Trials / Not Yet Recruiting
Not Yet RecruitingNCT07418372
Phase I/II Clinical Trial of Diphtheria-Tetanus-Pertussis (Reduced Dose) Vaccine
A Randomized, Double-Blind, Parallel-Controlled Phase I/II Clinical Trial Evaluating the Safety and Immunogenicity of Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content) Among Individuals Aged 6 Years and Above
- Status
- Not Yet Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 660 (estimated)
- Sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences · Academic / Other
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | low-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content) | Low-dose vaccine, 0.5ml/dose, one dose at Day 0 |
| BIOLOGICAL | high-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content) | High-dose vaccine, 0.5ml/dose, one dose at Day 0 |
| BIOLOGICAL | Tetanus, Diphtheria and Acellular Pertussis Vaccine | DTaP controlled vaccine, 0.5ml/dose, one dose at Day 0 |
| BIOLOGICAL | 23-valent polysaccharide pneumococcal vaccine | PPV23 controlled vaccine, 0.5ml/dose, one dose at Day 0 |
Timeline
- Start date
- 2026-03-12
- Primary completion
- 2026-08-31
- Completion
- 2027-07-31
- First posted
- 2026-02-18
- Last updated
- 2026-02-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07418372. Inclusion in this directory is not an endorsement.