Trials / Active Not Recruiting
Active Not RecruitingNCT06708286
A Clinical Trials of Adsorbed Cell-free DPT Vaccine (Five-component)
A Randomized, Blinded, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Adsorbed Cell-free DTP Vaccine (Five-component)
- Status
- Active Not Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 1,820 (actual)
- Sponsor
- CanSino Biologics Inc. · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp)) | 1 dose of Tdcp vaccine (0.5ml) on day 0 |
| BIOLOGICAL | 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) | 1 dose of PPV23 vaccine (0.5ml) on day 0 |
| BIOLOGICAL | Tdcp | 1 dose of Tdcp vaccine (0.5ml) on day 0 |
| BIOLOGICAL | PPV23 | 1 dose of PPV23 vaccine (0.5ml) on day 0 |
| BIOLOGICAL | Tdcp | 1 dose of Tdcp vaccine (0.5ml) on day 0 |
| BIOLOGICAL | PPV23 | 1 dose of PPV23 vaccine (0.5ml) on day 0 |
| BIOLOGICAL | Tdcp | 1 dose of Tdcp vaccine (0.5ml) on day 0 |
| BIOLOGICAL | PPV23 | 1 dose of PPV23 vaccine (0.5ml) on day 0 |
| BIOLOGICAL | Tdcp | 1 dose of Tdcp vaccine (0.5ml) on day 0 |
| BIOLOGICAL | Diphtheria-tetanus-acellular pertussis vaccine (DTaP) | 1 dose of DTaP vaccine (0.5ml) on day 0 |
Timeline
- Start date
- 2024-12-20
- Primary completion
- 2025-05-30
- Completion
- 2025-05-30
- First posted
- 2024-11-27
- Last updated
- 2025-03-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06708286. Inclusion in this directory is not an endorsement.