Biological | 1 dose of Tdcp vaccine (0.5ml) on day 0 |
|
| PPV23 | Biological | 1 dose of PPV23 vaccine (0.5ml) on day 0 |
|
| Tdcp | Biological | 1 dose of Tdcp vaccine (0.5ml) on day 0 |
|
| PPV23 | Biological | 1 dose of PPV23 vaccine (0.5ml) on day 0 |
|
| Tdcp | Biological | 1 dose of Tdcp vaccine (0.5ml) on day 0 |
|
| PPV23 | Biological | 1 dose of PPV23 vaccine (0.5ml) on day 0 |
|
| Tdcp | Biological | 1 dose of Tdcp vaccine (0.5ml) on day 0 |
|
| Diphtheria-tetanus-acellular pertussis vaccine (DTaP) | Biological | 1 dose of DTaP vaccine (0.5ml) on day 0 |
|
| Phase II: Incidence of adverse events |
| 0-30 days after vaccination |
| Phase II: Incidence of serious stadverse events | Within 6 months of vaccination |
| Phase III: Positive rate of serum anti-Pertussis Toxoid (PT), Filamentous hemagglutmin (FHA), Pertactin (PRN), FIM 2&3, Diphtheria Toxoid (DT), Tetanus Toxoid (TT) antibodies | 30 days after vaccination |
| Phase III: Positive transfer rate of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies | 30 days after vaccination |
| Phase III: Geometric Mean Increase (GMI) of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies | 30 days after vaccination |
| Phase III: Incidence of adverse events/reactions | Within 30 minutes of vaccination |
| Phase III: Incidence of adverse events/reactions | 0-7 days after vaccination |
| Phase III: Incidence of adverse events | 0-30 days after vaccination |
| Phase III: Incidence of SAEs in subjects aged 7 years and older | Within 6 months of vaccination |
| Phase III: Incidence of SAEs in subjects aged 6 years | Within 12 months of vaccination |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| 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 |
| 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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